Drugs / Osimertinib
Regulatory milestones approvals, filings & regulatory actions · 16 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed lung cancer 2 milestones | |||||
| Filed | US (FDA) | Tagrisso | lung cancer | 2017-12-18 | “the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the use of Tagrisso (osimertinib)” astrazeneca.com ↗ |
| Filed | EU (EMA) | Tagrisso | lung cancer | 2017-11-28 | “the European Medicines Agency has accepted a variation to the Marketing Authorisation Application (MAAv) for Tagrisso (osimertinib)” astrazeneca.com ↗ |
| Filed non-small cell lung carcinoma 3 milestones | |||||
| Filed | US (FDA) | TAGRISSO | non-small cell lung carcinoma | 2026-09-29 | “today announces that AstraZeneca has submitted a New Drug Application (“NDA”) to the US Food and Drug Administration (“FDA”) for ORPATHYS® (savolitinib) plus TAGRISSO® (osimertinib)” hutch-med.com ↗ |
| Filed | US (FDA) | Tagrisso | non-small cell lung carcinoma | 2024-06-10 | “AstraZeneca’s supplemental New Drug Application (sNDA) for Tagrisso (osimertinib) has been accepted and granted Priority Review in the US” astrazeneca.com ↗ |
| Filed | US (FDA) | Tagrisso | non-small cell lung carcinoma | 2023-10-16 | “AstraZeneca’s supplemental New Drug Application (sNDA) for Tagrisso (osimertinib) in combination with chemotherapy has been accepted” astrazeneca.com ↗ |
| Filed RET fusion positive cancer 1 milestone | |||||
| Filed | Japan (PMDA) | Tagrisso | RET fusion positive cancer | 2017-11-27 | “submission of a supplemental new drug application (sNDA) to Japan’s Pharmaceuticals and Medical Devices Agency for the use of Tagrisso (osimertinib)” astrazeneca.com ↗ |
| Approved Indication not stated 5 milestones | |||||
| Filed | China (NMPA) | TAGRISSO | NSCLC with MET amplification after progression on first-line EGFR inhibitor therapy | 2025-01-02 | “This marks the first regulatory filing for the ORPATHYS® and TAGRISSO® combination.” hutch-med.com ↗ |
| Label expansions (6) | US (FDA) | TAGRISSO | — | 2017-03-30 – 2024-09-25 | fda.gov ↗ |
| Filed | US (FDA) | Tagrisso | early-stage non-small cell lung cancer | 2020-10-20 | “Tagrisso (osimertinib) has received acceptance for its supplemental New Drug Application (sNDA) and has also been granted Priority Review in the US” astrazeneca.com ↗ |
| Approved | EU (EMA) | Tagrisso | — | 2016-02-01 | europa.eu ↗ |
| Approved | US (FDA) | TAGRISSO | — | 2015-11-13 | fda.gov ↗ |
Trials 225 · started per year
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US approved 2015
EU approved 2016
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 trials | ||||||
| Phase 0 | NCT07458919 | Mar 2026 → Oct 2030 expected | lung cancer | Fuzhou General Hospital | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT06557096 | Aug 2024 → Jun 2027 expected | non-small cell lung carcinoma | Second Affiliated Hospital of Nanchang University | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT04135807 | Mar 2020 → Jan 2028 expected | anaplastic astrocytoma, anaplastic oligodendroglioma, brain oligodendroglioma, glioblastoma | Oliver Jonas | Recruiting | No outcome recorded |
| Phase 0 | NCT03755102 | Nov 2018 → Jul 2023 | lung cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 144 trials · 1 met primary · 1 missed | ||||||
| Phase 1 | NCT07361705 | Jan 2026 → Apr 2028 expected | — | Alpha Biopharma (Jiangsu) Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT07315113 | Dec 2025 → Dec 2026 expected | lung cancer | Nuvectis Pharma, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT06507306 | Jun 2024 → Dec 2026 expected | cancer | Kumquat Biosciences Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06362980 | May 2024 → Apr 2025 overdue | non-small cell lung carcinoma | National Cancer Center, China | Recruiting | No outcome recorded |
| Phase 1 | NCT05954871 | Jan 2024 → Sep 2025 | colorectal cancer, non-small cell lung carcinoma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06067776 | Jan 2024 → Jan 2025 overdue | non-small cell lung carcinoma | Jonathan Riess | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05401110 | Sep 2023 → Jan 2028 expected | non-small cell lung carcinoma | Karen Reckamp, MD, MS | Recruiting | No outcome recorded |
| Phase 1 | NCT06032936 | Jul 2023 → Mar 2024 | non-small cell lung carcinoma | LianBio LLC | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT05120960 | Feb 2023 → Apr 2024 | brain neoplasm | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT05693090 | Feb 2023 → Jul 2027 | non-small cell lung carcinoma | Kura Oncology, Inc. | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04772235 | Feb 2022 → Apr 2026 | non-small cell lung carcinoma | Instituto Oncológico Dr Rosell | Unknown | No outcome recorded |
| Phase 1 | NCT04780568 | Jan 2022 → Dec 2026 expected | non-small cell lung carcinoma | Ohio State University Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT05228015 | Jan 2022 → Aug 2024 | epithelioid hemangioendothelioma, malignant pleural mesothelioma | Ikena Oncology | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04959981 | Sep 2021 → Apr 2023 | non-small cell lung carcinoma | Erasca, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04862780 | Jun 2021 → Oct 2024 | adenocarcinoma, bronchogenic carcinoma, non-small cell lung carcinoma | Blueprint Medicines Corporation | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04676477 | Jun 2021 → Jan 2025 overdue | non-small cell lung carcinoma | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04798638 | Apr → Sep 2021 | — | TYK Medicines, Inc | Completed | No outcome recorded |
| Phase 1 | NCT04762199 | Feb 2021 → Dec 2026 expected | non-small cell lung carcinoma | Emory University | Recruiting | No outcome recorded |
| Phase 1 | NCT04721015 | Feb 2021 → Feb 2026 overdue | non-small cell lung carcinoma | AbbVie | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04541407 | Oct 2020 → Apr 2022 | non-small cell lung carcinoma | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 1 | NCT04141644 | Aug 2020 → Jan 2024 overdue | non-small cell lung carcinoma | University of Utah | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04001777 | Jul 2019 → Dec 2025 overdue | non-small cell lung carcinoma | Ascentage Pharma Group Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03891615 | Jun 2019 → Jul 2024 | lung cancer | Massachusetts General Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03810807 | Jan 2019 → Dec 2025 | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT03535363 | Oct 2018 → Apr 2022 | non-small cell lung carcinoma | Case Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT03567642 | Jun 2018 → Jun 2027 expected | lung cancer | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02923947 | May 2017 → Sep 2018 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02908750 | Mar → Jul 2017 | non-small cell lung carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02520778 | Aug 2016 → Oct 2022 | non-small cell lung carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT02496663 | May 2016 → Jun 2027 expected | non-small cell lung carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02529995 | Aug 2015 → Jan 2016 | non-small cell lung carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02491944 | Jul → Aug 2015 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02317016 | Mar → Jul 2015 | non-small cell lung carcinoma | AstraZeneca | Completed | Missed primary |
| Phase 1 | NCT02197234 | Dec 2014 → Apr 2015 | non-small cell lung carcinoma | AstraZeneca | Completed | Mixed |
| Phase 1 | NCT02161770 | Dec 2014 → May 2017 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02197247 | Dec 2014 → Jul 2015 | non-small cell lung carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02163733 | Nov 2014 → Mar 2015 | non-small cell lung carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02157883 | Nov 2014 → Apr 2015 | non-small cell lung carcinoma | AstraZeneca | Completed | Met primary |
| Phase 1 | NCT02228369 | Nov 2014 → Aug 2017 | lung cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02224053 | Sep 2014 → Jan 2015 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02143466 | Aug 2014 → Mar 2020 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02096679 | May → Aug 2014 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02099058 | Jan 2014 → Aug 2026 overdue | — | AbbVie | Active not recruiting | No outcome recorded |
| Phase 1 | NCT01951599 | Oct 2013 → Jun 2014 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1/227 trials · 1 met primary | ||||||
| Phase 1/2 | NCT07153055 | Aug 2026 → Apr 2029 expected | small cell lung carcinoma | Misty Shields | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07612137 | Jun 2026 → Jun 2027 expected | cancer | Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07486648 | May 2026 → Oct 2028 expected | non-small cell lung carcinoma | Shanxi Province Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07535437 | Apr 2026 → Apr 2028 expected | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07206498 | Oct 2025 → Oct 2028 expected | non-small cell lung carcinoma | Wayshine Biopharm, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06618287 | Feb 2025 → Feb 2031 expected | breast cancer, lung cancer | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06306456 | Mar 2024 → Dec 2025 overdue | non-small cell lung carcinoma | Suzhou Genhouse Bio Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06071013 | Feb 2024 → Aug 2026 overdue | non-small cell lung carcinoma | China Medical University Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05785741 | Aug 2023 → Dec 2027 expected | neoplasm | DualityBio Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05498389 | Jun 2023 → Jul 2024 | non-small cell lung carcinoma | Shanghai EpimAb Biotherapeutics Co., Ltd. | Unknown | No outcome recorded |
| Phase 1/2 | NCT05284994 | Mar 2022 → Apr 2024 | non-small cell lung carcinoma | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 1/2 | NCT05017025 | Feb 2022 → Sep 2026 | non-small cell lung carcinoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT04486833 | Sep 2021 → Mar 2028 expected | non-small cell lung carcinoma | Genprex, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04868877 | Apr 2021 → Mar 2026 overdue | colorectal cancer, esophageal squamous cell carcinoma, gastric cancer, head and neck squamous cell carcinoma +1 | Merus B.V. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04720976 | Mar 2021 → Dec 2023 | non-small cell lung carcinoma | Allist Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT04285671 | Jan 2021 → Dec 2026 expected | non-small cell lung carcinoma | Jonsson Comprehensive Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04770688 | Nov 2020 → Jun 2024 | lung adenocarcinoma, metastatic malignant neoplasm | Shanghai Chest Hospital | Completed | No outcome recorded |
| Phase 1/2 | NCT03831932 | Mar 2020 → Jun 2024 overdue | non-small cell lung carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03989115 | Jul 2019 → Feb 2022 | cancer | Revolution Medicines, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT03381274 | May 2018 → May 2021 overdue | non-small cell lung carcinoma | MedImmune LLC | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03450330 | Apr 2018 → Sep 2019 | non-small cell lung carcinoma | Dizal Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT03455829 | Mar 2018 → Dec 2021 | non-small cell lung carcinoma | G1 Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT03122717 | May 2017 → Oct 2026 expected | non-small cell lung carcinoma | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02917993 | Dec 2016 → Dec 2025 | lung cancer | Incyte Corporation | Completed | No outcome recorded |
| Phase 1/2 | NCT02954523 | Oct 2016 → Aug 2018 | non-small cell lung carcinoma | Chul Kim | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT02803203 | Jun 2016 → Mar 2022 | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Completed | Met primary |
| Phase 1/2 | NCT01802632 | Mar 2013 → May 2015 | non-small cell lung carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 2105 trials · 1 met primary · 6 missed | ||||||
| Phase 2 | NCT07622186 | Jul 2026 → Dec 2028 expected | non-small cell lung carcinoma | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT07669779 | Jul 2026 → Aug 2027 expected | non-small cell lung carcinoma | Akeso | Recruiting | No outcome recorded |
| Phase 2 | NCT07603791 | Jun 2026 → Dec 2027 expected | non-small cell lung carcinoma | Shanghai Allink Biotherapeutics Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07485452 | Jun 2026 → Jun 2027 expected | non-small cell lung carcinoma | Maastricht University Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07637448 | May 2026 → Mar 2029 expected | non-small cell lung carcinoma | Nanfang Hospital, Southern Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT07295821 | Apr 2026 → May 2029 expected | lung cancer | AstraZeneca | Recruiting | No outcome recorded |
| Phase 2 | NCT07329322 | Mar 2026 → Aug 2027 expected | non-small cell lung carcinoma | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT07323641 | Feb 2026 → Feb 2027 expected | non-small cell lung carcinoma | Jonsson Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07505173 | Jan 2026 → Jan 2028 expected | — | Tianjin Medical University Cancer Institute and Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07375316 | Dec 2025 → Jun 2028 expected | non-small cell lung carcinoma | Guangdong Association of Clinical Trials | Recruiting | No outcome recorded |
| Phase 2 | NCT07256509 | Nov 2025 → Nov 2026 expected | non-small cell lung carcinoma | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07058519 | Sep 2025 → Jan 2029 expected | non-small cell lung carcinoma | Shanghai Chest Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07177092 | Sep 2025 → Oct 2028 expected | EGF-related primary hypomagnesemia with intellectual disability, non-small cell lung carcinoma | Jianxing He | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06630325 | Jun 2025 → Mar 2026 | exocrine pancreatic carcinoma, female breast carcinoma, ovarian carcinoma, prostate carcinoma +1 | OHSU Knight Cancer Institute | Terminated | No outcome recorded |
| Phase 2 | NCT06918782 | May 2025 → Dec 2027 expected | non-small cell lung carcinoma | The University of Hong Kong | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07322783 | Jan 2025 → Dec 2026 expected | non-small cell lung carcinoma | Qingdao Central Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06692491 | Jan 2025 → Dec 2027 expected | — | Peking University Shenzhen Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06741085 | Dec 2024 → Dec 2027 expected | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06827145 | Oct 2024 → Sep 2026 overdue | non-small cell lung carcinoma | National Cancer Center, China | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06498986 | Jul 2024 → Jun 2027 expected | non-small cell lung carcinoma | Sichuan Baili Pharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06530719 | Jul 2024 → May 2026 overdue | non-small cell lung carcinoma | Jin Ying | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06436144 | Jun 2024 → Jun 2029 expected | non-small cell lung carcinoma | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06194448 | Apr 2024 → Jul 2026 overdue | lung cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06363734 | Apr 2024 → Dec 2025 overdue | non-small cell lung carcinoma | Tianjin Medical University Cancer Institute and Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06383728 | Apr 2024 → Oct 2025 overdue | squamous cell lung carcinoma | The First Affiliated Hospital of Guangzhou Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT06206850 | Feb 2024 → Jan 2029 expected | non-small cell lung carcinoma | Jair Bar, M.D., Ph.D. | Recruiting | No outcome recorded |
| Phase 2 | NCT06185400 | Feb 2024 → Jul 2025 overdue | non-small cell lung carcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06142617 | Dec 2023 → Nov 2027 expected | non-small cell lung carcinoma | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06018688 | Sep 2023 → Mar 2026 overdue | non-small cell lung carcinoma | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05773092 | Aug 2023 → Oct 2025 overdue | non-small cell lung carcinoma | National Cancer Centre, Singapore | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05801029 | Jul 2023 → Oct 2027 expected | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05526755 | Mar 2023 → Nov 2029 expected | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05546866 | Feb 2023 → Jun 2029 expected | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05686434 | Oct 2022 → Oct 2024 overdue | non-small cell lung carcinoma | Tianjin Medical University Cancer Institute and Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05536505 | Sep 2022 → Oct 2025 overdue | — | Guangdong Association of Clinical Trials | Recruiting | No outcome recorded |
| Phase 2 | NCT05528458 | Sep 2022 → Sep 2027 expected | lung adenocarcinoma | Samsung Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04908956 | Aug 2022 → Oct 2023 | non-small cell lung carcinoma | ETOP IBCSG Partners Foundation | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05085054 | Jun 2022 → May 2024 | non-small cell lung carcinoma | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Unknown | No outcome recorded |
| Phase 2 | NCT05163249 | May 2022 → Apr 2024 overdue | non-small cell lung carcinoma | Guangdong Association of Clinical Trials | Active not recruiting | Met primary |
| Phase 2 | NCT05089916 | Jan 2022 → Mar 2026 overdue | non-small cell lung carcinoma | AIO-Studien-gGmbH | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05215951 | Jan 2022 → Mar 2023 | lung cancer | AstraZeneca | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05298176 | Jan 2022 → Apr 2024 | non-small cell lung carcinoma | Amsterdam UMC, location VUmc | Completed | No outcome recorded |
| Phase 2 | NCT04769388 | Dec 2021 → Dec 2026 expected | non-small cell lung carcinoma | Beijing Cancer Prevention & Treatment Society | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06391944 | Nov 2021 → May 2023 overdue | non-small cell lung carcinoma | Shanghai JMT-Bio Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05132777 | Nov 2021 → Sep 2023 | non-small cell lung carcinoma | Shanghai JMT-Bio Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT05281406 | Nov 2021 → Nov 2025 overdue | non-small cell lung carcinoma | Goethe University | Recruiting | No outcome recorded |
| Phase 2 | NCT05011487 | Aug 2021 → Sep 2023 overdue | non-small cell lung carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT05507606 | Aug 2021 → Aug 2023 | non-small cell lung carcinoma | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04974879 | Jul 2021 → Jul 2024 | non-small cell lung carcinoma | Qingdao Central Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04335292 | Jan 2021 → Jun 2026 overdue | non-small cell lung carcinoma | Mark Vincent | Recruiting | No outcome recorded |
| Phase 2 | NCT04438902 | Dec 2020 → Dec 2022 | non-small cell lung carcinoma | First Affiliated Hospital of Zhejiang University | Terminated | No outcome recorded |
| Phase 2 | NCT04545710 | Nov 2020 → Dec 2025 overdue | lung cancer | University of California, San Diego | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04563871 | Nov 2020 → Oct 2023 | non-small cell lung carcinoma | Samsung Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT04606771 | Sep 2020 → Dec 2022 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05458726 | Sep 2020 → Jul 2022 | non-small cell lung carcinoma | Peking Union Medical College | Unknown | No outcome recorded |
| Phase 2 | NCT04233021 | Jul 2020 → Mar 2023 | metastatic malignant neoplasm in the brain, neoplastic meningitis, non-small cell lung carcinoma | French Cooperative Thoracic Intergroup | Completed | No outcome recorded |
| Phase 2 | NCT04811001 | Jun 2020 → Dec 2023 | non-small cell lung carcinoma | Fondazione Ricerca Traslazionale | Unknown | No outcome recorded |
| Phase 2 | NCT04322890 | Apr 2020 → Dec 2026 expected | non-small cell lung carcinoma | Hunan Province Tumor Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04644432 | Mar 2020 → Sep 2022 | renal cell carcinoma | Herlev and Gentofte Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04148898 | Nov 2019 → Mar 2021 | neoplastic meningitis, non-small cell lung carcinoma | Second Affiliated Hospital of Nanchang University | Unknown | No outcome recorded |
| Phase 2 | NCT03940703 | Sep 2019 → May 2023 overdue | non-small cell lung carcinoma | EMD Serono Research & Development Institute, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03497767 | Aug 2019 → Apr 2024 | non-small cell lung carcinoma | Trans Tasman Radiation Oncology Group | Completed | Missed primary |
| Phase 2 | NCT04029350 | Jul 2019 → Jan 2020 | non-small cell lung carcinoma | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03944772 | Jun 2019 → May 2025 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03810066 | Jun 2019 → Dec 2021 | non-small cell lung carcinoma | University Hospital, Essen | Completed | No outcome recorded |
| Phase 2 | NCT03865511 | Apr 2019 → Jan 2025 | non-small cell lung carcinoma | Nantes University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03769103 | Mar 2019 → Apr 2025 overdue | metastatic malignant neoplasm in the brain, non-small cell lung carcinoma | British Columbia Cancer Agency | Active not recruiting | Missed primary |
| Phase 2 | NCT03778229 | Jan 2019 → Aug 2024 overdue | carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04184921 | Jan 2019 → Jun 2023 | non-small cell lung carcinoma | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Completed | No outcome recorded |
| Phase 2 | NCT03784599 | Dec 2018 → May 2021 | non-small cell lung carcinoma | The Netherlands Cancer Institute | Terminated | No outcome recorded |
| Phase 2 | NCT03804580 | Dec 2018 → Jun 2025 | lung cancer | Vestre Viken Hospital Trust | Unknown | No outcome recorded |
| Phase 2 | NCT03732352 | Nov 2018 → Jan 2024 | RELA fusion-positive ependymoma, glioblastoma | Jonsson Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02824952 | Nov 2018 → Dec 2022 | non-small cell lung carcinoma | Shaare Zedek Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT03667820 | Sep 2018 → Sep 2027 expected | non-small cell lung carcinoma | University of Texas Southwestern Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03586453 | Aug 2018 → Feb 2028 expected | non-small cell lung carcinoma | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03433469 | Jul 2018 → Jan 2023 overdue | non-small cell lung carcinoma | University of California, San Francisco | Active not recruiting | Missed primary |
| Phase 2 | NCT03434418 | Jun 2018 → Oct 2022 | non-small cell lung carcinoma | Duke University | Completed | No outcome recorded |
| Phase 2 | NCT02971501 | Jun 2018 → Feb 2025 overdue | metastatic malignant neoplasm in the brain, non-small cell lung carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03239340 | May 2018 → Sep 2023 | lung cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT03191149 | Apr 2018 → Jun 2027 expected | non-small cell lung carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT03460275 | Feb 2018 → Dec 2020 | non-small cell lung carcinoma | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2 | NCT03392246 | Jan 2018 → Jun 2026 overdue | non-small cell lung carcinoma | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03410043 | Jan 2018 → Apr 2027 expected | non-small cell lung carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03414814 | Jan 2018 → Aug 2021 | — | Seoul National University Hospital | Completed | Missed primary |
| Phase 2 | NCT03543683 | Jan 2018 → Jan 2023 | non-small cell lung carcinoma | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Completed | No outcome recorded |
| Phase 2 | NCT02856893 | Oct 2017 → Sep 2022 | non-small cell lung carcinoma | European Organisation for Research and Treatment of Cancer - EORTC | Completed | No outcome recorded |
| Phase 2 | NCT04425681 | Oct 2017 → Jul 2020 | malignant leptomeningeal tumor, non-small cell lung carcinoma | Second Affiliated Hospital of Nanchang University | Unknown | No outcome recorded |
| Phase 2 | NCT03394118 | Aug 2017 → Mar 2021 | non-small cell lung carcinoma | Asan Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT03040973 | Jul 2017 → Jul 2027 expected | — | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03133546 | May 2017 → Feb 2021 | non-small cell lung carcinoma | ETOP IBCSG Partners Foundation | Completed | Missed primary |
| Phase 2 | NCT03257124 | May 2017 → Aug 2019 | lung cancer, metastatic malignant neoplasm in the brain | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT02811354 | Feb 2017 → Feb 2019 | non-small cell lung carcinoma | National University Hospital, Singapore | Unknown | No outcome recorded |
| Phase 2 | NCT02841579 | Sep 2016 → Dec 2018 | non-small cell lung carcinoma | MedSIR | Completed | No outcome recorded |
| Phase 2 | NCT02771314 | Aug 2016 → Jun 2020 | non-small cell lung carcinoma | Hellenic Oncology Research Group | Unknown | No outcome recorded |
| Phase 2 | NCT02769286 | Aug 2016 → Dec 2018 | lung neoplasm | Chonnam National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02736513 | May 2016 → Dec 2022 | lung cancer | Soroka University Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT02759835 | Apr 2016 → May 2022 | lung adenocarcinoma | National Cancer Institute (NCI) | Completed | Missed primary |
| Phase 2 | NCT06303167 | Jan 2016 → Feb 2023 overdue | plasma cell myeloma, refractory malignant neoplasm | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03424759 | Jan 2016 → Dec 2017 | non-small cell lung carcinoma | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT02465060 | Aug 2015 → Dec 2027 expected | breast carcinoma, carcinoma of esophagus, cervical carcinoma, colon carcinoma +17 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02504346 | Aug 2015 → Jun 2023 | lung cancer | Oslo University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02442349 | Jun 2015 → Mar 2016 | non-small cell lung carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT02664935 | May 2015 → Nov 2023 | adenocarcinoma, non-small cell lung carcinoma, squamous cell carcinoma | University of Birmingham | Completed | No outcome recorded |
| Phase 2 | NCT02179671 | Jul 2014 → Jun 2016 | non-small cell lung carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT02094261 | May 2014 → May 2015 | non-small cell lung carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 2/35 trials · 1 met primary | ||||||
| Phase 2/3 | NCT07642024 | Jun 2026 → Dec 2032 expected | non-small cell lung carcinoma | Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT07155187 | Dec 2025 → Sep 2030 expected | non-small cell lung carcinoma | AbbVie | Recruiting | No outcome recorded |
| Phase 2/3 | NCT06908772 | Apr 2025 → Dec 2028 expected | — | Shanghai JMT-Bio Inc. | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT05020769 | Jan 2022 → Dec 2025 overdue | non-small cell lung carcinoma | Sichuan Baili Pharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT02959749 | Aug 2015 → Oct 2017 | — | Qingdao Central Hospital | Completed | Met primary |
| Phase 330 trials · 9 met primary | ||||||
| Phase 3 | NCT07680790 | Sep 2026 → Dec 2031 expected | non-small cell lung carcinoma | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 3 | NCT07640789 | Aug 2026 → Dec 2030 expected | non-small cell lung carcinoma | Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06829459 | Apr 2025 → Feb 2028 expected | non-small cell lung carcinoma | Shanghai JMT-Bio Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06670196 | Nov 2024 → May 2027 expected | non-small cell lung carcinoma | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06735391 | Oct 2024 → Sep 2026 overdue | — | Shanghai JMT-Bio Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06417814 | Oct 2024 → Sep 2026 overdue | non-small cell lung carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06093503 | May 2024 → Apr 2028 | non-small cell lung carcinoma | AbbVie | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT06350097 | Apr 2024 → Mar 2028 expected | non-small cell lung carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06380348 | Apr 2024 → Mar 2027 expected | non-small cell lung carcinoma | Shanghai JMT-Bio Inc. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06323148 | Apr 2024 → Mar 2026 overdue | lung cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05629234 | May 2023 → Feb 2027 expected | cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05261399 | Aug 2022 → Jun 2026 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT05120349 | Feb 2022 → Aug 2027 expected | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05015608 | Nov 2021 → Aug 2025 | non-small cell lung carcinoma | Hutchison Medipharma Limited | Completed | Met primary |
| Phase 3 | NCT04816214 | Sep 2021 → Dec 2022 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04765059 | Sep 2021 → Oct 2024 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT04695925 | Mar 2021 → Nov 2025 overdue | non-small cell lung carcinoma | Li Zhang, MD | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05104281 | Jan 2021 → Dec 2023 | non-small cell lung carcinoma | Qingdao Central Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT04181060 | Dec 2020 → Jun 2029 expected | non-small cell lung carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 3 | NCT04351555 | Dec 2020 → Oct 2024 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT03833154 | Mar 2019 → Oct 2028 expected | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03521154 | Jul 2018 → Jan 2024 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT02997501 | Dec 2016 → Oct 2018 | lung cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02972333 | Dec 2016 → Sep 2019 | metastatic malignant neoplasm in the brain, non-small cell lung carcinoma | Shandong Cancer Hospital and Institute | Unknown | No outcome recorded |
| Phase 3 | NCT02511106 | Oct 2015 → Apr 2022 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT02474355 | Sep 2015 → Apr 2019 | lung cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02454933 | Jul 2015 → Aug 2017 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02411448 | May 2015 → Jan 2019 overdue | non-small cell lung carcinoma | Eli Lilly and Company | Active not recruiting | Met primary |
| Phase 3 | NCT02296125 | Dec 2014 → Jun 2017 | — | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT02151981 | Aug 2014 → Apr 2016 | — | AstraZeneca | Completed | Met primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT07279935 | May 2026 → May 2030 expected | non-small cell lung carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 4 | NCT05785208 | Jun 2022 → Feb 2024 | non-small cell lung carcinoma | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Unknown | No outcome recorded |
| Phase 4 | NCT04413201 | Sep 2020 → Dec 2026 expected | non-small cell lung carcinoma | Michael Hopp | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03853551 | Apr 2019 → Apr 2020 | non-small cell lung carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase not applicable5 trials · 1 missed | ||||||
| — | NCT07398599 | Feb 2026 → Dec 2027 expected | malignant leptomeningeal tumor, non-small cell lung carcinoma | Second Affiliated Hospital of Nanchang University | Recruiting | No outcome recorded |
| — | NCT06709274 | Nov 2024 → Jan 2029 expected | non-small cell lung carcinoma | Guangdong Association of Clinical Trials | Not yet recruiting | No outcome recorded |
| — | NCT06304441 | Apr 2024 → Jun 2026 overdue | neoplastic meningitis | Guangzhou Medical University | Recruiting | No outcome recorded |
| — | NCT04816838 | May 2021 → Jul 2025 | non-small cell lung carcinoma | Yonsei University | Unknown | Missed primary |
| — | NCT03969823 | May 2019 → Sep 2026 overdue | — | Seoul National University Hospital | Active not recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT02451852 | — | — | AstraZeneca | No longer available | No outcome recorded |
| Comparator or background therapy60 trials | ||||||
| Phase 1 | NCT06218940 Background | Dec 2024 → Dec 2026 expected | non-small cell lung carcinoma | Newsoara Biopharma Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05647122 Background | Dec 2022 → Jun 2026 overdue | colorectal neoplasm, head and neck neoplasm, non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05489731 Background | Sep 2022 → Feb 2024 | non-small cell lung carcinoma | Jiesi Yingda Pharmaceutical Technology (Suzhou) Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT05142189 Background | Jun 2022 → Feb 2030 expected | non-small cell lung carcinoma | BioNTech SE | Recruiting | No outcome recorded |
| Phase 1 | NCT05166616 Background | Mar 2022 → Oct 2027 expected | non-small cell lung carcinoma | City of Hope Medical Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05153408 Background | Jan → Dec 2022 | adenocarcinoma, bronchogenic carcinoma, non-small cell lung carcinoma | Blueprint Medicines Corporation | Terminated | No outcome recorded |
| Phase 1 | NCT06525246 Background | Aug 2021 → Jun 2025 | non-small cell lung carcinoma | Ono Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04479306 Background | Jun 2020 → Jul 2023 | non-small cell lung carcinoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT04085315 Background | Nov 2019 → Dec 2026 expected | lung cancer | Collin Blakely | Recruiting | No outcome recorded |
| Phase 1 | NCT03255083 Background | Apr 2019 → Sep 2020 | non-small cell lung carcinoma | Daiichi Sankyo | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT03463525 Background | Oct 2018 → Mar 2020 | non-small cell lung carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT07271446 Background | Sep 2018 → Aug 2019 | non-small cell lung carcinoma | Precision Biotech Taiwan Corp. | Completed | No outcome recorded |
| Phase 1 | NCT03418532 Background | Mar 2018 → Aug 2019 | non-small cell lung carcinoma | Molecular Partners AG | Terminated | No outcome recorded |
| Phase 1 | NCT02503722 Background | Mar 2017 → Feb 2027 expected | non-small cell lung carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02789345 Background | Oct 2016 → Oct 2017 | non-small cell lung carcinoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03050411 Background | May 2016 → Jun 2019 | non-small cell lung carcinoma | Peking University Third Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT07285148 Comparator | Jun 2026 → Dec 2029 expected | non-small cell lung carcinoma | Beijing Pearl Biotechnology Limited Liability Company | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07079475 Comparator | Jul 2025 → Jun 2028 expected | non-small cell lung carcinoma | Dizal Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06109558 Background | Dec 2023 → Dec 2026 expected | non-small cell lung carcinoma | Hunan Province Tumor Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04743505 Background | Jan 2022 → Jan 2027 expected | non-small cell lung carcinoma | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04665206 Background | Mar 2021 → Nov 2029 expected | mesothelioma, non-small cell lung carcinoma | Vivace Therapeutics, Inc | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03799094 Background | Dec 2018 → Dec 2020 | non-small cell lung carcinoma | Clifford Hospital, Guangzhou, China | Unknown | No outcome recorded |
| Phase 2 | NCT07710612 Background | Aug 2026 → Dec 2029 expected | non-small cell lung carcinoma | Abbisko Therapeutics Co, Ltd | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07379476 Comparator | Feb 2026 → Mar 2029 expected | non-small cell lung carcinoma | Chinese University of Hong Kong | Recruiting | No outcome recorded |
| Phase 2 | NCT07229729 Comparator | Nov 2025 → Oct 2026 expected | non-small cell lung carcinoma | Shanghai Hengrui Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT07038460 Background | Jul 2025 → Dec 2027 expected | non-small cell lung carcinoma | Wen-zhao ZHONG | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06895928 Background | Mar 2025 → Dec 2028 expected | cancer | Shanghai Hengrui Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06752408 Comparator | Dec 2024 → Jan 2027 expected | non-small cell lung carcinoma | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06014827 Background | Oct 2024 → Mar 2027 | non-small cell lung carcinoma | City of Hope Medical Center | Suspended | No outcome recorded |
| Phase 2 | NCT06574347 Comparator | Aug 2024 → Oct 2026 expected | non-small cell lung carcinoma | Avistone Biotechnology Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06452433 Background | Jun 2024 → Dec 2027 expected | non-small cell lung carcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06319950 Comparator | Apr 2024 → Dec 2026 expected | non-small cell lung carcinoma | Taizhou Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05948813 Comparator | Aug 2023 → Jun 2025 overdue | metastatic malignant neoplasm in the brain, non-small cell lung carcinoma | TYK Medicines, Inc | Recruiting | No outcome recorded |
| Phase 2 | NCT05880706 Background | Jul 2023 → Jul 2027 expected | non-small cell lung carcinoma | Sichuan Baili Pharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05642572 Background | May 2023 → Jun 2027 expected | non-small cell lung carcinoma | SWOG Cancer Research Network | Recruiting | No outcome recorded |
| Phase 2 | NCT05816252 Background | Apr 2023 → Jun 2026 overdue | non-small cell lung carcinoma | Klus Pharma Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04591002 Comparator | Sep 2022 → Sep 2027 expected | lung cancer | Samsung Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04988607 Comparator | Aug 2021 → Nov 2024 | lung cancer | Guangdong Association of Clinical Trials | Unknown | No outcome recorded |
| Phase 2 | NCT04829019 Comparator | Apr 2021 → Apr 2024 | cognitive disorder | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2 | NCT04764214 Background | Mar 2021 → Mar 2023 | non-small cell lung carcinoma | Fudan University | Completed | No outcome recorded |
| Phase 2 | NCT04410796 Background | May 2020 → May 2027 expected | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT03909334 Comparator | Jul 2019 → Dec 2026 expected | metastatic malignant neoplasm, non-small cell lung carcinoma | Xiuning Le | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT07005102 Background | Aug 2025 → Nov 2036 expected | non-small cell lung carcinoma | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT07738172 Background | Sep 2026 → Aug 2031 expected | non-small cell lung carcinoma | National Taiwan University Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT07376382 Background | Jun → Dec 2026 expected | non-small cell lung carcinoma | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07185997 Comparator | Dec 2025 → Feb 2029 expected | non-small cell lung carcinoma | ArriVent BioPharma, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06838273 Comparator | Feb 2025 → Dec 2028 expected | non-small cell lung carcinoma | Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06970639 Comparator | Sep 2024 → Mar 2029 expected | — | Allist Pharmaceuticals, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT05624996 Background | Jul 2023 → Oct 2031 expected | non-small cell lung carcinoma | NRG Oncology | Recruiting | No outcome recorded |
| Phase 3 | NCT05493501 Comparator | Dec 2022 → Aug 2023 | non-small cell lung carcinoma | EQRx International, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT06486142 Comparator | Sep 2022 → Sep 2028 expected | non-small cell lung carcinoma | Region Skane | Recruiting | No outcome recorded |
| Phase 3 | NCT05382728 Comparator | Jun 2022 → May 2025 overdue | non-small cell lung carcinoma | TYK Medicines, Inc | Recruiting | No outcome recorded |
| Phase 3 | NCT05009836 Background | Sep 2021 → May 2028 expected | non-small cell lung carcinoma | Hutchmed | Active not recruiting | Met primary |
| Phase 3 | NCT04870190 Comparator | Jun 2021 → Jun 2024 | non-small cell lung carcinoma | Shanghai Chest Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT04487080 Comparator | Sep 2020 → Aug 2023 overdue | non-small cell lung carcinoma | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 3 | NCT04035486 Comparator | Jul 2019 → Apr 2023 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | Met primary |
| Phase 4 | NCT06824792 Background | Mar 2025 → Feb 2028 expected | cancer | NING LI | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04401059 Comparator | Nov 2020 → Sep 2025 | adenocarcinoma, non-small cell lung carcinoma | Tian Xie | Unknown | No outcome recorded |
| Phase 4 | NCT04356118 Background | Jun 2020 → Jun 2023 | malignant leptomeningeal tumor | Hui Bu | Unknown | No outcome recorded |
| — | NCT05583409 Comparator | Jan 2023 → Dec 2024 | non-small cell lung carcinoma | Li Zhang | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 138
| Date | Issuer | Release |
|---|---|---|
| 2026-09-29 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces Submission of US NDA for ORPATHYS® plus TAGRISSO® in MET-Driven EGFR-Mutated Lung Cancer hutch-med.com ↗ |
| 2026-09-24 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Results VOLUNTARY ANNOUNCEMENT - PHASE III CLINICAL TRIAL OF BECOTATUG (JMT101) IN COMBINATION WITH OSIMERTINIB FOR THE FIRST-LINE TREATMENT OF LOCALLY ADVANCED OR METASTATIC NSCLC HARBOURING EGFR EXON 20 INSERTION MUTATIONS ACHIEVES POSITIVE TOPLINE RESULTS irasia.com ↗ |
| 2026-09-22 | Iterion Therapeutics | Results Iterion Therapeutics Announces Promising Phase 1b Data for Tegavivint in Combination with Osimertinib in First-Line EGFR-Mutated Non-Small Cell Lung Cancer iteriontherapeutics.com ↗ |
| 2026-09-14 | Alexion Pharmaceuticals, Inc. | Results Tagrisso demonstrated unprecedented eight-year landmark survival in early-stage EGFR-mutated lung cancer in ADAURA Phase III trial astrazeneca.com ↗
Updated exploratory results from the ADAURA Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at eight years compared to placebo in the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent. |
| 2026-09-01 | Alexion Pharmaceuticals, Inc. | Results Tagrisso plus Orpathys demonstrated statistically significant and highly clinically meaningful improvement in progression-free survival in 1st-line MET-overexpressing EGFR-mutated lung cancer astrazeneca.com ↗
The PFS benefit was demonstrated in both the high MET (IHC 3+) and the intention-to-treat (ITT) trial populations (IHC 2+, IHC 3+). |
| 2026-08-31 | Hutchison Medipharma Limited | Results HUTCHMED Announces SANOVO Trial Demonstrated Significant Progression-Free Survival Benefit of ORPATHYS® Plus TAGRISSO® in Treatment-Naïve Patients with MET-Overexpressing EGFR-mutated Lung Cancer in China hutch-med.com ↗
ORPATHYS® (savolitinib) plus TAGRISSO® (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (“PFS”) versus TAGRISSO® alone in both the high MET and intention-to-treat (“ITT”) patient populations. |
| 2026-08-17 | Hutchison Medipharma Limited | Results HUTCHMED Announces ORPATHYS® Plus TAGRISSO® Demonstrated Statistically Significant and Clinically Meaningful Improvements in Progression-Free and Overall Survival in MET-Driven EGFR-Mutated Lung Cancer After Progression on TAGRISSO® hutch-med.com ↗ |
| 2026-08-17 | Alexion Pharmaceuticals, Inc. | Results Tagrisso plus Orpathys demonstrated statistically significant and clinically meaningful improvements in progression-free and overall survival in MET-driven EGFR-mutated lung cancer after progression on Tagrisso astrazeneca.com ↗ |
| 2026-06-22 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results Translational Research Results of Sacituzumab Tirumotecan (sac-TMT) in Combination with Osimertinib as First-Line Treatment for EGFR-Mutant NSCLC Published in Cancer Cell kelun-biotech.com ↗
The study shows that EGFR-TKIs induce TROP2 upregulation in DTP cells, providing a mechanistic basis for combining sac-TMT with EGFR-TKI. |
| 2026-06-22 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results Translational Research Results of Sacituzumab Tirumotecan (sac-TMT) in Combination with Osimertinib as First-Line Treatment for EGFR-Mutant NSCLC Published in Cancer Cell kelun-biotech.com ↗
The study shows that trophoblast cell-surface antigen 2 (TROP2) expression is upregulated in residual drug-tolerant persister (DTP) cells after EGFR tyrosine kinase inhibitor (TKI) treatment; in preclinical models, sac-TMT combined with osimertinib inhibited DTP cell formation and delayed tumor recurrence. |
| 2026-01-14 | Hutchison Medipharma Limited | Results HUTCHMED Highlights Publication of Phase III SACHI Results in The Lancet hutch-med.com ↗
The SACHI trial, now published in The Lancet, provides compelling evidence that savolitinib combined with osimertinib can transform outcomes for patients with EGFR-mutated NSCLC with MET amplification. |
| 2025-11-24 | Genprex, Inc. | Results Data from Genprex’s Acclaim-1 Phase 1 Gene Therapy Clinical Trial Published in Clinical Lung Cancer genprex.com ↗
The Phase 1 dose escalation portion of the trial was designed primarily to assess safety, however, the Company believes promising efficacy results were also observed. |
| 2025-09-07 | Janssen Research & Development, LLC | Results Data published in The New England Journal of Medicine demonstrate RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) is re-setting survival expectations in first-line EGFR-mutated lung cancer jnj.com ↗
At a median follow-up of 37.8 months, RYBREVANT®plus LAZCLUZE®showed a statistically significant reduction in the risk of death compared to osimertinib (hazard ratio [HR], 0.75; 95 percent confidence interval [CI], 0.61-0.92, P=0.005). |
| 2025-09-07 | Janssen Research & Development, LLC | Results Data published in The New England Journal of Medicine demonstrate RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) is re-setting survival expectations in first-line EGFR-mutated lung cancer jnj.com ↗
Median OS for the combination is projected to exceed over four years (absolute increase of over one year) compared to the median of three years observed with osimertinib. |
| 2025-09-07 | AstraZeneca | Results Tagrisso plus chemotherapy demonstrated a median overall survival of nearly four years, the longest benefit ever reported in a global Phase III trial in EGFR-mutated advanced lung cancer astrazeneca.com ↗
In the final OS analysis, Tagrisso plus chemotherapy demonstrated a median OS of nearly four years (47.5 months) compared to approximately three years (37.6 months) for Tagrisso monotherapy. |
| 2025-09-06 | Janssen Research & Development, LLC | Results RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) prevents acquired resistance versus osimertinib in first-line EGFR-mutated non-small cell lung cancer jnj.com ↗ |
| 2025-09-06 | Janssen Research & Development, LLC | Results RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) prevents acquired resistance versus osimertinib in first-line EGFR-mutated non-small cell lung cancer jnj.com ↗ |
| 2025-09-04 | Janssen Research & Development, LLC | Results RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) offers unmatched survival benefit in a chemotherapy-free regimen, reducing treatment resistance vs osimertinib in first-line EGFR-mutated NSCLC jnj.com ↗ |
| 2025-07-21 | AstraZeneca | Results Tagrisso plus chemotherapy demonstrated statistically significant and clinically meaningful improvement in overall survival in EGFR-mutated advanced lung cancer astrazeneca.com ↗
These positive results support osimertinib, either as monotherapy or in combination with chemotherapy, as standard of care for patients with 1st-line advanced EGFR -mutated lung cancer and reinforce the meaningful benefit of the combination in the current clinical setting. |
| 2025-06-30 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces China Approval for ORPATHYS® in Combination with TAGRISSO® for the Treatment of Lung Cancer Patients with MET Amplification After Progression on First-Line EGFR Inhibitor Therapy hutch-med.com ↗
This new approval by the NMPA was based on data from the SACHI Phase III trial of the ORPATHYS® and TAGRISSO® combination (NCT05015608), having met the pre-defined primary endpoint of progression-free survival (“PFS”) in a pre-planned interim analysis. |
| 2025-06-02 | Hutchison Medipharma Limited | Results HUTCHMED Highlights SACHI Phase III Study Data Presented at the 2025 ASCO Annual Meeting hutch-med.com ↗
The all-oral chemotherapy-free combination of savolitinib plus osimertinib demonstrated significant PFS benefit with a favorable safety profile in the SACHI Phase III China study |
| 2025-05-23 | Hutchison Medipharma Limited | Results HUTCHMED Highlights Clinical Data to be Presented at the 2025 ASCO Annual Meeting hutch-med.com ↗
SACHI had met the pre-defined primary endpoint of progression-free survival (PFS) in a planned interim analysis. |
| 2025-03-26 | Janssen Research & Development, LLC | Results RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) outperforms osimertinib with a significant and unprecedented overall survival benefit in patients with EGFR-mutated non-small cell lung cancer jnj.com ↗
This is the first and only study to show a statistically significant and clinically meaningful OS improvement over osimertinib. |
| 2025-03-26 | Janssen Research & Development, LLC | Results RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) outperforms osimertinib with a significant and unprecedented overall survival benefit in patients with EGFR-mutated non-small cell lung cancer jnj.com ↗
Median OS is projected to exceed one year beyond the median of three years observed with osimertinib and has not yet been reached. |
| 2025-03-25 | AstraZeneca | Results New study results reinforce Tagrisso as the backbone therapy for EGFR-mutated lung cancer across stages and settings astrazeneca.com ↗
In LAURA Phase III trial, Tagrisso continues to demonstrate improved overall survival trend in unresectable, Stage III setting |
| 2025-03-20 | Janssen Research & Development, LLC | Results RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) significantly outperforms standard of care in first-line EGFR-mutated lung cancer with compelling new data at ELCC 2025 jnj.com ↗ |
| 2025-03-20 | Janssen Research & Development, LLC | Results RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) significantly outperforms standard of care in first-line EGFR-mutated lung cancer with compelling new data at ELCC 2025 jnj.com ↗
Median overall survival improvement projected to exceed one year with much-anticipated overall survival analysis showing statistically superior result versus osimertinib |
| 2025-03-20 | Hutchison Medipharma Limited | Results HUTCHMED Highlights Savolitinib SAVANNAH Phase II and Other Data at European Lung Cancer Congress 2025 hutch-med.com ↗
SAVANNAH Phase II trial demonstrated high and durable response rates with savolitinib plus TAGRISSO® in MET-high lung cancer, representing a promising chemo-free oral treatment strategy to address mechanisms of resistance in the advanced setting |
| 2025-03-04 | Nuvectis Pharma, Inc. | Results Nuvectis Pharma Announces a New Publication of a Research Study Demonstrating that the Combination of NXP900 and EGFR Inhibitors Improves the Efficacy of the EGFR Inhibitors in Preclinical Models of EGFR Mutated NSCLC nuvectis.com ↗ |
| 2025-01-02 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces NDA Acceptance in China with Priority Review Status for ORPATHYS® and TAGRISSO® Combination in Lung Cancer Patients with MET amplification After Progression on First-Line EGFR Inhibitor Therapy hutch-med.com ↗
has been accepted and granted priority review by the China National Medical Products Administration (“NMPA”). |
| 2024-12-23 | AstraZeneca | Regulatory Tagrisso approved in the EU for patients with unresectable EGFR-mutated lung cancer astrazeneca.com ↗
AstraZeneca’s Tagrisso (osimertinib) has been approved in the European Union (EU) for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor ( EGFR ) exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy (CRT). |
| 2024-12-12 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces Breakthrough Therapy Designation in China for ORPATHYS® and TAGRISSO® Combination in Certain Lung Cancer Patients After Disease Progression on EGFR Inhibitor Therapy hutch-med.com ↗ |
| 2024-11-18 | AstraZeneca | Regulatory Tagrisso recommended for approval in the EU by CHMP for patients with unresectable EGFR-mutated lung cancer astrazeneca.com ↗
AstraZeneca’s Tagrisso (osimertinib) has been recommended for approval in the European Union (EU) for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor ( EGFR ) exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy (CRT). |
| 2024-10-16 | Hutchison Medipharma Limited | Results HUTCHMED Announces that TAGRISSO® plus ORPATHYS® demonstrated high, clinically meaningful response rate in lung cancer patients with high levels of MET overexpression and/or amplification in SAVANNAH Phase II trial hutch-med.com ↗ |
| 2024-09-26 | AstraZeneca | Regulatory Tagrisso approved in the US for patients with unresectable, Stage III EGFR-mutated lung cancer astrazeneca.com ↗
Tagrisso is indicated for patients with exon 19 deletions or exon 21 (L858R) mutations, as detected by a FDA-approved test. |
| 2024-09-10 | Hutchison Medipharma Limited | Results HUTCHMED Highlights Clinical Data to be Presented at ESMO Congress 2024 and the 2024 World Conference of Lung Cancer hutch-med.com ↗
Patients treated with osimertinib plus savolitinib (Cohort 2, N=21) showed deeper and more durable response over osimertinib monotherapy (Cohort 1, N=23) along the study follow-up. |
| 2024-09-08 | Janssen Research & Development, LLC | Results RYBREVANT ® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) show strong favorable overall survival trend versus osimertinib in EGFR-mutated advanced lung cancer jnj.com ↗ |
| 2024-09-08 | Janssen Research & Development, LLC | Results RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) show strong favorable overall survival trend versus osimertinib in EGFR-mutated advanced lung cancer jnj.com ↗ |
| 2024-08-15 | Genprex, Inc. | Results Genprex Releases New Video Featuring Chief Medical Officer Discussing Positive Patient Outcomes in Two Lung Cancer Clinical Trials genprex.com ↗
Both of these patients’ outcomes are fairly remarkable in terms of their prolonged Progression Free Survival (PFS) among patients in the study who were progressing on their previous treatment when they came into the study. |
| 2024-08-14 | Genprex, Inc. | Results Genprex Announces Positive Clinical Study Updates from Acclaim-1 and Acclaim-3 Phase 1/2 Clinical Trials in Lung Cancer genprex.com ↗
Two patients in the Acclaim-1 study have had prolonged Progression Free Survival (PFS) and importantly, the first treated patient in the Acclaim-3 study attained a Partial Remission (PR) from the start of maintenance therapy. |
| 2024-07-05 | AstraZeneca | Regulatory Tagrisso with the addition of chemotherapy approved in the EU as new 1st-line treatment for patients with EGFR-mutated advanced lung cancer astrazeneca.com ↗ |
| 2024-06-26 | AstraZeneca | Regulatory Tagrisso with the addition of chemotherapy approved in China as 1st-line treatment for patients with EGFR-mutated advanced lung cancer astrazeneca.com ↗ |
| 2024-06-25 | AstraZeneca | Regulatory Tagrisso with the addition of chemotherapy approved in Japan as new 1st-line treatment for patients with EGFR-mutated advanced lung cancer astrazeneca.com ↗
AstraZeneca’s Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy has been approved in Japan for the 1st-line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations. |
| 2024-06-10 | AstraZeneca | Regulatory Tagrisso granted Priority Review in the US for patients with unresectable, Stage III EGFR-mutated lung cancer astrazeneca.com ↗ |
| 2024-06-03 | AstraZeneca | Regulatory Tagrisso with the addition of chemotherapy recommended for approval in the EU by CHMP for patients with EGFR-mutated advanced lung cancer astrazeneca.com ↗
AstraZeneca’s Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy has been recommended for approval in the European Union (EU) for 1st-line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations. |
| 2024-06-03 | Puma Biotechnology, Inc. | Results Puma Biotechnology Announces Presentation of Findings from a Phase I/Ib Study of Alisertib in Advanced EGFR-Mutated Lung Cancer pumabiotechnology.com ↗
Intermittent alisertib 30 mg BID was identified as the MTD and RP2D in combination with osimertinib 80 mg daily. |
| 2024-06-02 | AstraZeneca | Results Tagrisso reduced the risk of disease progression or death by 84% in patients with unresectable, Stage III EGFR-mutated lung cancer vs. placebo in LAURA Phase III trial astrazeneca.com ↗
Results showed Tagrisso reduced the risk of disease progression or death by 84% compared to placebo (hazard ratio [HR] 0.16; 95% confidence interval [CI] 0.10-0.24; p<0.001) as assessed by blinded independent central review (BICR). |
| 2024-05-31 | Janssen Research & Development, LLC | Results RYBREVANT® (amivantamab-vmjw) plus lazertinib is the only chemotherapy-free regimen showing longer progression-free survival versus osimertinib in first-line treatment of patients with high-risk EGFR-mutated non-small cell lung cancer jnj.com ↗
Results from the new analysis show the RYBREVANT®combination consistently and significantly improved progression-free survival (PFS) compared to osimertinib in patients with NSCLC with EGFR exon 19 deletion (ex19del) or L858R mutations. |
| 2024-05-31 | Janssen Research & Development, LLC | Results RYBREVANT® (amivantamab-vmjw) plus lazertinib is the only chemotherapy-free regimen showing longer progression-free survival versus osimertinib in first-line treatment of patients with high-risk EGFR-mutated non-small cell lung cancer jnj.com ↗
Results from the new analysis show the RYBREVANT® combination consistently and significantly improved progression-free survival (PFS) compared to osimertinib in patients with NSCLC with EGFR exon 19 deletion (ex19del) or L858R mutations. |
| 2024-04-08 | Nuvectis Pharma, Inc. | Results Nuvectis Pharma's NXP900 Demonstrates Robust Activity in Non-Small Cell Lung Cancer Cell Lines nuvectis.com ↗
The data reported, which confirms data previously published by the research team at Astra Zeneca, demonstrated that the combination reverses resistance to osimertinib versus osimertinib alone. |
| 2024-03-21 | AstraZeneca | Results Tagrisso with the addition of chemotherapy showed favourable trend in overall survival in EGFR-mutated advanced lung cancer with further follow up in FLAURA2 Phase III trial astrazeneca.com ↗
Tagrisso with the addition of chemotherapy also demonstrated a favourable trend toward overall survival (OS) improvement at two years of follow up. |
| 2024-02-19 | AstraZeneca | Regulatory Tagrisso with the addition of chemotherapy approved in the US for patients with EGFR-mutated advanced lung cancer astrazeneca.com ↗
AstraZeneca’s Tagrisso (osimertinib) with the addition of chemotherapy has been approved in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). |
| 2024-02-19 | AstraZeneca | Results Tagrisso demonstrated overwhelming efficacy benefit for patients with unresectable, Stage III EGFR-mutated lung cancer in LAURA Phase III trial astrazeneca.com ↗
LAURA shows osimertinib can provide impactful clinical benefit and could become the first targeted treatment option for patients with Stage III disease. |
| 2024-01-01 | Alembic Pharmaceuticals Ltd. | Regulatory Press Release USFDA Products Approvals For the Qtr ended 31st Dec, 2023 alembicpharmaceuticals.com ↗ |
| 2023-10-23 | Janssen Research & Development, LLC | Results Landmark Phase 3 MARIPOSA Study Shows RYBREVANT® (amivantamab-vmjw) Plus Lazertinib Resulted in 30 Percent Reduction in Risk of Disease Progression or Death Compared to Osimertinib in Patients with EGFR-Mutated Non-Small Cell Lung Cancer jnj.com ↗
With the combination of RYBREVANT and lazertinib in the MARIPOSA study, progression-free survival was significantly improved in patients with previously untreated EGFR-mutated NSCLC compared to osimertinib. |
| 2023-10-23 | Janssen Research & Development, LLC | Results Landmark Phase 3 MARIPOSA Study Shows RYBREVANT® (amivantamab-vmjw) Plus Lazertinib Resulted in 30 Percent Reduction in Risk of Disease Progression or Death Compared to Osimertinib in Patients with EGFR-Mutated Non-Small Cell Lung Cancer jnj.com ↗ |
| 2023-10-23 | Ascentage Pharma Group Inc. | Results Live from ESMO 2023 | Oral Report Featuring Latest Data of Pelcitoclax (APG-1252) Combined with Osimertinib Demonstrates Potential as a New Treatment Option for TP53-and EGFR-Mutant NSCLC ascentage.com ↗
The clinical data presented at the ESMO Congress this year demonstrated promising therapeutic utility of pelcitoclax combined with osimertinib in patients with EGFR-mutant NSCLC. |
| 2023-10-21 | AstraZeneca | Results Tagrisso plus chemotherapy reduced the risk of disease progression in the brain by 42% in patients with EGFR-mutated advanced lung cancer and brain metastases at baseline astrazeneca.com ↗
With two years of follow-up, 74% of patients treated with Tagrisso plus chemotherapy had not experienced CNS disease progression or death versus 54% of patients treated with Tagrisso monotherapy. |
| 2023-10-16 | AstraZeneca | Regulatory Tagrisso plus chemotherapy granted Priority Review in the US for patients with EGFR-mutated advanced lung cancer astrazeneca.com ↗ |
| 2023-10-04 | Genprex, Inc. | Results Genprex to Present Data on the Use of REQORSA® for the Treatment of Lung Cancers at 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics genprex.com ↗
Of the 12 patients treated with escalating doses of REQORSA and standard doses of Tagrisso, all of whom had progressed on Tagrisso containing regimens, two patients experienced prolonged time to progression, including one with continuing partial response. |
| 2023-09-28 | Janssen Research & Development, LLC | Results Landmark Phase 3 MARIPOSA Study Meets Primary Endpoint Resulting in Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival for RYBREVANT® (amivantamab-vmjw) plus Lazertinib Versus Osimertinib in Patients with EGFR-Mutated Non-Small Cell Lung Cancer jnj.com ↗
The pivotal Phase 3 MARIPOSA study met its primary endpoint with a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients receiving RYBREVANT®plus lazertinib compared to osimertinib. |
| 2023-09-28 | Janssen Research & Development, LLC | Results Landmark Phase 3 MARIPOSA Study Meets Primary Endpoint Resulting in Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival for RYBREVANT® (amivantamab-vmjw) plus Lazertinib Versus Osimertinib in Patients with EGFR-Mutated Non-Small Cell Lung Cancer jnj.com ↗
The pivotal Phase 3 MARIPOSA study met its primary endpoint with a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients receiving RYBREVANT® plus lazertinib compared to osimertinib. |
| 2023-09-11 | AstraZeneca | Results Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months in EGFR-mutated advanced lung cancer in FLAURA2 Phase III trial astrazeneca.com ↗
Results showed Tagrisso plus chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso alone (based on a hazard ratio [HR] of 0.62; 95% confidence interval [CI] 0.49-0.79; p<0.0001). |
| 2023-08-16 | AstraZeneca | Regulatory AstraZeneca data at WCLC advance ambition to have an AstraZeneca medicine for more than half of all patients treated for lung cancer by 2030 astrazeneca.com ↗
In August, Tagrisso plus chemotherapy was granted Breakthrough Therapy Designation in the US for advanced EGFRm NSCLC. |
| 2023-06-05 | Erasca, Inc. | Results Erasca Provides Update on Clinical Program for ERK Inhibitor ERAS-007 and Refines Pipeline erasca.com ↗ |
| 2023-06-04 | AstraZeneca | Results Tagrisso achieved unprecedented survival in early-stage EGFR-mutated lung cancer, with 88% of patients alive at five years in ADAURA Phase III trial astrazeneca.com ↗
Treatment with adjuvant Tagrisso reduced the risk of death by more than half |
| 2023-05-30 | Genprex, Inc. | Results Genprex Receives Safety Review Committee Approval to Advance to Phase 2 Expansion Portion of Acclaim-1 Clinical Trial of REQORSA® in Combination with Tagrisso® in Advanced Non-Small Cell Lung Cancer genprex.com ↗
Based on full safety data which showed no dose limiting toxicities, the SRC determined that the recommended Phase 2 dose of REQORSA will be 0.12 mg/kg. |
| 2023-05-25 | Genprex, Inc. | Results Genprex Publishes Positive Clinical Data from Phase 1 Portion of Acclaim-1 Clinical Trial Evaluating REQORSA® Immunogene Therapy in Non-Small Cell Lung Cancer at the 2023 ASCO Annual Meeting genprex.com ↗
Results Show Combination of REQORSA® and Tagrisso® was Well Tolerated at All Three Dose Levels of Phase 1 Trial with Encouraging Evidence of Efficacy Observed |
| 2023-05-17 | AstraZeneca | Results Tagrisso plus chemotherapy demonstrated strong improvement in progression-free survival for patients with EGFR-mutated advanced lung cancer in FLAURA2 Phase III trial astrazeneca.com ↗ |
| 2023-03-09 | AstraZeneca | Results Tagrisso demonstrated strong overall survival benefit in the ADAURA Phase III trial for adjuvant treatment of patients with early-stage EGFR-mutated lung cancer astrazeneca.com ↗
These new survival data for osimertinib reinforce the unprecedented ADAURA disease-free survival results and confirm its potential to extend patients’ lives in early-stage disease. |
| 2023-03-09 | AstraZeneca | Results Imfinzi significantly improved event-free survival in AEGEAN Phase III trial for patients with resectable non-small cell lung cancer astrazeneca.com ↗ |
| 2022-09-11 | AstraZeneca | Results Tagrisso demonstrated 5.5-year median disease-free survival in the adjuvant treatment of patients with EGFR-mutated lung cancer astrazeneca.com ↗
A median DFS of nearly five and a half years (65.8 months) was seen in both the primary and overall populations treated with Tagrisso, compared to 21.9 and 28.1 months in the primary and overall populations, respectively, treated with placebo. |
| 2022-09-07 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono to Highlight Data at ESMO 2022 with Potential for Transformative Impact on Cancer Patients emdserono.com ↗
Among the 48 patients followed for at least three months, ORR was 45.8% (95% CI, 31.4, 60.8). |
| 2022-08-25 | AstraZeneca | Regulatory Tagrisso approved in Japan for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer astrazeneca.com ↗
AstraZeneca’s Tagrisso (osimertinib) has been approved in Japan for the adjuvant treatment of patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after surgery. |
| 2022-08-08 | Hutchison Medipharma Limited | Results HUTCHMED and AstraZeneca Announce that TAGRISSO® Plus Savolitinib Demonstrated 49% Objective Response Rate in Lung Cancer Patients with High Levels of MET Overexpression and/or Amplification in SAVANNAH Phase II Trial hutch-med.com ↗ |
| 2022-08-08 | AstraZeneca | Results Tagrisso plus savolitinib demonstrated 49% objective response rate in lung cancer patients with high levels of MET overexpression and/or amplification in SAVANNAH Phase II trial astrazeneca.com ↗
Preliminary results from the SAVANNAH Phase II trial showed that Tagrisso (osimertinib) plus savolitinib demonstrated an objective response rate (ORR) of 49% (95% confidence interval [CI], 39-59%) in patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) with high levels of MET overexpression and/or amplification, defined as IHC90+ and/or FISH10+, whose disease progressed on treatment with Tagrisso. |
| 2022-08-01 | Hutchison Medipharma Limited | Results HUTCHMED Reports 2022 Interim Results and Provides Business Updates hutch-med.com ↗
First presentation of SAVANNAH data showing 52% response rate and 9.6 month duration of response in 2L+ post-TAGRISSO® NSCLC1 patients with high MET2 levels and no prior chemotherapy |
| 2022-07-13 | Hutchison Medipharma Limited | Results HUTCHMED Highlights First Presentation of Results of the SAVANNAH Global Phase II Trial of Savolitinib plus TAGRISSO® at the 2022 WCLC Annual Meeting hutch-med.com ↗
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces the first presentation of results from the ongoing SAVANNAH global Phase II trial at the upcoming International Association for the Study of Lung Cancer (IASLC) 2022 World Conference on Lung Cancer (“WCLC”), taking place August 6-9 in Vienna, Austria. |
| 2022-05-27 | Ascentage Pharma Group Inc. | Results ASCO 2022 | Ascentage Pharma Presents Updated Results from Multiple Clinical Studies Demonstrating Rapid Progress in Global Clinical Development ascentage.com ↗
Updated study results of pelcitoclax (APG-1252) in combination with osimertinib in patients (pts) with EGFR-mutant non-small-cell lung cancer (NSCLC). |
| 2021-09-09 | Ascentage Pharma Group Inc. | Results WCLC 2021 | Mini Oral – Ascentage Pharma Announces Latest Data of Its Investigational Bcl-2/Bcl-xL Inhibitor Pelcitoclax (APG-1252) Combined with Osimertinib in Patients with EGFR TKI-Resistant Non-Small Cell Lung Cancer ascentage.com ↗
The data was presented by Prof. Li Zhang, the principal investigator of the study from Sun-Yat Sen University Cancer Center. |
| 2021-08-11 | Revolution Medicines, Inc. | Results Revolution Medicines Reports Second Quarter Financial Results and Update on Corporate Progress revmed.com ↗
To date, the company has not identified a combination dose and schedule with acceptable tolerability, indicating that the combined suppression of RAS signaling in normal tissues caused by these two agents presents too significant a safety hurdle to justify advancing this approach, and no further patients will be enrolled in this study. |
| 2021-06-03 | Zydus Lifesciences Limited | Regulatory Zydus Cadila receives tentative approval from USFDA for Osimertinib Tablets zyduslife.com ↗
Zydus Cadila has received tentative approval from the USFDA to market Osimertinib Tablets in the strengths of 40 mg and 80 mg (US RLD: Tagrisso Tablets). |
| 2021-05-28 | AstraZeneca | Regulatory Tagrisso approved in the EU for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer astrazeneca.com ↗ |
| 2021-04-26 | AstraZeneca | Regulatory Tagrisso recommended for approval in the EU by CHMP for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer astrazeneca.com ↗ |
| 2021-04-14 | AstraZeneca | Regulatory Tagrisso approved in China for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer astrazeneca.com ↗
Tagrisso is the only targeted medicine to show efficacy in the treatment of early-stage lung cancer in a global trial and the first such medicine approved in China |
| 2021-04-12 | Genprex, Inc. | Results Genprex Collaborators Report Positive Preclinical Data for REQORSA™ Immunogene Therapy in Non-Small Cell Lung Cancer at the 2021 AACR Annual Meeting genprex.com ↗
The second poster, entitled “Overcoming resistance to osimertinib by TUSC2 gene therapy in EGFR-mutant NSCLC,” showed that REQORSA in combination with targeted therapy osimertinib (Tagrisso®) demonstrated synergistic antitumor efficacy in EGFR mutant osimertinib resistant NSCLC tumors in H1975-OsiR isogenic tumors. |
| 2021-01-29 | AstraZeneca | Results Tagrisso extended disease-free survival regardless of prior adjuvant chemotherapy in early-stage EGFR-mutated lung cancer astrazeneca.com ↗
DFS benefits were similar across each stage of disease. |
| 2020-12-21 | AstraZeneca | Regulatory Tagrisso approved in the US for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer astrazeneca.com ↗
AstraZeneca’s Tagrisso (osimertinib) has been approved in the US for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumour resection with curative intent. |
| 2020-10-20 | AstraZeneca | Regulatory Tagrisso granted Priority Review in the US for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer astrazeneca.com ↗ |
| 2020-09-19 | AstraZeneca | Results Tagrisso reduced the risk of disease recurrence in the brain by 82% in the adjuvant treatment of early-stage EGFR-mutated lung cancer astrazeneca.com ↗
This analysis showed that fewer patients treated with Tagrisso in the adjuvant setting had recurrence events or deaths compared to placebo (11% versus 46%). |
| 2020-09-08 | AstraZeneca | Results AstraZeneca aims to transform cancer treatment and advance clinical practice with data presented at ESMO 2020 astrazeneca.com ↗
Exploratory data from the ADAURA Phase III trial showing further support for the unprecedented patient benefit of Tagrisso (osimertinib) in the adjuvant treatment of epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) also presented in a Presidential Symposium |
| 2020-09-02 | Boehringer Ingelheim | Results Final analysis of the observational GioTag study: Sequential afatinib and osimertinib in patients with EGFR mutation-positive non-small cell lung cancer prnewswire.com ↗
Results showed that Asian and Del19-positive patients saw a median OS of 44.8 months (90% CI: 37.0–57.8) and 41.6 months (90% CI: 36.9–45.0) respectively. |
| 2020-08-10 | Boehringer Ingelheim | Results Additional analysis of real-world data confirms sequential Gilotrif® followed by osimertinib provided a median overall survival of nearly four years in U.S.-treated patients with EGFR mutation-positive NSCLC prnewswire.com ↗ |
| 2020-07-30 | AstraZeneca | Regulatory Tagrisso granted Breakthrough Therapy Designation in the US for the adjuvant treatment of patients with Stage IB-IIIA EGFR-mutated lung cancer astrazeneca.com ↗ |
| 2020-05-28 | AstraZeneca | Results Tagrisso demonstrated unprecedented disease-free survival in the adjuvant treatment of Stage IB-IIIA patients with EGFR-mutated lung cancer astrazeneca.com ↗
Phase III ADAURA trial showed treatment with Tagrisso after surgery with curative intent reduced the risk of disease recurrence or death by c. 80% |
| 2020-05-15 | Ascentage Pharma Group Inc. | Results Ascentage Pharma to Present Six Abstracts at 2020 AACR Annual Meeting ascentage.com ↗
In summary, these results suggest that the combination treatment with APG-1252 and chemotherapeutics can overcome acquired resistance to osimertinib and the combination deserves further clinical evaluations. |
| 2020-04-10 | AstraZeneca | Results Tagrisso Phase III ADAURA trial will be unblinded early after overwhelming efficacy in the adjuvant treatment of patients with EGFR-mutated lung cancer astrazeneca.com ↗
ADAURA is the first global trial for an EGFR inhibitor to show statistically significant and clinically meaningful benefit in adjuvant treatment of lung cancer |
| 2020-01-21 | Genprex, Inc. | Regulatory Genprex Receives U.S. FDA Fast Track Designation for Gene Therapy that Targets Lung Cancer genprex.com ↗
the U.S Food and Drug Administration (FDA) has granted Fast Track Designation for Genprex’s Oncoprex™ immunogene therapy in combination with EGFR inhibitor osimertinib |
| 2019-09-30 | AstraZeneca | Results Tagrisso is the only 1st-line treatment for EGFR-mutated non-small cell lung cancer to deliver a median overall survival of more than three years astrazeneca.com ↗
Results showed a statistically significant and clinically meaningful improvement in OS, a key secondary endpoint for Tagrisso versus gefitinib or erlotinib, both of which were previous standard-of-care (SoC) treatments in this setting (HR 0.799 [95% CI, 0.641-0.997], p=0.0462). |
| 2019-09-16 | AstraZeneca | Results AstraZeneca redefines cancer treatment with practice-changing data at ESMO 2019 astrazeneca.com ↗
FLAURA is the first and only global Phase III trial to demonstrate a statistically-significant OS benefit in this setting. |
| 2019-09-04 | AstraZeneca | Regulatory Tagrisso approved in China as a 1st-line treatment for EGFR-mutated non-small cell lung cancer astrazeneca.com ↗
The approval followed the Priority Review Pathway and is based on results from the Phase III FLAURA trial, which were published in The New England Journal of Medicine. |
| 2019-08-09 | AstraZeneca | Results Tagrisso significantly improves overall survival in the Phase III FLAURA trial for 1st-line EGFR-mutated non-small cell lung cancer astrazeneca.com ↗
Tagrisso showed a statistically-significant and clinically-meaningful improvement in OS, a secondary endpoint in the FLAURA Phase III trial, compared with erlotinib or gefitinib both of which were previous standard-of-care (SoC) treatments in this setting. |
| 2019-08-05 | Boehringer Ingelheim | Results Updated real-world data show Gilotrif® followed by osimertinib provided a median overall survival of up to almost four years in patients with EGFR Del19 and T790M mutation-positive NSCLC prnewswire.com ↗
Boehringer Ingelheim today announced updated, interim analysis results from the GioTag study, showing that initiating treatment with afatinib followed by osimertinib provided an overall survival (OS) of almost four years (45.7 months) in patients with Del19-positive tumors. |
| 2019-03-26 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Announces Nine Abstracts To Be Presented at the 2019 American Association for Cancer Research Annual Meeting ascentage.com ↗
Novel FAK/ALK/ROS1 Inhibitor APG-2449 Synergizes with Osimertinib in Preclinical Xenograft Models of EGFR-mutant NSCLC |
| 2018-10-22 | Boehringer Ingelheim | Results Real-world study shows sequencing of Gilotrif® followed by osimertinib delivered a combined median time on treatment of 27.6 months in patients with EGFR mutation-positive NSCLC prnewswire.com ↗
According to the study, the median time on treatment for sequential afatinib and osimertinib was 27.6 months. |
| 2018-10-19 | AstraZeneca | Results New data on mechanisms of acquired resistance after 1st-line Tagrisso in NSCLC support initiation of ORCHARD trial to explore post-progression treatment options astrazeneca.com ↗
AstraZeneca today presented new data on the mechanisms of acquired resistance from the Tagrisso (osimertinib) pivotal Phase III FLAURA trial during an oral late-breaker abstract session at the ESMO 2018 Congress (European Society of Medical Oncology) in Munich, Germany. |
| 2018-08-21 | AstraZeneca | Regulatory Tagrisso approved in Japan for 1st-line treatment of EGFR-mutated non-small cell lung cancer astrazeneca.com ↗
Today’s approval moves the use of Tagrisso to the 1st-line setting, replacing older medicines which, given the high prevalence of the EGFR mutation in Japan, offers an important new treatment option for these patients. |
| 2018-06-08 | AstraZeneca | Regulatory The EU approves Tagrisso for 1st-line treatment of EGFR-mutated non-small cell lung cancer astrazeneca.com ↗
Today the European Commission has granted marketing authorisation for Tagrisso (osimertinib) as monotherapy for the 1st-line treatment of adult patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations. |
| 2018-04-27 | AstraZeneca | Regulatory Tagrisso receives positive EU CHMP opinion for 1st-line treatment of EGFR-mutated non-small cell lung cancer astrazeneca.com ↗
This positive recommendation acknowledges Tagrisso’s potential as a new 1st-line standard of care for patients with EGFR-mutated NSCLC in Europe. |
| 2018-04-18 | AstraZeneca | Regulatory US FDA approves Tagrisso as 1st-line treatment for EGFR-mutated non-small cell lung cancer astrazeneca.com ↗
Today’s FDA approval of Tagrisso in the 1st-line setting is an exciting milestone for patients and our company. |
| 2018-04-13 | AstraZeneca | Results 1st-line Tagrisso demonstrates sustained benefit post progression in patients with EGFR-mutated non-small cell lung cancer astrazeneca.com ↗
The new analysis from the FLAURA trial shows that 1st-line treatment with Tagrisso has a sustained effect beyond subsequent therapy by almost halving the risk of a second progression or death. |
| 2018-04-04 | AstraZeneca | Results AstraZeneca’s early and late-stage oncology portfolio showcased at AACR annual meeting and ELCC astrazeneca.com ↗
In addition, patient-reported outcomes data will also be presented from the FLAURA trial, showing improvements in key symptoms, supporting the potential use of Tagrisso in this setting (Abstract #139PD). |
| 2017-12-18 | AstraZeneca | Regulatory US FDA accepts regulatory submission for Tagrisso in 1st-line EGFR-mutated non-small cell lung cancer astrazeneca.com ↗ |
| 2017-11-28 | AstraZeneca | Regulatory The European Medicines Agency accepts regulatory submission for Tagrisso in 1st-line EGFR-mutated non-small cell lung cancer astrazeneca.com ↗
AstraZeneca today announced that the European Medicines Agency has accepted a variation to the Marketing Authorisation Application (MAAv) for Tagrisso (osimertinib) |
| 2017-11-27 | AstraZeneca | Regulatory AstraZeneca makes regulatory submission for Tagrisso in 1st-line EGFR-mutated non-small cell lung cancer in Japan astrazeneca.com ↗ |
| 2017-10-17 | Hutchison Medipharma Limited | Results Chi-Med and AstraZeneca’s Savolitinib Shows Encouraging Clinical Activity in Second-Line EGFR Mutation-Positive Lung Cancer with MET-Amplification hutch-med.com ↗
In both trials, the addition of savolitinib (600mg, once daily), an investigational selective inhibitor of mesenchymal epithelial transition factor (“c-MET”) receptor tyrosine kinase, to Tagrisso® (80mg, once daily) or Iressa® (250mg, once daily) demonstrated preliminary anti-tumor activity. |
| 2017-10-09 | AstraZeneca | Regulatory Tagrisso granted breakthrough therapy designation by US FDA for the 1st-line treatment of patients with EGFR mutation-positive non-small cell lung cancer astrazeneca.com ↗
AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). |
| 2017-09-08 | AstraZeneca | Results AstraZeneca’s Tagrisso shows potential as a new standard of care in 1st-line EGFR-mutated lung cancer at ESMO 2017 Congress astrazeneca.com ↗
The FLAURA data suggest early and sustained benefit with Tagrisso that has the potential to significantly impact long-term patient outcomes and help address the considerable unmet need that remains. |
| 2017-08-31 | AstraZeneca | Results AstraZeneca highlights latest advances in lung cancer at the ESMO 2017 Congress astrazeneca.com ↗
Phase III FLAURA results highlight superiority of Tagrisso over standard of care in previously-untreated patients with advanced EGFRm NSCLC |
| 2017-07-27 | AstraZeneca | Results Tagrisso significantly improves progression-free survival in the Phase III FLAURA trial for lung cancer astrazeneca.com ↗ |
| 2017-05-18 | Hutchison Medipharma Limited | Results Chi-Med Presents Clinical Data at ASCO 2017 Annual Meeting hutch-med.com ↗
3 patients received combination Tagrisso®/savolitinib therapy; all 3 had partial response (“PR”) under RECIST (Response Evaluation Criteria in Solid Tumors) guidelines. |
| 2017-04-25 | AstraZeneca | Regulatory Tagrisso receives full approval in the EU astrazeneca.com ↗
AstraZeneca today announced that the European Commission (EC) has granted full marketing authorisation for Tagrisso (osimertinib) 40mg and 80mg once-daily tablets for the treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC). |
| 2017-03-31 | AstraZeneca | Regulatory Tagrisso (osimertinib) receives US FDA full approval astrazeneca.com ↗ |
| 2017-03-27 | AstraZeneca | Regulatory Tagrisso approved in China as first-in-class treatment for EGFR T790M mutation-positive metastatic non-small cell lung cancer astrazeneca.com ↗
AstraZeneca today announced that the China Food and Drug Administration (CFDA) has granted marketing authorisation for Tagrisso (osimertinib) 40 mg and 80mg once-daily oral tablets for the treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. |
| 2016-12-06 | AstraZeneca | Results Tagrisso demonstrates superiority over chemotherapy in EGFR T790M mutation-positive non-small cell lung cancer astrazeneca.com ↗
The first randomised Phase III data showed that Tagrisso 2nd-line therapy improved progression-free survival (PFS) by 5.7 months compared with standard platinum-based doublet chemotherapy (Hazard Ratio [HR]=0.3). |
| 2016-07-18 | AstraZeneca | Results Tagrisso met primary endpoint in phase III 2nd-line lung cancer trial astrazeneca.com ↗
AstraZeneca today announced that the Phase III AURA3 trial met its primary endpoint, demonstrating superior progression-free survival (PFS) compared to standard platinum-based doublet chemotherapy. |
| 2016-03-29 | AstraZeneca | Regulatory Tagrisso™ (osimertinib) approved in Japan for patients with EGFR T790M mutation-positive metastatic non-small cell lung cancer astrazeneca.com ↗ |
| 2016-02-03 | AstraZeneca | Regulatory TAGRISSO™ (osimertinib) approved in EU as first-in-class treatment for patients with EGFR T790M mutation-positive metastatic non-small cell lung cancer astrazeneca.com ↗
Osimertinib is indicated for patients with T790M mutation-positive NSCLC, irrespective of previous treatment with an EGFR tyrosine kinase inhibitor (TKI). |
| 2015-12-18 | AstraZeneca | Regulatory TAGRISSO™ (osimertinib) receives positive CHMP opinion for patients with EGFR T790M mutation-positive metastatic non-small cell lung cancer astrazeneca.com ↗ |
| 2015-11-13 | AstraZeneca | Regulatory TAGRISSO™ (AZD9291) approved by the US FDA for patients with EGFR T790M mutation-positive metastatic non-small cell lung cancer astrazeneca.com ↗
This indication is approved under the FDA’s accelerated approval process based on tumour response rate and duration of response (DoR). |
| 2015-09-24 | AstraZeneca | Results AstraZeneca presents advances in oncology research at ECC 2015 with data on AZD9291, durvalumab and LYNPARZA™ (olaparib) astrazeneca.com ↗
An analysis of AURA Phase II studies (Abstract # 3083) will demonstrate the consistent activity of AZD9291 in patients with EGFRm T790M NSCLC with and without brain metastases; clinical anecdotes suggest that AZD9291 may have activity in the brain. |
| 2015-06-02 | AstraZeneca | Results AstraZeneca updates on immuno-oncology combinations development programme at the 2015 ASCO Annual Meeting astrazeneca.com ↗
MEDI4736 and AZD9291 - early data indicates the molecules are well tolerated in combination at their Phase III doses, providing early promise of a potential new standard of care in EGFR mutation (EGFRm) and T790M positive NSCLC. |
| 2015-05-30 | AstraZeneca | Results AstraZeneca and MedImmune present positive immuno-oncology combination data at the 2015 ASCO Annual Meeting astrazeneca.com ↗
Preliminary results from TATTON, a multi-arm Phase Ib trial of AZD9291 combined with MEDI4736, AZD6094 or selumetinib in EGFR-mutant lung cancer patients who have progressed following therapy with an EGFR-TKI, indicated that MEDI4736 and AZD9291 were tolerated at their Phase III doses in the combination arm. |
| 2015-04-17 | AstraZeneca | Results AstraZeneca announces updated progression free survival data for investigational non-small cell lung cancer medicine AZD9291 astrazeneca.com ↗ |
| 2015-04-13 | AstraZeneca | Results AstraZeneca to showcase strong oncology science at American Association for Cancer Research Annual Meeting 2015 astrazeneca.com ↗ |
| 2014-06-03 | AstraZeneca | Results AstraZeneca updates on the rapid progress of its oncology pipeline at ASCO 2014 astrazeneca.com ↗
94% of T790M positive (T790M+) patients saw their tumours shrink or become stable. |
| 2014-05-15 | AstraZeneca | Results Continuing progress in accelerating late stage pipeline reinforces confidence in AstraZeneca’s strategy as an independent company astrazeneca.com ↗
Data from the large Phase I study of AZD9291 suggest it is well tolerated and clinically active in patients with EGFR mutation positive (EGFRm+) non-small cell lung cancer (NSCLC) who have developed acquired resistance to EGFR tyrosine-kinase inhibitors (TKIs). |
| 2014-05-14 | AstraZeneca | Results AstraZeneca to demonstrate the strength and rapid acceleration of its oncology pipeline at ASCO 2014 astrazeneca.com ↗
Data from the large Phase I study of AZD9291 has shown that it was well tolerated and clinically active in patients with EGFR mutation positive (EGFRm+) non-small cell lung cancer (NSCLC) who have developed acquired resistance to EGFR tyrosine-kinase inhibitors (TKIs). |
All press releases naming this drug 168 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 168 releases opens the full record — a long page | ||
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 294 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | osimertinib | “OBJECTIVES: Reliable epidermal growth factor receptor (EGFR) mutation testing techniques are required to identify eligible patients with EGFR mutation/T790M positive advanced...” PMID 28577957 ↗ Apr 2017260“AZD9291 (osimertinib) is a potent irreversible inhibitor of both the single epidermal growth factor receptor sensitising mutation positive (EGFRm+) (tyrosine kinase inhibitor...” NCT02143466 ↗ “The microdevices will dwell in the tumor tissue for a time window of 2-4 hours to allow time for tissue effects of the drugs (Temozolomide, Lomustine, Irinotecan, Carboplatin,...” NCT04135807 ↗ “A phase I/II, open-label, multicentre study to investigate the safety, tolerability, pharmacokinetics and anti-tumour activity of AZD4205 as monotherapy or in combination with...” NCT03450330 ↗ “Osimertinib is a potent, third-generation, irreversible, central nervous system active epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) that selectively...” PMID 30875094 ↗ Mar 2019 “Osimertinib is a third-generation, central nervous system-active, epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) selective for EGFR-TKI sensitizing and...” PMID 29683562 ↗ Apr 2018 “Osimertinib (AZD9291) is an oral, potent, irreversible EGFR tyrosine-kinase inhibitor selective for EGFR tyrosine-kinase inhibitor sensitising mutations, and the EGFR Thr790Met...” PMID 27751847 ↗ Oct 2016 “Osimertinib (TAGRISSO®) is a medication used to treat a type of NSCLC with a change (mutation) in the EGFR gene, known as EGFR-mutated NSCLC.” PMID 34723634 ↗ Nov 2021 “All patients receive first-line oral therapy with standard-dose third-generation EGFR-TKIs (osimertinib, aumolertinib, or furmonertinib).” NCT07637448 ↗ “Osimertinib, an epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI), undergoes significant hepatic elimination.” PMID 30872388 ↗ Mar 2019 “Osimertinib is an oral, third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI)” PMID 29151359 ↗ Nov 2017 |
| Known as | AZD9291 | “AZD9291 (osimertinib) is a potent irreversible inhibitor of both the single epidermal growth factor receptor sensitising mutation positive (EGFRm+) (tyrosine kinase inhibitor...” NCT02143466 ↗35“Osimertinib (AZD9291) is an oral, potent, irreversible EGFR tyrosine-kinase inhibitor selective for EGFR tyrosine-kinase inhibitor sensitising mutations, and the EGFR Thr790Met...” PMID 27751847 ↗ Oct 2016 “Osimertinib, also known as azd9291, is a 3rd-generation EGFR-TKI used to treat NSCLC patients with resistance to 1st generation EGFR-TKI due to T790M mutation.” NCT03543683 ↗ “Osimertinib, also known as azd9291, is a 3rd-generation EGFR-TKI used to treat NSCLC patients with resistance to 1st generation EGFR-TKI due to T790M mutation.” NCT04184921 ↗ “Osimertinib (AZD9291) is a novel oral, potent, and selective third-generation irreversible inhibitor of both EGFRm-sensitizing and T790M resistance mutants.” NCT03133546 ↗ “Osimertinib, (AZD9291, Tagrisso, AstraZeneca) is a third-generation EGFRTKI” NCT04811001 ↗ “AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy” NCT02151981 ↗ “Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin” NCT04765059 ↗ “osimertinib (AZD9291) and bevacizumab” NCT04181060 ↗ “Osimertinib; AZD9291” NCT02923947 ↗ |
| Known as | Osi | “Participants will receive increasing doses of telisotuzumab adizutecan with osimertinib (Osi), as part of the approximately 76 month study duration.” NCT07005102 ↗ |
| Known as | Osimertinib mesylate | “osimertinib mesylate tablets 80mg qd and anlotinib hydrochloride capsules 10mg qd day 1-14 of a 21-day cycle” NCT04438902 ↗6“Osimertinib mesylate is a third-generation epidermal growth factor receptor inhibitor.” NCT05284994 ↗ “Study Drug: Osimertinib mesylate tablets (Tagrisso®).” NCT07505173 ↗ “Generic name: Osimertinib mesylate” NCT06530719 ↗ “Osimertinib mesylate tablets.” NCT06895928 ↗ “Osimertinib Mesylate Tablets” NCT06970639 ↗ “Osimertinib Mesylate Tablets” NCT06908772 ↗ |
| Known as | Osimertinib Mesylate Tablets | “Drug: Osimertinib Mesylate Tablets” NCT05132777 ↗ |
| Known as | TAGRISSO | “Purpose: The mechanisms accounting for anticancer activity of AZD9291 (osimertinib or TAGRISSO), an approved third-generation EGFR inhibitor, in EGFR-mutant non-small cell lung...” PMID 28765329 ↗ Aug 201710“Osimertinib (TAGRISSO®) is a medication used to treat a type of NSCLC with a change (mutation) in the EGFR gene, known as EGFR-mutated NSCLC.” PMID 34723634 ↗ Nov 2021 “Oral administration of TAGRISSO® 80mg (Osimertinib) as a single daily dose until disease progression or unacceptable toxicity.” NCT03865511 ↗ “Osimertinib (TAGRISSO, AZD9291) has been recommended in EGFR-mutant advanced NSCLC patients as first-line treatment.” PMID 36333268 ↗ Sep 2022 “TAGRISSO (Osimertinib) in NSCLC Patients in Whom T790 Mutations Are Detected by Liquid Biopsy” NCT03394118 ↗ “comparing Tagrisso (osimertinib) with platinum-based chemotherapy” PMID 35575012 ↗ May 2022 “Study Drug: Osimertinib mesylate tablets (Tagrisso®).” NCT07505173 ↗ “Drug: Osimertinib 80 MG [Tagrisso]” NCT03414814 ↗ “Osimertinib (Tagrisso®)” NCT07206498 ↗ |
| Action | Inhibit | “potently and selectively inhibits both EGFR sensitizing mutation and EGFR T790M” PMID 31345012 ↗ Jul 2019 |
| Modality | Small molecule | “third-generation, irreversible, oral epidermal growth factor receptor-TKI” PMID 33939068 ↗ May 2021 |
| Route | Oral | “Daily oral dose of AZD9291” NCT01802632 ↗ |
| Target | EGFR | “potently and selectively inhibits both EGFR sensitizing mutation and EGFR T790M” PMID 31345012 ↗ Jul 2019 |