Drugs / Gefitinib
last change 8 days ago re-read 2 minutes ago

Gefitinib

Small molecule targets EGFR via inhibition

Developed for
non-small cell lung carcinoma · lung cancer · head and neck cancer · breast cancer · colorectal cancer · esophageal cancer · lung adenocarcinoma · prostate cancer
+114 more · cancer · fallopian tube cancer · metastatic malignant neoplasm in the brain · ovarian cancer · squamous cell carcinoma · central nervous system neoplasm · giant cell glioblastoma · glioblastoma · kidney cancer · lung large cell carcinoma · urinary bladder cancer · adenosquamous lung carcinoma · adult glioblastoma · breast neoplasm · cancer of unknown primary site · female breast carcinoma · gallbladder cancer · gliosarcoma · head and neck squamous cell carcinoma · hypopharynx squamous cell carcinoma · metastatic carcinoma · neoplasm · neuroblastoma · oropharynx squamous cell carcinoma · osteosarcoma · primary peritoneal carcinoma · renal pelvis/ureter urothelial carcinoma · salivary gland cancer · skin cancer · squamous cell lung carcinoma · ACTH-producing pituitary gland adenoma · acute leukemia of ambiguous lineage · acute lymphoblastic leukemia · acute myeloid leukemia · adenoid cystic carcinoma · adrenal cortex carcinoma · adult hepatocellular carcinoma · anaplastic astrocytoma · anaplastic oligodendroglioma · brain neoplasm · carcinoma of lip · cervical cancer · childhood brain stem glioma · childhood malignant neoplasm · childhood oligodendroglioma · cholangiocarcinoma · colon mucinous adenocarcinoma · colon signet ring cell adenocarcinoma · Cushing disease due to pituitary adenoma · digestive system cancer · esthesioneuroblastoma · estrogen-receptor positive breast cancer · extrahepatic bile duct carcinoma · gastric cancer · gastric neoplasm · gastrin-producing neuroendocrine tumor · gliomatosis cerebri · glucagonoma · head and neck neoplasm · hepatocellular carcinoma · inverted papilloma · laryngeal squamous cell carcinoma · larynx verrucous carcinoma · lip and oral cavity squamous cell carcinoma · liver cancer · lung neoplasm · lymphoepithelial-like carcinoma · male breast carcinoma · malignant germ cell tumor · malignant pancreatic neoplasm · medullary thyroid gland carcinoma · mesothelioma · metastatic malignant neoplasm · metastatic neoplasm · metastatic squamous cell carcinoma · microinvasive gastric cancer · nasal cavity and paranasal sinus lethal midline granuloma · nasal cavity and paranasal sinus squamous cell carcinoma · nasopharyngeal carcinoma · nasopharyngeal squamous cell carcinoma · oral cavity mucoepidermoid carcinoma · ovarian carcinoma · pancreatic cholera · pancreatic endocrine carcinoma · pancreatic insulinoma · parathyroid gland carcinoma · peritoneal carcinoma · peritoneal neoplasm · peritoneum cancer · poorly differentiated thyroid gland carcinoma · PPoma · progesterone-receptor positive breast cancer · rectal signet ring cell adenocarcinoma · rectum mucinous adenocarcinoma · refractory malignant neoplasm · renal cell carcinoma · rhabdomyosarcoma · sarcoma · sarcomatoid mesothelioma · skin squamous cell carcinoma · small cell lung carcinoma · somatostatinoma · thyroid gland papillary carcinoma · thyroid gland undifferentiated (anaplastic) carcinoma · tongue carcinoma · undifferentiated carcinoma of nasopharynx · urethra cancer · urothelial carcinoma · uterine carcinoma · verrucous carcinoma of oral cavity · adenocarcinoma · bladder transitional cell carcinoma · hormone-resistant prostate carcinoma · neoplasm of thorax
Investigated by
AstraZeneca · National Cancer Institute (NCI) · Massachusetts General Hospital · Memorial Sloan Kettering Cancer Center · Sun Yat-sen University · Dana-Farber Cancer Institute
+198 more · European Organisation for Research and Treatment of Cancer - EORTC · Fudan University · M.D. Anderson Cancer Center · Samsung Medical Center · University of Chicago · Brigham and Women's Hospital · Eli Lilly and Company · Peking Union Medical College Hospital · Ruijin Hospital · Guangdong Association of Clinical Trials · H. Lee Moffitt Cancer Center and Research Institute · Huashan Hospital · National Cancer Center, Korea · Peking University Cancer Hospital & Institute · RenJi Hospital · Shanghai Chest Hospital · Shanghai Pulmonary Hospital, Shanghai, China · St. Jude Children's Research Hospital · Stanford University · The First Affiliated Hospital of Soochow University · Alliance for Clinical Trials in Oncology · Asan Medical Center · Aventis Pharmaceuticals · Barbara Ann Karmanos Cancer Institute · Baylor Breast Care Center · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Case Comprehensive Cancer Center · Changhai Hospital · China Medical University Hospital · Chinese PLA General Hospital · Eastern Hepatobiliary Surgery Hospital · French Cooperative Thoracic Intergroup · Fujian Cancer Hospital · Guangdong Provincial People's Hospital · Gynecologic Oncology Group · Henan Cancer Hospital · Hutchison Medipharma Limited · IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy · Jiangsu Cancer Institute & Hospital · Merck KGaA, Darmstadt, Germany · Merck Sharp & Dohme LLC · Nanchang University · National Cancer Centre, Singapore · National Institutes of Health (NIH) · National Taiwan University Hospital · National University Hospital, Singapore · Novartis · Novartis Pharmaceuticals · Qilu Hospital of Shandong University · Qilu Pharmaceutical Co., Ltd. · Roswell Park Cancer Institute · SCRI Development Innovations, LLC · Sanofi · Second Affiliated Hospital of Nanchang University · Shanghai Jiao Tong University School of Medicine · Shenzhen People's Hospital · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Tang-Du Hospital · The University of Texas Health Science Center at San Antonio · Tianjin Medical University Cancer Institute and Hospital · Wu Jieping Medical Foundation · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Yonsei University · Zhejiang Cancer Hospital · 309th Hospital of Chinese People's Liberation Army · AGO Study Group · AIO-Studien-gGmbH · ASL TO4, Chivasso · Affiliated Hospital of Jiangnan University · American Society of Clinical Oncology · Amsterdam UMC, location VUmc · Anhui Medical University · Azienda Ospedaliera "Sant'Andrea" · Azienda Ospedaliera S. Maria della Misericordia · all 204 on the full record

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Iressa 2009-06-24 europa.eu
Approved US (FDA) IRESSA 2003-05-05 fda.gov

Trials 282 · started per year

today
US approved 2003
EU approved 2009
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT07458919 Mar 2026 → Oct 2030 expected lung cancer Fuzhou General Hospital Not yet recruiting No outcome recorded
Phase 129 trials
Phase 1 NCT04390984 May 2020 → Feb 2021 non-small cell lung carcinoma Jiangsu HengRui Medicine Co., Ltd. Unknown No outcome recorded
Phase 1 NCT03599518 Sep 2018 → Apr 2020 non-small cell lung carcinoma Daiichi Sankyo Terminated No outcome recorded
Phase 1 NCT03333343 Jan 2018 → Oct 2026 expected non-small cell lung carcinoma Novartis Pharmaceuticals Active not recruiting No outcome recorded
Phase 1 NCT02374645 Apr 2015 → Feb 2018 non-small cell lung carcinoma Hutchison Medipharma Limited Completed No outcome recorded
Phase 1 NCT02151721 Jun 2014 → Feb 2018 non-small cell lung carcinoma Kanazawa University Unknown No outcome recorded
Phase 1 NCT02088112 Mar 2014 → Mar 2021 non-small cell lung carcinoma MedImmune LLC Completed No outcome recorded
Phase 1 NCT02040064 Jan 2014 → Mar 2016 non-small cell lung carcinoma Gustave Roussy, Cancer Campus, Grand Paris Completed No outcome recorded
Phase 1 NCT01570296 Oct 2011 → Feb 2016 non-small cell lung carcinoma National Cancer Centre, Singapore Completed No outcome recorded
Phase 1 NCT00497250 Jul 2007 → Mar 2009 non-small cell lung carcinoma Fudan University Unknown No outcome recorded
Phase 1 NCT00372515 Jun 2006 → Dec 2012 non-small cell lung carcinoma David M. Jackman, MD Completed No outcome recorded
Phase 1/231 trials
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 NCT03122717 May 2017 → Oct 2026 expected non-small cell lung carcinoma Dana-Farber Cancer Institute Active not recruiting No outcome recorded
Phase 1/2 NCT03758287 Nov 2016 → Sep 2021 non-small cell lung carcinoma Sunshine Lake Pharma Co., Ltd. Completed No outcome recorded
Phase 1/2 NCT02039674 Feb 2014 → Nov 2016 non-small cell lung carcinoma Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1/2 NCT01982955 Dec 2013 → Dec 2017 non-small cell lung carcinoma Merck KGaA, Darmstadt, Germany Completed No outcome recorded
Phase 1/2 NCT01513174 Aug 2011 → Jul 2016 non-small cell lung carcinoma Spanish Lung Cancer Group Completed No outcome recorded
Phase 1/2 NCT01027676 Jun 2010 → Dec 2013 non-small cell lung carcinoma National Cancer Center, Korea Unknown No outcome recorded
Phase 1/2 NCT00809237 Nov 2008 → Nov 2014 non-small cell lung carcinoma National University Hospital, Singapore Unknown No outcome recorded
Phase 1/2 NCT00423397 Sep 2006 → Jan 2008 skin cancer University of California, San Diego Unknown No outcome recorded
Phase 1/2 NCT00352105 Apr 2006 → Sep 2008 head and neck cancer David Adelstein Completed No outcome recorded
Phase 2160 trials
Phase 2 NCT07477457 Mar 2026 → Mar 2028 expected metastatic neoplasm, osteosarcoma Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 2 NCT04358562 May 2020 → May 2022 non-small cell lung carcinoma Second Affiliated Hospital of Nanchang University Unknown No outcome recorded
Phase 2 NCT04193007 Dec 2019 → Dec 2021 metastatic malignant neoplasm in the brain, non-small cell lung carcinoma Second Affiliated Hospital of Nanchang University 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 NCT03720873 Oct 2018 → Jun 2021 Fujian Cancer Hospital Unknown No outcome recorded
Phase 2 NCT03486496 Jun 2018 → Jun 2019 lung adenocarcinoma Fujian Cancer Hospital Unknown No outcome recorded
Phase 2 NCT03457337 Mar 2018 → Oct 2020 Henan Cancer Hospital Unknown No outcome recorded
Phase 2 NCT03382795 Jan 2018 → Mar 2023 non-small cell lung carcinoma Korea University Guro Hospital Unknown No outcome recorded
Phase 2 NCT03292133 Oct 2017 → Dec 2021 lung cancer Massachusetts General Hospital Terminated No outcome recorded
Phase 2 NCT03267654 Oct 2017 → Oct 2020 non-small cell lung carcinoma Qilu Pharmaceutical Co., Ltd. Unknown No outcome recorded
Show all 160 trials opens the full record — a long page
Phase 2/36 trials
Phase 2/3 NCT02326285 Nov 2015 → Mar 2017 non-small cell lung carcinoma AIO-Studien-gGmbH Terminated No outcome recorded
Phase 2/3 NCT02338011 Nov 2014 → Nov 2017 metastatic malignant neoplasm in the brain, non-small cell lung carcinoma Shanghai Chest Hospital Unknown No outcome recorded
Phase 2/3 NCT01579630 Mar 2011 → Jun 2013 non-small cell lung carcinoma Taipei Veterans General Hospital, Taiwan Unknown No outcome recorded
Phase 2/3 NCT01769066 Dec 2009 → Feb 2014 non-small cell lung carcinoma Fudan University Completed No outcome recorded
Phase 2/3 NCT00259064 Sep 2004 → Feb 2007 non-small cell lung carcinoma AstraZeneca Completed No outcome recorded
Phase 2/3 NCT00234429 Nov 2003 → Jun 2006 colorectal cancer AstraZeneca Completed No outcome recorded
Phase 335 trials
Phase 3 NCT04143607 Jul 2019 → Mar 2024 overdue Jiangsu Aosaikang Pharmaceutical Co., Ltd. Active not recruiting No outcome recorded
Phase 3 NCT03656393 Aug 2018 → Jul 2020 non-small cell lung carcinoma Shenzhen People's Hospital Unknown No outcome recorded
Phase 3 NCT03381066 Apr 2018 → Dec 2022 Yonsei University Unknown No outcome recorded
Phase 3 NCT03203590 Sep 2017 → Jan 2026 Sun Yat-sen University Unknown No outcome recorded
Phase 3 NCT02929693 Oct 2016 → Jun 2019 cancer Shanghai University of Traditional Chinese Medicine Unknown No outcome recorded
Phase 3 NCT02859077 Aug 2016 → Jul 2017 non-small cell lung carcinoma Shanghai Pulmonary Hospital, Shanghai, China Unknown No outcome recorded
Phase 3 NCT01951469 Jan 2016 → Jun 2022 metastatic malignant neoplasm in the brain, non-small cell lung carcinoma Sun Yat-sen University Unknown No outcome recorded
Phase 3 NCT02714010 Aug 2015 → Dec 2021 non-small cell lung carcinoma Sun Yat-sen University Unknown No outcome recorded
Phase 3 NCT02411448 May 2015 → Jan 2019 overdue non-small cell lung carcinoma Eli Lilly and Company Active not recruiting No outcome recorded
Phase 3 NCT02518802 Jan 2015 → Jan 2018 lung neoplasm Tang-Du Hospital Unknown No outcome recorded
Phase 47 trials
Phase 4 NCT03264794 Aug 2017 → Dec 2021 non-small cell lung carcinoma Jiangsu Famous Medical Technology Co., Ltd. Unknown No outcome recorded
Phase 4 NCT02299765 Dec 2014 → Oct 2017 non-small cell lung carcinoma Sichuan University Terminated No outcome recorded
Phase 4 NCT02031601 Jan 2014 → Dec 2016 non-small cell lung carcinoma Qilu Hospital of Shandong University Unknown No outcome recorded
Phase 4 NCT01203917 Sep 2010 → Aug 2012 AstraZeneca Completed No outcome recorded
Phase 4 NCT00770588 Sep 2008 → Jan 2011 non-small cell lung carcinoma AstraZeneca Completed No outcome recorded
Phase 4 NCT00536107 Oct 2007 → Aug 2009 non-small cell lung carcinoma AstraZeneca Terminated No outcome recorded
Phase 4 NCT00608868 Jan 2007 → Jan 2009 non-small cell lung carcinoma AstraZeneca Completed No outcome recorded
Phase not applicable11 trials
NCT04642547 Dec 2020 → Mar 2023 hepatocellular carcinoma RenJi Hospital Completed No outcome recorded
NCT03766490 Mar → Dec 2019 non-small cell lung carcinoma The First Affiliated Hospital of Soochow University Unknown No outcome recorded
NCT03381430 Jun 2018 → Mar 2023 lung cancer Qilu Pharmaceutical Co., Ltd. Unknown No outcome recorded
NCT03258671 Oct 2017 → Dec 2020 non-small cell lung carcinoma LuBing Unknown No outcome recorded
NCT02551718 Sep 2015 → Jun 2020 acute leukemia of ambiguous lineage, acute lymphoblastic leukemia University of Washington Completed No outcome recorded
NCT02282267 Oct 2014 → Dec 2017 lung adenocarcinoma Peking University Cancer Hospital & Institute Unknown No outcome recorded
NCT02148380 May → Dec 2014 non-small cell lung carcinoma Baohui Han Completed No outcome recorded
NCT02013089 Dec 2013 → May 2017 digestive system cancer Sun Yat-sen University Unknown No outcome recorded
NCT03157310 May 2009 → May 2013 non-small cell lung carcinoma Qilu Hospital of Shandong University Completed No outcome recorded
NCT00104728 Oct 2004 → May 2008 lung cancer H. Lee Moffitt Cancer Center and Research Institute Terminated No outcome recorded
Phase not stated2 trials
NCT00683306 non-small cell lung carcinoma AstraZeneca Approved for marketing No outcome recorded
NCT00684385 head and neck cancer, non-small cell lung carcinoma AstraZeneca Approved for marketing No outcome recorded
Also used as a comparator or background therapy in 67 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 18 trials
Phase 1 NCT07271446 Background Sep 2018 → Aug 2019 non-small cell lung carcinoma Precision Biotech Taiwan Corp. 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 NCT02321293 Background Aug 2015 → Aug 2016 lung cancer Lady Davis Institute Unknown No outcome recorded
Phase 1 NCT01602289 Background Jun 2012 → Aug 2014 lymphoma, non-small cell lung carcinoma Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT01147211 Background Sep 2010 → Jul 2013 non-small cell lung carcinoma National Taiwan University Hospital Unknown No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT03799094 Background Dec 2018 → Dec 2020 non-small cell lung carcinoma Clifford Hospital, Guangzhou, China Unknown No outcome recorded
Phase 1/2 NCT02906163 Background Oct 2016 → Dec 2019 lung cancer SciClone Pharmaceuticals Unknown No outcome recorded
Phase 1/2 NCT01039948 Comparator Dec 2009 → Aug 2013 non-small cell lung carcinoma AVEO Pharmaceuticals, Inc. Completed No outcome recorded
Phase 225 trials
Phase 2 NCT04425187 Comparator Jun 2020 → Dec 2021 Fudan University Unknown No outcome recorded
Phase 2 NCT03389256 Background Dec 2018 → Dec 2020 non-small cell lung carcinoma Sichuan Cancer Hospital and Research Institute Unknown No outcome recorded
Phase 2 NCT03461185 Background May 2018 → Aug 2019 non-small cell lung carcinoma Xinqiao Hospital of Chongqing Unknown No outcome recorded
Phase 2 NCT03119519 Background Dec 2017 → Sep 2020 non-small cell lung carcinoma Southern Medical University, China Unknown No outcome recorded
Phase 2 NCT03123484 Background Apr 2017 → Apr 2019 non-small cell lung carcinoma China Medical University, China Unknown No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT03653546 Comparator Oct 2018 → Jul 2022 metastatic malignant neoplasm in the brain, non-small cell lung carcinoma Alpha Biopharma (Jiangsu) Co., Ltd. Completed No outcome recorded
Phase 2/3 NCT02387086 Background May 2015 → May 2017 non-small cell lung carcinoma Bai Jun Unknown No outcome recorded
Phase 321 trials
Phase 3 NCT03866499 Comparator Apr 2021 → Nov 2023 overdue non-small cell lung carcinoma Beta Pharma Shanghai Active not recruiting No outcome recorded
Phase 3 NCT04248829 Comparator Feb 2020 → Jul 2022 non-small cell lung carcinoma Yuhan Corporation Completed No outcome recorded
Phase 3 NCT04239833 Comparator Jan 2020 → Jan 2022 non-small cell lung carcinoma Nanjing Sanhome Pharmaceutical, Co., Ltd. Unknown No outcome recorded
Phase 3 NCT03787992 Comparator May 2019 → Sep 2021 overdue Allist Pharmaceuticals, Inc. Active not recruiting No outcome recorded
Phase 3 NCT04028778 Background Apr 2019 → Dec 2020 non-small cell lung carcinoma Sun Yat-sen University Unknown No outcome recorded
Phase 41 trial
Phase 4 NCT04401059 Comparator Nov 2020 → Sep 2025 adenocarcinoma, non-small cell lung carcinoma Tian Xie Unknown No outcome recorded
Phase not applicable7 trials
NCT04007835 Background Jul 2019 → Jul 2021 non-small cell lung carcinoma Guangdong Association of Clinical Trials Unknown No outcome recorded
NCT03602027 Background Aug → Dec 2018 non-small cell lung carcinoma Second Affiliated Hospital of Nanchang University Unknown No outcome recorded
NCT03071705 Background Mar 2016 → Apr 2017 lung adenocarcinoma National Cancer Institute of Mexico Unknown No outcome recorded
NCT02701231 Background Nov 2015 → Dec 2020 lung cancer Chinese PLA General Hospital Unknown No outcome recorded
NCT02208583 Comparator Jun 2014 → Dec 2016 hormone-resistant prostate carcinoma Tianjin Medical University Cancer Institute and Hospital Unknown No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2019-07-02 Novartis Pharmaceuticals Sandoz launches oncology generic gefitinib in 13 EU countries at loss of market exclusivity, expanding access to essential medicine novartis.com

Evidence & citations 17 cited values

Every value below carries the sentence it was read from. 357 sources stand behind the page.

FieldValueCited text
Known as gefitinib “Participants with epidermal growth factor receptor (EGFR) gene mutation will receive a drug called Gefitinib, which inhibits a protein called EGFR that is thought to be a key...” NCT02208583
308

“This is a phase I study of MK2206 (an AKT inhibitor)and gefitinib in nonsmall cell lung cancer patients who failed prior chemotherapy and epidermal growth factor...” NCT01147211

“Patients were randomly allocated to receive EGFR-TKIs (erlotinib hydrochloride, afatinib dimaleate, or gefitinib at standard dosage) plus metformin hydrochloride (500 mg twice...” PMID 31486833 Nov 2019

“The purpose of this protocol is to estimate the maximum tolerated dose of gefitinib in combination with fixed dose of irinotecan and vincristine in patients with refractory...” NCT00186979

“This study aims to determine effectiveness of Gefitinib (Iressa) in recurrent glioblastoma after standard treatment (surgery, radiationtherapy and at least a first line chemotherapy).” NCT00250887

Gefitinib is an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) that has been widely used for the treatment of non-small cell lung cancer (NSCLC).” PMID 22237124 Jan 2012

“Combination Anastrozole-ZD1839 (Gefitinib, IRESSA™) in Postmenopausal Patients With Estrogen Receptor (ER) and/or Progesterone Receptor (PgR) Metastatic Breast Cancer” NCT00077025

Gefitinib(Iressa,YiRuiKe), Erlotinib(Tarceva), Icotinib(Kaimeina), Osimertinib(Tagrisso), Almonertinib, Furmonertinib, etc.” NCT04401059

Gefitinib blocks the function of epidermal growth factor receptor which is a key factor in stimulating liver cancer growth.” NCT00282100

“Standard EGFR-TKI(Gefitinib, erlotinib or icotinib) Gefitinib: 250mg po Qd Erlotinib: 150mg po Qd Icotinib: 125mg po tid” NCT03595644

“Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test.” NCT03119519

Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.” NCT00258323

“Imatinib tablets, 125 mg tid po; gefitinib tablets, 250 mg qd po; erlotinib tablets, 150 mg qd po” NCT03389256

“if EGFR mutation is positive, (gefitinib, ecotinib, erlotinib)or ALK/ROS-1 positive(Crizotinib)” NCT04193007

“With sensitive result the first-line therapy will be Erlotinib/Gefitinib/Crizotinib.” NCT02701231

“small molecules such as gefitinib (Iressa [ZD1839]; AstraZeneca, Wilmington, DE).” NCT00173875

Gefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid” NCT02788058

Gefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid” NCT02787447

Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid” NCT02714010

Gefitinib 250mg/QD plus vorinostat D1\~7 \& D15-21 / QD q 4weeks” NCT01027676

Gefitinib 250mg or Erlotinib 150mg medication, Once-Daily.” NCT03382795

Gefitinib maintenance therapy versus Gefitinib monotherapy” PMID 26725183 Dec 2015

“EGFR-TKIs include but are not limited erlotinib, gefitinibNCT03461185

“Drug: Trastuzumab Drug: Gefitinib Drug: Lapatinib” NCT03768375

gefitinib will be administered 250mg/d ivgtt qd” NCT03258671

Gefitinib is administered 250 mg once per day.” NCT04007835

“Pemetrexed (ALIMTA) and Gefitinib (IRESSA®)” NCT01066195

“Pemetrexed 500mg/m2 iv and Gefitinib 250 mg” NCT01579630

gefitinib 250mg/QD po daily every 3 weeks” NCT00452244

“Fludarabine Gefitinib Gemcitabine HCl” NCT02551718

“Fluorouracil, Gefitinib, Gemcitabine” NCT02788201

“EGFR-TKI (gefitinib 250mg per day)” NCT03002844

“afatinib, gefitinib, erlotinib” NCT02906163

“EGFR-TKI (gefitinib)” NCT02859077

“Iressa (Gefitinib)” NCT00233636

“Iressa (Gefitinib)” NCT00233623

“ZD1839 (Gefitinib)” NCT00034879

GefitinibNCT02142036

NCT01833572

NCT00637026

NCT00026364

NCT00040794

NCT00027690

NCT00027625

NCT00268255

NCT01864681

NCT01404260

NCT00497250

NCT03399669

NCT03381066

NCT00344773

NCT00005806

NCT00062062

NCT00100945

NCT01513174

NCT03381430

NCT07477457

NCT00082667

NCT00807066

NCT03758287

NCT02951637

NCT01466660

NCT00258297

NCT00955695

NCT03267654

NCT00212108

NCT02882984

NCT00234468

NCT00234442

NCT04358562

NCT00608868

NCT00234429

NCT00025675

NCT00237900

NCT00234416

NCT00238251

NCT01732276

NCT00132158

NCT02148380

NCT00076388

NCT00536107

NCT01310855

NCT01039948

NCT00234403

NCT00259064

NCT00025350

NCT00238797

NCT03239015

NCT04028778

NCT01783834

NCT00041106

NCT00169221

NCT01951469

NCT00632723

NCT01610336

NCT03766490

NCT03457337

NCT00075439

NCT00467077

NCT00239291

NCT01784549

NCT00239304

NCT00135135

NCT00239343

NCT01485809

NCT00025207

NCT00478049

NCT04642547

NCT01933347

NCT00025142

NCT01203917

NCT03856697

NCT01530334

NCT00025116

NCT00062270

NCT00091156

NCT00029003

NCT00256711

NCT03849768

NCT00162318

NCT03653546

NCT02321293

NCT00809237

NCT00083057

NCT00040781

NCT04425187

NCT07271446

NCT00188617

NCT00030524

NCT00130702

NCT00986284

NCT00198393

NCT00024154

NCT01556191

NCT00820417

NCT03599518

NCT00024089

NCT01776684

NCT03333343

NCT00255489

NCT00255476

NCT00255463

NCT00891579

NCT00198380

NCT00049062

NCT00241475

NCT02088112

NCT01196234

NCT00177242

NCT00333294

NCT00357734

NCT02484755

NCT00298688

NCT01982955

NCT00616499

NCT00080743

NCT01017679

NCT00023699

NCT01570296

NCT01291823

NCT03264794

NCT02374645

NCT02804776

NCT00242749

NCT00317772

NCT03656393

NCT00093652

NCT02299765

NCT02836847

NCT04239833

NCT00068497

NCT00042991

NCT00080340

NCT00086957

NCT03170180

NCT00409006

NCT03529084

NCT00012337

NCT00290719

NCT03944772

NCT07458919

NCT02025218

NCT00242788

NCT00352079

NCT02447419

NCT00242801

NCT01749072

NCT00588445

NCT02889692

NCT00049543

NCT00049556

NCT01774721

NCT02824458

NCT00098462

NCT03602027

NCT01544179

NCT00229723

NCT00265070

NCT00229697

NCT00014144

NCT03374280

NCT00014170

NCT00014183

NCT01469000

NCT01024413

NCT00411047

NCT03040973

NCT00084708

NCT02518802

NCT00039390

NCT02326285

NCT02282267

NCT01024712

NCT01955421

NCT00103051

NCT01363557

NCT00084786

NCT00635856

NCT00113529

NCT00020709

NCT00264498

NCT00635973

NCT00228488

NCT03123484

NCT01498562

NCT00455936

NCT01871480

NCT01405079

NCT00252811

NCT03292133

NCT00252798

NCT01755923

NCT01040780

NCT02411448

NCT01405846

NCT00614809

NCT00252707

NCT00483561

NCT00310154

NCT04390984

NCT02930954

NCT01192243

NCT00206219

NCT00193284

NCT00066339

NCT01158170

NCT02387086

NCT00087334

NCT00052754

NCT03122717

NCT02013089

NCT02856893

NCT00770588

NCT01965275

NCT00033449

NCT03157310

NCT00052585

NCT01769066

NCT01502202

NCT00509002

NCT00372515

NCT00127829

NCT03720873

NCT02338011

NCT00006049

NCT04143607

NCT00088907

NCT02151721

NCT04248829

NCT06071013

NCT02179671

NCT02039674

NCT00319618

NCT02929693

NCT02031601

NCT00217698

NCT00066378

NCT00071994

NCT02319577

NCT03787992

NCT02976116

NCT00126555

NCT00423397

NCT00246974

NCT02040064

NCT00519077

NCT00247481

NCT00144066

NCT00095836

NCT00681967

NCT03050411

NCT02893332

NCT01602289

NCT02296125

NCT02588261

NCT00319800

NCT00493025

NCT00085566

NCT00057941

NCT01510990

NCT03203590

NCT00096486

NCT00322452

NCT00052208

NCT00016991

NCT00006048

NCT03486496

NCT03866499

NCT00824746

Known as Comparator product ClinicalTrials.gov intervention name — accepted as the source's own label NCT02184325
Known as CTTQ “Gefitinib Tab 250 MG(CTTQ),From the 8th day of trial.” NCT03264794
Known as GEF “with the EGFR signaling inhibitor gefitinib (GEF) combined with weekly intravenous paclitaxel (PAC) and radiation therapy (RT).” PMID 19879702 Oct 2009
Known as Gefitinib (Iressa) Gefitinib (Iressa)NCT01749072
2

Gefitinib (Iressa)NCT01746277

gefitinib (Iressa)NCT02321293

Known as Gefitinib mylan ChEMBL registry synonym — accepted as the source's own label CHEMBL939
Known as GFT “patients with BM from NSCLC were randomly assigned to 30Gy WBRT with either concomitant gefitinib (GFT) 250mg/day continuously or temozolomide (TMZ) 75mg/m(2) for 21/28days.” PMID 22093943 Nov 2011
Known as IRESSA “PURPOSE: This phase II trial assessed the activity and tolerability of a daily oral dose of 500 mg gefitinib (ZD1839, Iressa) in patients with recurrent or persistent...” PMID 16061871 Aug 2005
60

“A Randomized, Open-Label, Parallel Group, International, Multicenter, Phase III Study of Oral ZD1839 (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally...” NCT00076388

“A Randomised, Open Label, Parallel Group, Multi-Centre, Phase II Study of Progression Free Survival Comparing ZD1839 (IRESSA™) (250 MG Tablet) Versus Vinorelbine (30 MG/M2...” NCT00256711

“A Phase I/II Trial of Induction Chemotherapy Plus Gefitinib (Iressa) Followed by Concurrent Chemotherapy, Radiation Therapy, and Gefitinib (Iressa) For Patients With Locally...” NCT00193284

“Randomised Placebo-controlled Phase II Trial of Preoperative Therapy With Gefitinib (Iressa®/ZD1839) and Epirubicin-Cyclophosphamide in Patients With Primary Operable (T2-T3)...” NCT00239343

“An EORTC Randomized, Double Blind, Placebo-Controlled, Phase II Multi-Center Trial Of Anastrozole (Arimidex) In Combination With ZD 1839 (Iressa) Or Placebo In Patients With...” NCT00066378

“Phase II Pilot Study of Clinical Activity and Proteomic Pathway Profiling of the EGFR Inhibitor, ZD1839 (Iressa; Gefitinib), in Patients With Epithelial Ovarian Cancer or...” NCT00049556

“This study aims to determine effectiveness of Gefitinib (Iressa) in recurrent glioblastoma after standard treatment (surgery, radiationtherapy and at least a first line chemotherapy).” NCT00250887

“A Phase I/II Pilot Study of Bioimmunotherapy With IRESSA (Gefitinib) and Pegylated Interferon Alpha-2a for Patients With Unresectable/Metastatic Squamous Cell Carcinoma of the Skin” NCT00423397

“Maintenance ZD1839 (IRESSA®) Following Completion of Front Line, Platinum-Based, Double Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer” NCT00090675

“A Randomized Phase III Study of Follow Up With or Without Adjuvant Gefitinib (Iressa™) Following Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer” NCT00091156

“the epidermal growth factor receptor tyrosine kinase inhibitor gefitinib (Iressa) in combination with paclitaxel (Taxol) and external beam radiation therapy” PMID 19060587 Dec 2008

“Phase II Trial of Neoadjuvant Docetaxel and ZD 1839 (Iressa) Followed by Radical Prostatectomy in Patients With High Risk, Locally Advanced Prostate Cancer” NCT00242918

“A Phase I Study of ZD1839 (Iressa) in Combination With Irinotecan (Camptosar or CPT-11) and Vincristine in Pediatric Patients With Refractory Solid Tumors” NCT00186979

“The purpose of the study is to determine the efficacy of gefitinib (IressaTM) in combination with radiotherapy on patients with glioblastoma multiforme.” NCT00238797

“A Phase II Trial to Evaluate the Combination of ZD1839 (Iressa) and Fulvestrant (Faslodex®) in Patients With Advanced or Metastatic Breast Cancer” NCT00234403

“Multicenter Phase II Trial of Gefitinib (Iressa™) First Line Therapy Followed by Chemotherapy in Advanced Non-Small Cell Lung Cancer (NSCLC)” NCT00217698

“Phase I/II study of gefitinib (Iressa(®)) and vorinostat (IVORI) in previously treated patients with advanced non-small cell lung cancer.” PMID 25552401 Jan 2015

“A Phase II Study of ZD1839 (Iressa)in Chemotherapy Refractory Germ Cell Tumors Expressing Epidermal Growth Factor Receptor (EGFR)” NCT00198159

“75 patients received tyrosine kinase inhibitor daily. (dose: Osimertinib 80 mg/d, or Tarceva 150 mg/d, or Iressa 0.25 g/d.)” NCT03799094

“A Phase I/II Study of Bexarotene in Combination With ZD1839 (IRESSA®) in the Treatment of Non-Small Cell Lung Cancer” NCT00238628

“Safety Study to Explore Combination of Gefitinib (ZD1839, Iressa) and Radiotherapy in Non-Metastatic Prostate Cancer” NCT00239291

“Gefitinib (EGFR Tyrosine Kinase Inhibitor, Iressa™) in Combination With BKM120, an Oral Pan-class I PI3K Inhibitor” NCT01570296

“Gefitinib (Iressa) in Combo With Chemoradiation in Patients With Locally Advanced Head & Neck Cancer” NCT00239304

“Adjuvant Therapy of Gefitinib (Iressa, ZD1839) in Patients With Resectable Hepatocellular Carcinoma” NCT00282100

“Topotecan and Gefitinib (Iressa) for Ovarian, Peritoneal, or Fallopian Tube Cancer” NCT00317772

“Cediranib (AZD2171) Plus Gefitinib (Iressa, ZD1839) With Cediranib Plus Placebo” NCT01310855

“ZD1839 (IRESSA®) in Previously Untreated Elderly Patients (≥70 Years Old)” NCT00231465

“Phase II of Gefitinib (IRESSA) Administered as First-line Treatment” NCT00198380

“A Study of IRESSA in Relapsed and Refractory Small Cell Lung Cancer” NCT00298688

“Study treatment will consist of Iressa (gefitinib) alone.” NCT00228488

“Intercalated administration of Iressa® (gefitinib)” NCT01502202

“Tyrosine Kinase Inhibitor gefitinib (Iressa)” NCT02321293

“Pemetrexed (ALIMTA) and Gefitinib (IRESSA®)” NCT01066195

“Drug: ZD1839 (IRESSA)” NCT01185158

Iressa (Gefitinib)” NCT00234468

“Gefitinib (IRESSA)” NCT00891579

“Gefitinib (IRESSA)” NCT01363557

“gefitinib (Iressa)” NCT00080340

Iressa (Gefitinib)” NCT00169221

Iressa (Gefitinib)” NCT00234442

“ZD1839 (IRESSA™)” NCT00242762

“ZD1839 (IRESSA®)” NCT00185835

“ZD1839 (Iressa™)” NCT00059722

“ZD1839 (IRESSA)” NCT00006048

“ZD1839 (IRESSA)” NCT00195078

“ZD1839 (Iressa)” NCT00328562

NCT00233636

NCT01312337

NCT01066195

NCT00238628

NCT00054691

NCT00233623

NCT00181688

NCT01037998

NCT00215202

NCT00352105

NCT00206414

NCT00206492

NCT00173875

NCT00319787

Known as Iressa TM “The purpose of the study is to determine the efficacy of gefitinib (IressaTM) in combination with radiotherapy on patients with glioblastoma multiforme.” NCT00238797
2

“A Phase I Study Of ZD1839 (Iressa TM), An Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor, In Children With Refractory Solid Tumors” NCT00040781

“Gefitinib (Iressa TM) Arm - Gefitinib administration 250mg tablet once daily every 3 weeks” NCT00455936

Known as NSC-759856 ChEMBL registry synonym — accepted as the source's own label CHEMBL939
Known as Yi Ruisha “Gefitinib tablets (Yi Ruisha),First medication,250mg;” NCT03264794
Known as ZD 1839 “PURPOSE: This phase II trial assessed the activity and tolerability of a daily oral dose of 500 mg gefitinib (ZD1839, Iressa) in patients with recurrent or persistent...” PMID 16061871 Aug 2005
53

“A Randomized, Open-Label, Parallel Group, International, Multicenter, Phase III Study of Oral ZD1839 (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally...” NCT00076388

“A Randomised, Open Label, Parallel Group, Multi-Centre, Phase II Study of Progression Free Survival Comparing ZD1839 (IRESSA™) (250 MG Tablet) Versus Vinorelbine (30 MG/M2...” NCT00256711

“The purpose of this study is to determine if the addition of ZD1839 Iressa™ to standard treatment with Casodex® (bicalutamide) for locally advanced prostate cancer can detect a...” NCT00319787

“Randomised Placebo-controlled Phase II Trial of Preoperative Therapy With Gefitinib (Iressa®/ZD1839) and Epirubicin-Cyclophosphamide in Patients With Primary Operable (T2-T3)...” NCT00239343

“A Phase II Open-Label Multicentre Study Of The Efficacy Of ZD1839 (IRESSA™) In Combination With Irradiation Followed By Chemotherapy In Patients With Inoperable Stage III Non...” NCT00333294

“An EORTC Randomized, Double Blind, Placebo-Controlled, Phase II Multi-Center Trial Of Anastrozole (Arimidex) In Combination With ZD 1839 (Iressa) Or Placebo In Patients With...” NCT00066378

“Over the last three years, the FDA has approved two drugs for salvage treatment of NSCLC, gefitinib (Iressa ®, formerly known as ZD1839) and erlotinib (Tarceva ®, formerly...” NCT00809237

“Phase II Pilot Study of Clinical Activity and Proteomic Pathway Profiling of the EGFR Inhibitor, ZD1839 (Iressa; Gefitinib), in Patients With Epithelial Ovarian Cancer or...” NCT00049556

“This is a phase II window study of the combination of ZD1839 (gefitinib) and irinotecan in children with high-risk neuroblastoma followed by standard induction chemotherapy” NCT00135135

“Combination Anastrozole-ZD1839 (Gefitinib, IRESSA™) in Postmenopausal Patients With Estrogen Receptor (ER) and/or Progesterone Receptor (PgR) Metastatic Breast Cancer” NCT00077025

“A Phase I Study of ZD1839 (Iressa) in Combination With Irinotecan (Camptosar or CPT-11) and Vincristine in Pediatric Patients With Refractory Solid Tumors” NCT00186979

“A Phase I Study Of ZD1839 (Iressa TM), An Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor, In Children With Refractory Solid Tumors” NCT00040781

“A Phase II Trial to Evaluate the Combination of ZD1839 (Iressa) and Fulvestrant (Faslodex®) in Patients With Advanced or Metastatic Breast Cancer” NCT00234403

“A Phase I/II Study of Bexarotene in Combination With ZD1839 (IRESSA®) in the Treatment of Non-Small Cell Lung Cancer” NCT00238628

“Safety Study to Explore Combination of Gefitinib (ZD1839, Iressa) and Radiotherapy in Non-Metastatic Prostate Cancer” NCT00239291

“Gefitinib (ZD1839) may stop the growth of cancer cells by blocking the enzymes necessary for their growth.” NCT00057941

“Adjuvant Therapy of Gefitinib (Iressa, ZD1839) in Patients With Resectable Hepatocellular Carcinoma” NCT00282100

“small molecules such as gefitinib (Iressa [ZD1839]; AstraZeneca, Wilmington, DE).” NCT00173875

“Cediranib (AZD2171) Plus Gefitinib (Iressa, ZD1839) With Cediranib Plus Placebo” NCT01310855

“Gefitinib (ZD1839), a Selective EGFR Tyrosine Kinase Inhibitor” NCT00820417

“ZD1839 (gefitinib)” NCT00357734

“ZD1839 (IRESSA®)” NCT00185835

“Iressa (ZD1839)” NCT00181688

“Iressa (ZD1839)” NCT00215202

NCT00268346

NCT00684385

NCT00026299

NCT00048087

NCT00189358

NCT00104728

NCT00683306

NCT00428896

NCT00479089

NCT01185171

NCT01185158

NCT00198159

NCT00090675

NCT00068653

NCT00242762

NCT00787410

NCT00185835

NCT00242918

NCT00231465

NCT00137761

NCT00215995

NCT00059722

NCT00502060

NCT00015964

NCT00328562

NCT00034879

NCT00193336

NCT00195078

NCT00052169

Known as ZD1839, gefitinib (Iressa) ZD1839, gefitinib (Iressa)NCT00052169
Action Inhibit “ZD 1839 may interfere with the growth factor and stop the tumor from growing.” NCT00006048
Modality Small molecule “An Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI)” NCT00052208
Route Oral “higher dose oral ZD 1839” NCT00006048
Target EGFR “In tumor samples, gefitinib did not inhibit activation of its proximal target, EGFR.” PMID 16361624 Dec 2005