Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)

Summary

Phase 2 Platform Study in Patients with Advanced Non-Small Lung Cancer who progressed on First-Line Osimertinib Therapy. This study is modular in design, allowing evaluation of the efficacy, safety and tolerability of multiple study treatments.

Timeline

Start

2019-06-25

Primary completion

2025-05-06

Completion

2025-05-06

Publications

• Okamoto I, Cho BC, Goldberg SB, Goldman JW, de Langen AJ, Piotrowska Z, Riess JW, Yu HA, Garcia Campelo MR, Cetnar J, Kim YJ, Novello S, Shiraishi Y, Ambrose H, Smith PE, Tang KH, Lehman JM, Le X. Durvalumab plus etoposide-platinum in patients with epidermal growth factor receptor (EGFR)-mutated advanced NSCLC and neuroendocrine transformation after first-line osimertinib: ORCHARD. Lung Cancer. 2026 Jun 18;218:109501. doi: 10.1016/j.lungcan.2026.109501. Online ahead of print.
• Riess JW, Yu HA, Le X, de Langen AJ, Cho BC, Piotrowska Z, Hendriks LEL, Morabito A, Bonanno L, Brustugun OT, Halvorsen TO, Kim YJ, Marrone KA, Shiraishi Y, Goldman JW, Ambrose H, Smith PE, FraenkeI PG, Tang KH, Lehman JM, Goldberg SB. Osimertinib plus datopotamab deruxtecan in patients with EGFR-mutated advanced NSCLC after progression on first-line osimertinib: ORCHARD. Ann Oncol. 2026 Jun;37(6):825-836. doi: 10.1016/j.annonc.2026.02.014. Epub 2026 Mar 2.
• Le X, Baik C, Cho BC, Riess JW, Piotrowska Z, Johannes de Langen A, Goldberg SB, Goldman JW, Reguart N, Shiraishi Y, Ambrose H, Fraenkel PG, Ruiz BM, Smith PE, Tang KH, Yu HA. Osimertinib Plus Savolitinib in Patients With EGFR-Mutated Advanced NSCLC With MET Alterations After First-Line Osimertinib: Clinical Outcomes, Safety, and Biomarker Analysis: A Brief Report. J Thorac Oncol. 2026 Feb;21(2):318-327. doi: 10.1016/j.jtho.2025.10.009. Epub 2025 Oct 21.
• Riess JW, de Langen AJ, Ponce S, Goldberg SB, Piotrowska Z, Goldman JW, Le X, Cho BC, Yoneshima Y, Ambrose H, Cavazzina R, Tang KH, Lau J, Yu HA. ORCHARD: Osimertinib Plus Necitumumab in Patients With Epidermal Growth Factor Receptor-Mutated Advanced Non-Small Cell Lung Cancer With a Secondary Epidermal Growth Factor Receptor Alteration Whose Disease Had Progressed on First-Line Osimertinib. JCO Precis Oncol. 2025 Jun;9:e2400818. doi: 10.1200/PO-24-00818. Epub 2025 Jun 4.
• Lu S, Wu L, Wang Q, Wang Z, Lv D, Ma R, Zhu B, van Tran N, Jiang L, Nan K, Laktionov K, Clarke S, Song M, Mann H, Liu Y, Shi X, Wu YL. Durvalumab Versus Chemotherapy as First-line Treatment for Metastatic NSCLC With Tumor PD-L1 Expression of 25% or Higher: Results From the Randomized Phase 3 PEARL Study. J Thorac Oncol. 2025 Mar;20(3):366-382. doi: 10.1016/j.jtho.2024.10.024. Epub 2024 Nov 7.
• Yu HA, Goldberg SB, Le X, Piotrowska Z, Goldman JW, De Langen AJ, Okamoto I, Cho BC, Smith P, Mensi I, Ambrose H, Kraljevic S, Maidment J, Chmielecki J, Li-Sucholeiki X, Doughton G, Patel G, Jewsbury P, Szekeres P, Riess JW. Biomarker-Directed Phase II Platform Study in Patients With EGFR Sensitizing Mutation-Positive Advanced/Metastatic Non-Small Cell Lung Cancer Whose Disease Has Progressed on First-Line Osimertinib Therapy (ORCHARD). Clin Lung Cancer. 2021 Nov;22(6):601-606. doi: 10.1016/j.cllc.2021.06.006. Epub 2021 Jun 25.
• Schmid S, Fruh M, Peters S. Targeting MET in EGFR resistance in non-small-cell lung cancer-ready for daily practice? Lancet Oncol. 2020 Mar;21(3):320-322. doi: 10.1016/S1470-2045(19)30859-9. Epub 2020 Feb 3. No abstract available.

Drugs

Indications