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Clinical trial · no report yet · Phase 2

ORCHARD

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

We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Preliminary discovery

Commentary in our index that names this trial so far

Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.

ChannelFound
X threads2
Bluesky threads1

The trial

ClinicalTrials.gov
Official title
A Biomarker-directed Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Whose Disease Has Progressed on First-Line Osimertinib Therapy.
Phase
Phase 2
Status
Active, not recruiting
Conditions
Non-Small Cell Lung Cancer
Interventions
Osimertinib; Savolitinib; Gefitinib; Necitumumab; Durvalumab; Carboplatin; Pemetrexed; Alectinib; Selpercatinib; Selumetinib; Etoposide; Cisplatin; Datopotamab deruxtecan
Arms
  • Module 1: Osimertinib + Savolitinib · Experimental
  • Module 2: Osimertinib + Gefitinib · Experimental
  • Module 3: Osimertinib + Necitumumab · Experimental
  • Module 4: Carboplatin + Pemetrexed + Durvalumab) · Experimental
  • Observational Cohort: No study drug · No intervention
  • Module 5: Osimertinib + Alectinib · Experimental
  • Module 6: Osimertinib + Selpercatinib · Experimental
  • Module 7: Etoposide + Durvalumab + Carboplatin or Cisplatin · Experimental
  • Module 8: Osimertinib + Pemetrexed + Carboplatin or Cisplatin. · Experimental
  • Module 9: Osimertinib + Selumetinib · Experimental
  • Module 10: Osimertinib + datopotamab deruxtecan · Experimental
Enrollment
247
Primary outcomes
  • Objective response rate (ORR)
Sponsor
AstraZeneca
Start
Jun 25, 2019
Primary completion
May 6, 2025 (estimated)
Results posted
No
Registry record
NCT03944772 · updated Jan 30, 2025

Publications

linked from the registry
  • 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 Aug;218:109501. doi: 10.1016/j.lungcan.2026.109501. Epub 2026 Jun 18. PubMed 42361644
  • 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. PubMed 41780641
  • 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. PubMed 41130408
  • 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. PubMed 40466026
  • 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. PubMed 39521433
  • 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. PubMed 34389237
  • 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. PubMed 32027845