{"preliminary_commentary":{"by_channel":{"x_thread":2,"bluesky_thread":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"ORCHARD","nct_id":"NCT03944772","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=orchard-nct03944772. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"ORCHARD","arms":[{"description":"The patients in this group will receive osimertinib taken in combination with savolitinib","label":"Module 1: Osimertinib + Savolitinib","type":"EXPERIMENTAL"},{"description":"The patients in this group will receive osimertinib taken in combination with gefitinib","label":"Module 2: Osimertinib + Gefitinib","type":"EXPERIMENTAL"},{"description":"The patients in this group will receive osimertinib taken in combination with necitumumab","label":"Module 3: Osimertinib + Necitumumab","type":"EXPERIMENTAL"},{"description":"The patients in this group will receive platinum-containing doublet (carboplatin + pemetrexed) taken in combination with durvalumab.","label":"Module 4: Carboplatin + Pemetrexed + Durvalumab)","type":"EXPERIMENTAL"},{"description":"Patients in this group will not receive study treatment but receive further anticancer care (Standard of Care therapy or other experimental therapies) or supportive care, as clinically indicated, in accordance with local practice.\n\nWith Group C, the aim is to understand the clinical course and/or outcome for the overall clinical population after progression on first-line monotherapy with osimertinib.","label":"Observational Cohort: No study drug","type":"NO_INTERVENTION"},{"description":"The patients in this group will receive osimertinib taken in combination with alectinib","label":"Module 5: Osimertinib + Alectinib","type":"EXPERIMENTAL"},{"description":"The patients in this group will receive osimertinib taken in combination with selpercatinib","label":"Module 6: Osimertinib + Selpercatinib","type":"EXPERIMENTAL"},{"description":"The patients in this group will receive platinum-containing doublet (etoposide + carboplatin or cisplatin) taken in combination with durvalumab.","label":"Module 7: Etoposide + Durvalumab + Carboplatin or Cisplatin","type":"EXPERIMENTAL"},{"description":"The patients in this group will receive Osimertinib plus platinum-containing doublet (pemetrexed + carboplatin or cisplatin).","label":"Module 8: Osimertinib + Pemetrexed + Carboplatin or Cisplatin.","type":"EXPERIMENTAL"},{"description":"The patients in this group will receive osimertinib taken in combination with selumetinib","label":"Module 9: Osimertinib + Selumetinib","type":"EXPERIMENTAL"},{"description":"The patients in this group will receive osimertinib taken in combination with datopotamab deruxtecan.","label":"Module 10: Osimertinib + datopotamab deruxtecan","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2025-05-06","type":"ESTIMATED"},"conditions":["Non-Small Cell Lung Cancer"],"enrollment":{"count":247,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Osimertinib","otherNames":["TAGRISSO"],"type":"DRUG"},{"name":"Savolitinib","otherNames":[],"type":"DRUG"},{"name":"Gefitinib","otherNames":["Iressa"],"type":"DRUG"},{"name":"Necitumumab","otherNames":["Portrazza"],"type":"DRUG"},{"name":"Durvalumab","otherNames":["IMFINZI"],"type":"DRUG"},{"name":"Carboplatin","otherNames":[],"type":"DRUG"},{"name":"Pemetrexed","otherNames":[],"type":"DRUG"},{"name":"Alectinib","otherNames":["Alecensa"],"type":"DRUG"},{"name":"Selpercatinib","otherNames":["Loxo-292, Retevmo, Retsevmo"],"type":"DRUG"},{"name":"Selumetinib","otherNames":["Koselugo"],"type":"DRUG"},{"name":"Etoposide","otherNames":[],"type":"DRUG"},{"name":"Cisplatin","otherNames":[],"type":"DRUG"},{"name":"Datopotamab deruxtecan","otherNames":["DS 1062a"],"type":"DRUG"}],"last_update":"2025-01-30","lead_sponsor":"AstraZeneca","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.","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2025-05-06","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Objective response rate (ORR)","timeFrame":"Measured from first dose until confirmed response or progression. For each patient this is expected to be 3 months on average"}],"references":[{"citation":"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.","pmid":"42361644","type":"DERIVED"},{"citation":"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.","pmid":"41780641","type":"DERIVED"},{"citation":"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.","pmid":"41130408","type":"DERIVED"},{"citation":"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.","pmid":"40466026","type":"DERIVED"},{"citation":"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.","pmid":"39521433","type":"DERIVED"},{"citation":"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.","pmid":"34389237","type":"DERIVED"},{"citation":"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.","pmid":"32027845","type":"DERIVED"}],"start_date":{"date":"2019-06-25","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)","url":"https://clinicaltrials.gov/study/NCT03944772"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/orchard-nct03944772"}