{"preliminary_commentary":{"by_channel":{"x_thread":44,"podcast":13,"youtube":12},"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT05973773\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"name":"REZILIENT 3","nct_id":"NCT05973773","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=rezilient-3-nct05973773. 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":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"REZILIENT3","arms":[{"description":"Part A: Safety Lead-In Approximately 6-12 patients will receive zipalertinib administered at an initial dose of zipalertinib PO BID (Dose Level 1) in combination with pemetrexed and carboplatin or cisplatin on a 21-day cycle. Patients may continue to receive study treatment until documentation of progressive disease (PD) or until other withdrawal criteria are met, whichever comes first.","label":"Part A (Safety Lead in)","type":"EXPERIMENTAL"},{"description":"Enrollment into the Phase 3 portion of the study will begin following completion of Part A.\n\nApproximately 260 patients will be randomized on a 1:1 basis to receive pemetrexed and a platinum agent (either carboplatin or cisplatin) with or without zipalertinib on a 21-day cycle.\n\nCarboplatin or cisplatin will be administered for 4 cycles. Patients may continue to receive zipalertinib (experimental study arm) and pemetrexed (both study arms) until documentation of PD or until other withdrawal criteria are met, whichever comes first.","label":"Part B","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-05-27","type":"ESTIMATED"},"conditions":["Advanced or Metastatic NSCLS With Exon 20 Insertion Mutation"],"enrollment":{"count":285,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"TAS6417","otherNames":["Zipalertinib","CLN-081"],"type":"DRUG"}],"last_update":"2026-07-30","lead_sponsor":"Taiho Oncology, Inc.","official_title":"Randomized, Controlled, Open-label, Phase 3, Global Multi - Center Trial to Assess the Efficacy and Safety of Zipalertinib Plus Chemotherapy Versus Chemotherapy Alone, in Patients With Previously Untreated, Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2027-05-27","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Part A and B: The rate and severity of treatment emergent AEs","timeFrame":"approximately 5 years"},{"measure":"Part A and Part B: Progression-free survival (PFS) by blinded independent central review (BICR)","timeFrame":"approximately 5 years"},{"measure":"Part A: The rate and severity of DLTs according to the NCI-Common Terminology Criteria of Adverse Events (CTCAE) v5.0 during Cycle 1","timeFrame":"approximately 5 years"}],"references":[{"citation":"Heymach JV, Yu HA, Besse B, Cheng Y, Tan DS, Wei L, Wacheck V, Nishio M. REZILIENT3: randomized phase III study of first-line zipalertinib plus chemotherapy in patients with EGFR exon 20 insertion-mutated NSCLC. Future Oncol. 2025 Feb;21(5):549-556. doi: 10.1080/14796694.2025.2457294. Epub 2025 Feb 16.","pmid":"39957151","type":"DERIVED"}],"start_date":{"date":"2023-12-18","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)","url":"https://clinicaltrials.gov/study/NCT05973773"},"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/rezilient-3-nct05973773"}