{"preliminary_commentary":{"by_channel":{"x_thread":21,"youtube":4,"bluesky_thread":3,"podcast":2},"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\": \"NCT04036682\", \"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 1","nct_id":"NCT04036682","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=rezilient-1-nct04036682. 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":"REZILIENT1","arms":[{"description":"CLN-081 BID in single patient dose escalation cohorts enrolling NSCLC patients with EGFR exon 20 insertion mutations that either have received or never received prior EGFR TKIs.","label":"Phase 1 Dose Escalation (Accelerated Titration)","type":"EXPERIMENTAL"},{"description":"CLN-081 BID in Rolling Six dose escalation cohorts enrolling NSCLC patients with EGFR exon 20 insertion mutations.","label":"Phase 1 Dose Escalation (Rolling Six)","type":"EXPERIMENTAL"},{"description":"CLN-081 BID in expansion cohorts that may be opened at doses that meet pre-specified efficacy and safety criteria.","label":"Phase 2a Dose Expansion(s)","type":"EXPERIMENTAL"},{"description":"Single-dose CLN-081 150 mg with and without high fat food intake.","label":"Module A Food Affect","type":"EXPERIMENTAL"},{"description":"CLN-081 BID in NSCLC patients with EGFR exon 20 insertion mutations that have received prior systemic therapy for locally advanced or metastatic disease.","label":"Module B","type":"EXPERIMENTAL"},{"description":"CLN-081 BID to patients with EGFR exon 20 insertion mutant NSCLC after prior therapy with an agent approved for the treatment of ex20ins mutant NSCLC.","label":"Module C","type":"EXPERIMENTAL"}],"collaborators":["Taiho Oncology, Inc."],"completion_date":{"date":"2028-03-31","type":"ESTIMATED"},"conditions":["Non Small Cell Lung Cancer","EGFR Exon 20 Mutation"],"enrollment":{"count":284,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"CLN-081","otherNames":["TAS6417; zipalertinib"],"type":"DRUG"}],"last_update":"2026-06-17","lead_sponsor":"Cullinan Therapeutics Inc.","official_title":"A Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients With Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Previously Received Platinum-Based Systemic Chemotherapy","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2025-10-13","type":"ACTUAL"},"primary_outcomes":[{"measure":"All Cohorts: The rate and severity of treatment emergent AEs.","timeFrame":"24 months"},{"measure":"All Cohorts: The rate and severity of DLTs.","timeFrame":"24 months"},{"measure":"Phase 2 Dose Expansion Cohorts: Overall response rate (ORR)","timeFrame":"24 months"},{"measure":"Module A: Pharmacokinetic (PK) parameter","timeFrame":"24 months"},{"measure":"Module A: Pharmacokinetic (PK) parameter","timeFrame":"24 months"},{"measure":"Module B and C: Confirmed overall response rate (ORR) and duration of response (DOR) by independent review committee (IRC)","timeFrame":"24 months"}],"references":[{"citation":"Piotrowska Z, Passaro A, Nguyen D, Ruiter G, Soo RA, Ho-Fun Lee V, Velcheti V, Tan DS, Lee SH, Kim SH, Wrangle J, Yang JC, Daga H, Juan Vidal OJ, Spira AI, Fernandez-Hinojal G, Kim SW, Umemura S, Provencio Pulla M, Keeton EK, Yang ZS, Li S, Xu ZC, Jones JA, Yu HA; REZILIENT1 Investigators. Zipalertinib in Patients With Epidermal Growth Factor Receptor Exon 20 Insertion-Positive Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy With or Without Amivantamab. J Clin Oncol. 2025 Jul 20;43(21):2387-2397. doi: 10.1200/JCO-25-00763. Epub 2025 Jun 1.","pmid":"40450572","type":"DERIVED"},{"citation":"Piotrowska Z, Tan DS, Smit EF, Spira AI, Soo RA, Nguyen D, Lee VH, Yang JC, Velcheti V, Wrangle JM, Socinski MA, Koczywas M, Janik JE, Jones J, Yu HA. Safety, Tolerability, and Antitumor Activity of Zipalertinib Among Patients With Non-Small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertions. J Clin Oncol. 2023 Sep 10;41(26):4218-4225. doi: 10.1200/JCO.23.00152. Epub 2023 Jun 29.","pmid":"37384848","type":"DERIVED"},{"citation":"Ye L, Chen X, Zhou F. EGFR-mutant NSCLC: emerging novel drugs. Curr Opin Oncol. 2021 Jan;33(1):87-94. doi: 10.1097/CCO.0000000000000701.","pmid":"33122578","type":"DERIVED"}],"start_date":{"date":"2019-10-31","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer","url":"https://clinicaltrials.gov/study/NCT04036682"},"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-1-nct04036682"}