{"preliminary_commentary":{"by_channel":{"x_thread":30,"podcast":22,"youtube":11},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03940703\", \"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."},"commentary_summary":null,"drugs_tested":null,"indication":"advanced EGFR-mutated MET-amplified NSCLC following first-line osimertinib progression","name":"INSIGHT 2","nct_id":"NCT03940703","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=insight-2-nct03940703. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants received a single oral dose of Tepotinib 500 milligrams (mg) followed by Omisertinib 80 mg once daily until disease progression, death, adverse event leading to discontinuation, study withdrawal or consent withdrawal.","label":"Tepotinib and Osimertinib","type":"EXPERIMENTAL"},{"description":"Participants received a single oral dose of Tepotinib 500 mg until disease progression, death, adverse event leading to discontinuation, study withdrawal or consent withdrawal.","label":"Tepotinib Mono-therapy","type":"EXPERIMENTAL"}],"collaborators":["Merck KGaA, Darmstadt, Germany"],"completion_date":{"date":"2026-07-15","type":"ACTUAL"},"conditions":["Non-small Cell Lung Cancer"],"enrollment":{"count":140,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Tepotinib","otherNames":[],"type":"DRUG"},{"name":"Osimertinib","otherNames":["Tagrisso®"],"type":"DRUG"}],"last_update":"2026-08-21","lead_sponsor":"EMD Serono Research & Development Institute, Inc.","official_title":"A Phase II, Two-arm Study to Investigate Tepotinib Combined With Osimertinib in MET Amplified, Advanced or Metastatic NSCLC Harboring Activating EGFR Mutations and Having Acquired Resistance to Prior Osimertinib Therapy (INSIGHT 2)","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2023-05-11","type":"ACTUAL"},"primary_outcomes":[{"measure":"Combined Therapy (Tepotinib+Osimertinib): Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version (NCI-CTCAE v 5.0)","timeFrame":"Up to Day 21 of Cycle 1 (each Cycle is of 21 days)"},{"measure":"Combined Therapy: Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)Version1.1as Per Independent Review Committee in Participants With MET Amplification Determined Centrally by Fluorescence in Situ Hybridization(FISH)","timeFrame":"Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)"}],"references":[{"citation":"F Smit E, Dooms C, Raskin J, Nadal E, Tho LM, Le X, Mazieres J, S Hin H, Morise M, W Zhu V, Tan D, H Holmberg K, Ellers-Lenz B, Adrian S, Brutlach S, Schumacher KM, Karachaliou N, Wu YL. INSIGHT 2: a phase II study of tepotinib plus osimertinib in MET-amplified NSCLC and first-line osimertinib resistance. Future Oncol. 2022 Mar;18(9):1039-1054. doi: 10.2217/fon-2021-1406. Epub 2021 Dec 17.","pmid":"34918545","type":"BACKGROUND"},{"citation":"Wu YL, Guarneri V, Voon PJ, Lim BK, Yang JJ, Wislez M, Huang C, Liam CK, Mazieres J, Tho LM, Hayashi H, Nhung NV, Chia PL, de Marinis F, Raskin J, Zhou Q, Finocchiaro G, Le AT, Wang J, Dooms C, Kato T, Nadal E, Hin HS, Smit EF, Wermke M, Tan D, Morise M, O'Brate A, Adrian S, Pfeiffer BM, Stroh C, Juraeva D, Strotmann R, Goteti K, Berghoff K, Ellers-Lenz B, Karachaliou N, Le X, Kim TM; INSIGHT 2 investigators. Tepotinib plus osimertinib in patients with EGFR-mutated non-small-cell lung cancer with MET amplification following progression on first-line osimertinib (INSIGHT 2): a multicentre, open-label, phase 2 trial. Lancet Oncol. 2024 Aug;25(8):989-1002. doi: 10.1016/S1470-2045(24)00270-5.","pmid":"39089305","type":"BACKGROUND"},{"citation":"Hallick J, Baird AM, Falchook G, Le X, Hong D, Viteri S, Raskin J, Reinmuth N, Vlassak S, Militaru M, Paik PK. Plain language summary of the development of tepotinib: a treatment for a subtype of non-small cell lung cancer called MET exon 14 skipping. Future Oncol. 2023 Mar;19(10):683-696. doi: 10.2217/fon-2022-1035. Epub 2023 Mar 31.","pmid":"36999526","type":"BACKGROUND"}],"start_date":{"date":"2019-09-19","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)","url":"https://clinicaltrials.gov/study/NCT03940703"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/insight-2-nct03940703"}