{"preliminary_commentary":{"by_channel":{"x_thread":12,"podcast":2},"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\": \"NCT03829319\", \"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":[["lenvatinib","pembrolizumab"]],"indication":"first-line metastatic nonsquamous non-small cell lung cancer","name":"LEAP-006","nct_id":"NCT03829319","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=leap-006-nct03829319. 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":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants receive carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib via oral capsule once daily.","label":"Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Lenvatinib","type":"EXPERIMENTAL"},{"description":"In Parts 1 and 2: Participants receive carboplatin AUC5 or cisplatin 75 mg/m\\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS (Part 2 only) placebo matching lenvatinib via oral capsule once daily.","label":"Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Placebo","type":"PLACEBO_COMPARATOR"}],"collaborators":["Eisai Inc."],"completion_date":{"date":"2024-08-30","type":"ACTUAL"},"conditions":["Nonsquamous Non-small Cell Lung Cancer"],"enrollment":{"count":761,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Pembrolizumab","otherNames":["MK-3475"],"type":"BIOLOGICAL"},{"name":"Carboplatin","otherNames":[],"type":"DRUG"},{"name":"Cisplatin","otherNames":[],"type":"DRUG"},{"name":"Pemetrexed","otherNames":[],"type":"DRUG"},{"name":"Lenvatinib","otherNames":["MK-7902","E7080"],"type":"DRUG"},{"name":"Placebo matching lenvatinib","otherNames":[],"type":"DRUG"}],"last_update":"2026-02-05","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Phase 3 Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First-line Intervention in Participants With Metastatic Nonsquamous Non-small Cell Lung Cancer (LEAP-006)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2023-08-11","type":"ACTUAL"},"primary_outcomes":[{"measure":"Part 1: Number of Participants With a Dose-limiting Toxicity (DLT)","timeFrame":"Cycle 1; each cycle is 21 days (up to 21 days)"},{"measure":"Part 1: Number of Participants Who Experienced an Adverse Event (AE)","timeFrame":"Up to approximately 48 months"},{"measure":"Part 1: Number of Participants Who Discontinued Study Drug Due to an Adverse Event","timeFrame":"Up to approximately 58 months"},{"measure":"Part 2: Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)","timeFrame":"Up to approximately 36 months"},{"measure":"Part 2: Overall Survival (OS)","timeFrame":"Up to approximately 47 months"}],"references":[{"citation":"Herbst RS, Cho BC, Zhou C, Burotto M, Dols MC, Sendur MAN, Moiseyenko V, Casarini I, Nishio M, Hui R, Pons-Tostivint E, Dudnik J, Ahmed S, Okpara CE, Dutcus C, Yin L, Luo Y, Chirovsky D, Bhagwati N, Abreu DR. Lenvatinib Plus Pembrolizumab, Pemetrexed, and a Platinum as First-Line Therapy for Metastatic Nonsquamous NSCLC: Phase 3 LEAP-006 Study. J Thorac Oncol. 2025 Sep;20(9):1302-1314. doi: 10.1016/j.jtho.2025.05.016. Epub 2025 May 24.","pmid":"40419140","type":"RESULT"}],"start_date":{"date":"2019-03-25","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006)","url":"https://clinicaltrials.gov/study/NCT03829319"},"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/leap-006-nct03829319"}