{"commentary":{"count":5,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":5},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":false},"name":"MARIPOSA","nct_id":"NCT04487080","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=mariposa-nct04487080. The price is fixed at order. We build the report after 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: 1–12 commentary sources"},"registry":{"acronym":"MARIPOSA","arms":[{"description":"Participants will receive amivantamab 1050 milligram (mg) intravenously (IV) for body weight less than (\\<) 80 kilogram (kg) and 1400 mg for body weight greater than or equal to (\\>=) 80 kg in 28-day cycles: once weekly in Cycle 1 (with a split dose on Days 1-2), and then every 2 weeks in subsequent cycles. Lazertinib will be administered 240 mg (80\\*3) orally once daily.","label":"Treatment Arm A (Open-label): Amivantamab and Lazertinib","type":"EXPERIMENTAL"},{"description":"Participants will receive osimertinib 80 mg orally once daily plus matching placebo of lazertinib 240 mg (80\\*3) orally once daily.","label":"Treatment Arm B (Double-blind): Osimertinib+Placebo Lazertinib","type":"ACTIVE_COMPARATOR"},{"description":"Participants will receive lazertinib 240 mg (80\\*3) orally once daily plus matching placebo of osimertinib 80 mg orally once daily.","label":"Treatment Arm C (Double-blind): Lazertinib+Placebo Osimertinib","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2028-02-16","type":"ESTIMATED"},"conditions":["Carcinoma, Non-Small-Cell Lung"],"enrollment":{"count":1074,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Amivantamab","type":"DRUG"},{"name":"Osimertinib","type":"DRUG"},{"name":"Lazertinib","type":"DRUG"},{"name":"Placebo","type":"DRUG"}],"last_update":"2026-09-28","lead_sponsor":"Janssen Research & Development, LLC","official_title":"A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2023-08-11","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)","timeFrame":"From randomization to either disease progression or death whichever occurs first (up to 32.8 months)"}],"references":[{"citation":"Yang JC, Lu S, Hayashi H, Felip E, Spira AI, Girard N, Kim YJ, Lee SH, Ostapenko Y, Danchaivijitr P, Liu B, Alip A, Korbenfeld E, Mourao Dias J, Besse B, Passaro A, Lee KH, Xiong H, How SH, Cheng Y, Chang GC, Yoshioka H, Thomas M, Nguyen D, Ou SI, Mukhedkar S, Prabhash K, D'Arcangelo M, Alatorre-Alexander J, Vazquez Limon JC, Alves S, Stroyakovskiy D, Peregudova M, Sendur MAN, Yazici O, Califano R, Gutierrez Calderon V, de Marinis F, Kim SW, Gadgeel SM, Owen S, Xie J, Sun T, Mehta J, Venkatasubramanian R, Ennis M, Fennema E, Daksh M, Roshak A, Man J, Knoblauch RE, Bauml JM, Baig M, Shah S, Sethi S, Cho BC; MARIPOSA Investigators. Overall Survival with Amivantamab-Lazertinib in EGFR-Mutated Advanced NSCLC. N Engl J Med. 2025 Oct 30;393(17):1681-1693. doi: 10.1056/NEJMoa2503001. Epub 2025 Sep 7.","pmid":"40923797","type":"DERIVED"},{"citation":"Lee SH, Lu S, Hayashi H, Felip E, Spira AI, Girard N, Kim YJ, Ostapenko Y, Danchaivijitr P, Liu B, Alip A, Korbenfeld E, Dias JM, Lee KH, Xiong H, How SH, Cheng Y, Chang GC, Chih-Hsin Yang J, Besse B, Thomas M, Shah S, Baig M, Curtin JC, Zhang J, Xie J, Sun T, Sethi S, Wang M, Fennema E, Daksh M, Ennis M, Bauml JM, Cho BC. Lazertinib Versus Osimertinib in Previously Untreated EGFR-Mutant Advanced NSCLC: A Randomized, Double-Blind, Exploratory Analysis From MARIPOSA. J Thorac Oncol. 2025 Nov;20(11):1655-1668. doi: 10.1016/j.jtho.2025.06.030. Epub 2025 Jul 3.","pmid":"40617394","type":"DERIVED"},{"citation":"Cho BC, Lu S, Felip E, Spira AI, Girard N, Lee JS, Lee SH, Ostapenko Y, Danchaivijitr P, Liu B, Alip A, Korbenfeld E, Mourao Dias J, Besse B, Lee KH, Xiong H, How SH, Cheng Y, Chang GC, Yoshioka H, Yang JC, Thomas M, Nguyen D, Ou SI, Mukhedkar S, Prabhash K, D'Arcangelo M, Alatorre-Alexander J, Vazquez Limon JC, Alves S, Stroyakovskiy D, Peregudova M, Sendur MAN, Yazici O, Califano R, Gutierrez Calderon V, de Marinis F, Passaro A, Kim SW, Gadgeel SM, Xie J, Sun T, Martinez M, Ennis M, Fennema E, Daksh M, Millington D, Leconte I, Iwasawa R, Lorenzini P, Baig M, Shah S, Bauml JM, Shreeve SM, Sethi S, Knoblauch RE, Hayashi H; MARIPOSA Investigators. Amivantamab plus Lazertinib in Previously Untreated EGFR-Mutated Advanced NSCLC. N Engl J Med. 2024 Oct 24;391(16):1486-1498. doi: 10.1056/NEJMoa2403614. Epub 2024 Jun 26.","pmid":"38924756","type":"DERIVED"},{"citation":"Cho BC, Felip E, Hayashi H, Thomas M, Lu S, Besse B, Sun T, Martinez M, Sethi SN, Shreeve SM, Spira AI. MARIPOSA: phase 3 study of first-line amivantamab + lazertinib versus osimertinib in EGFR-mutant non-small-cell lung cancer. Future Oncol. 2022 Feb;18(6):639-647. doi: 10.2217/fon-2021-0923. Epub 2021 Dec 16.","pmid":"34911336","type":"DERIVED"}],"start_date":{"date":"2020-09-30","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer","url":"https://clinicaltrials.gov/study/NCT04487080"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/mariposa-nct04487080"}