{"entity":{"id":"nct04538664","kind":"trial","name":"A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions","aka":["PAPILLON"],"tldr":"A phase 3 trial of Amivantamab, Pemetrexed and Carboplatin in non-small-cell lung cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions is a phase 3 interventional study registered as NCT04538664 by Janssen Research & Development, LLC, with 308 participants enrolled, started 2020-10-13 and due to reach its primary completion in 2023-05-03. Interventions recorded: Amivantamab, Pemetrexed and Carboplatin. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04538664","url":"https://clinicaltrials.gov/study/NCT04538664"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["bispecific-antibody","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["amivantamab","pemetrexed","carboplatin"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04538664-n-engl-j-med-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04538664","phase":"3","setting":"A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer","sponsor":"Janssen Research & Development, LLC","started":"2020-10-13","startedType":"actual","yearReported":2024,"enrolled":308,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)","primary":true,"unit":"months","arms":[{"name":"Arm B: Chemotherapy Alone","n":155,"value":6.7,"note":"95% CI 5.59 to 7.33; Figures from the ClinicalTrials.gov results section (first posted 2024-05-29), not from a publication"},{"name":"Arm A: Amivantamab + Chemotherapy","n":153,"value":11.37,"note":"95% CI 9.79 to 13.70"}],"hr":0.395,"ci":[0.296,0.528],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT04538664?tab=results"}]},"route":"/trials/nct04538664/","neighbours":{"cancer":[{"id":"egfr-mutant-nsclc","kind":"cancer","name":"EGFR-mutated non-small-cell lung cancer","route":"/cancers/egfr-mutant-nsclc/"},{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"bispecific-antibody","kind":"technology","name":"Bispecific antibodies","route":"/technologies/bispecific-antibody/"},{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"platinum","kind":"technology","name":"Platinum agents","route":"/technologies/platinum/"}],"drug":[{"id":"amivantamab","kind":"drug","name":"Amivantamab","route":"/drugs/amivantamab/"},{"id":"carboplatin","kind":"drug","name":"Carboplatin","route":"/drugs/carboplatin/"},{"id":"pemetrexed","kind":"drug","name":"Pemetrexed","route":"/drugs/pemetrexed/"}],"company":[{"id":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"}],"paper":[{"id":"paper-nct04538664-n-engl-j-med-2023","kind":"paper","name":"Amivantamab plus Chemotherapy in NSCLC with EGFR Exon 20 Insertions","route":"/key-papers/paper-nct04538664-n-engl-j-med-2023/"}]}}