{"entity":{"id":"nct05388669","kind":"trial","name":"A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)","aka":["PALOMA-3"],"tldr":"A phase 3 trial of Lazertinib in non-small-cell lung cancer and small-cell lung cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer is a phase 3 interventional study registered as NCT05388669 by Janssen Research & Development, LLC, with 418 participants enrolled, started 2022-08-05 and due to reach its primary completion in 2024-01-03. Interventions recorded: Lazertinib, Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF), Amivantamab Intravenous. Conditions listed: Advanced or Metastatic Non-small Cell Lung Cancer. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05388669","url":"https://clinicaltrials.gov/study/NCT05388669"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","egfr-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["lazertinib"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05388669","phase":"3","setting":"A Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy","sponsor":"Janssen Research & Development, LLC","started":"2022-08-05","startedType":"actual","yearReported":2026,"enrolled":418,"enrolledBasis":"registry","outcomes":[{"endpoint":"For All Regions Other Than the European Union (EU) and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State","primary":true,"unit":"micrograms per milliliters (mcg/ml)","arms":[{"name":"Arm A: Lazertinib With Amivantamab SC-CF","n":98,"value":206,"note":"geometric CV 39.1%; Figures from the ClinicalTrials.gov results section (first posted 2026-02-02), not from a publication"},{"name":"Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion","n":98,"value":144,"note":"geometric CV 41.5%"}],"source":"https://clinicaltrials.gov/study/NCT05388669?tab=results"}]},"route":"/trials/nct05388669/","neighbours":{"cancer":[{"id":"egfr-mutant-nsclc","kind":"cancer","name":"EGFR-mutated non-small-cell lung cancer","route":"/cancers/egfr-mutant-nsclc/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"sclc","kind":"cancer","name":"Small-cell lung cancer","route":"/cancers/sclc/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"lazertinib","kind":"drug","name":"Lazertinib","route":"/drugs/lazertinib/"}],"company":[{"id":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"}]}}