{"entity":{"id":"nct05663866","kind":"trial","name":"Premedication to Reduce Amivantamab Associated Infusion Related Reactions","aka":[],"tldr":"A phase 2 trial of Dexamethasone, Methotrexate, Amivantamab and Lazertinib in non-small-cell lung cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"Premedication to Reduce Amivantamab Associated Infusion Related Reactions is a phase 2 interventional study registered as NCT05663866 by Janssen Research & Development, LLC, with 68 participants enrolled, started 2023-05-18 and due to reach its primary completion in 2024-03-29. Interventions recorded: Dexamethasone, Montelukast, Methotrexate, Amivantamab and Lazertinib. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05663866","url":"https://clinicaltrials.gov/study/NCT05663866"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["antiemetic-therapy","bispecific-antibody","cytotoxic-chemotherapy"],"targets":[],"drugs":["dexamethasone","methotrexate","amivantamab","lazertinib"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05663866-j-thorac-oncol-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05663866","phase":"2","setting":"Subcutaneous Methotrexate, Oral Dexamethasone or Oral Montelukast for the Prevention of Infusion Related Reaction Associated With Amivantamab, an EGFR-MET Bispecific Antibody, Among Post-osimertinib Treated EGFRm NSCLC; SKIPPirr, a Phase 2 Study","sponsor":"Janssen Research & Development, LLC","started":"2023-05-18","startedType":"actual","yearReported":2025,"enrolled":68,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With Infusion-related Reactions (IRRs) at Cycle 1 Day 1","primary":true,"unit":"%","arms":[{"name":"Cohort A: Dexamethasone 4 Milligrams (mg)","n":6,"value":83.3,"note":"95% CI 35.9 to 99.6; Figures from the ClinicalTrials.gov results section (first posted 2025-10-20), not from a publication"},{"name":"Cohort A2: Dexamethasone 8 mg","n":40,"value":22.5,"note":"95% CI 10.8 to 38.5"},{"name":"Cohort B: Montelukast 10 mg","n":15,"value":66.7,"note":"95% CI 38.4 to 88.2"},{"name":"Cohort C: Methotrexate 25 mg","n":6,"value":83.3,"note":"95% CI 35.9 to 99.6"}],"source":"https://clinicaltrials.gov/study/NCT05663866?tab=results"}]},"route":"/trials/nct05663866/","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/"}],"technology":[{"id":"antiemetic-therapy","kind":"technology","name":"Antiemetics for chemotherapy-induced nausea and vomiting","route":"/technologies/antiemetic-therapy/"},{"id":"bispecific-antibody","kind":"technology","name":"Bispecific antibodies","route":"/technologies/bispecific-antibody/"},{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"amivantamab","kind":"drug","name":"Amivantamab","route":"/drugs/amivantamab/"},{"id":"dexamethasone","kind":"drug","name":"Dexamethasone","route":"/drugs/dexamethasone/"},{"id":"lazertinib","kind":"drug","name":"Lazertinib","route":"/drugs/lazertinib/"},{"id":"methotrexate","kind":"drug","name":"Methotrexate","route":"/drugs/methotrexate/"}],"company":[{"id":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"}],"paper":[{"id":"paper-nct05663866-j-thorac-oncol-2025","kind":"paper","name":"Preventing Infusion-Related Reactions With Intravenous Amivantamab-Results From SKIPPirr, a Phase 2 Study: A Brief Report","route":"/key-papers/paper-nct05663866-j-thorac-oncol-2025/"}]}}