{"commentary":{"count":95,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":69,"youtube":13,"podcast":11,"x_video":2},"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04077463\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"Chrysalis-2","nct_id":"NCT04077463","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=chrysalis-2-nct04077463. 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":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":"Chrysalis-2","arms":[{"description":"Participants will receive Lazertinib monotherapy orally once daily (QD) in 21-day cycles until documented evidence of disease progression, unacceptable toxicity, noncompliance, or withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first. The subsequent doses of Lazertinib will be assigned by the Study Evaluation Team (SET) according to the dose escalation strategy by Bayesian logistic regression model (BLRM).","label":"Phase 1 (monotherapy dose escalation): Lazertinib","type":"EXPERIMENTAL"},{"description":"Participants will receive Lazertinib and Amivantamab, after the safety of RP2D of Lazertinib is confirmed in the Phase 1, in 28-day cycles until documented evidence of disease progression, unacceptable toxicity, noncompliance, or withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first. This phase will start enrolling participants after the safety of Amivantamab is confirmed in Japanese participants in Study 61186372EDI1001 (NCT02609776).","label":"Phase 1b (combination): Lazertinib and Amivantamab","type":"EXPERIMENTAL"},{"description":"Participants will receive Lazertinib starting dose administered orally once daily (QD) in combination with Amivantamab, and doses of platinum-based chemotherapy (carboplatin and pemetrexed) per standard of care according to local guidance in a 21-day cycle for 4 cycles followed by maintenance with Lazertinib, Amivantamab and pemetrexed until disease progression or unacceptable toxicities.","label":"Phase 1b (combination): Lazertinib, Amivantamab and Platinum-doublet Chemotherapy (LACP)","type":"EXPERIMENTAL"},{"description":"This cohort A will further characterize the safety, tolerability, and preliminary antitumor activity of Lazertinib and Amivantamab based combinations within specific NSCLC population \"who have progressed after osimertinib and subsequent platinum-based chemotherapy, and platinum-based chemotherapy regimen as the last line of therapy prior to study enrollment. Prior use of first or second generation EGFR TKI is allowed if administered prior to osimertinib. Participants will receive at the RP2CD of Lazertinib orally QD and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter.","label":"Phase 1b (expansion) Cohort A: Lazertinib and Amivantamab","type":"EXPERIMENTAL"},{"description":"This Cohort B will further characterize the safety, tolerability and preliminary antitumor activity of Lazertinib and JNJ-61186372 combination in participants previously treated with advanced or metastatic NSCLC with documented primary EGFR Exon 20ins activating mutation. Participants will receive at the RP2CD of Lazertinib orally QD and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter.","label":"Phase 1b (expansion) Cohort B: Lazertinib and Amivantamab","type":"EXPERIMENTAL"},{"description":"This Cohort C will further characterize the safety, tolerability and preliminary antitumor activity of Lazertinib and JNJ-61186372 combination in participants with uncommon EGFR mutations. Participants will receive at the RP2CD of Lazertinib orally QD and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter.","label":"Phase 1b (expansion) Cohort C: Lazertinib and Amivantamab","type":"EXPERIMENTAL"},{"description":"Cohort D will seek to validate one or both potential biomarker strategies (next generation sequencing \\[NGS\\] and Immunohistochemical \\[IHC\\]), previously identified in Cohort E of Study 61186372EDI1001, in participants with osimertinib-relapsed, but chemotherapy-naive, EGFR Exon19del or L858R mutated NSCLC. Participants will receive at the RP2CD of Lazertinib orally QD and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter.","label":"Phase 1b (expansion) Cohort D: Lazertinib and Amivantamab","type":"EXPERIMENTAL"},{"description":"Participants will receive at the RP2CD of Lazertinib orally QD and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter. Cohort E will seek to validate the immunohistochemical (IHC)-based biomarker strategy, by characterizing the activity of Amivantamab and Lazertinib combination in biomarker-positive participants with osimertinib-relapsed, but chemotherapy-naïve, EGFR Exon19del or L858R mutated NSCLC. In addition, Cohort E will seek to collect prospective data to confirm that prophylactic anticoagulation safely and effectively decreases the incidence of VTE events for patients treated with the combination of Amivantamab and Lazertinib, using Cohort F as reference.","label":"Phase 1b (expansion) Cohort E: Lazertinib and Amivantamab","type":"EXPERIMENTAL"},{"description":"Participants will receive Amivantamab monotherapy once weekly (QW) for 4 weeks, then every 2 weeks thereafter. Cohort F will seek to validate the IHC-based biomarker strategy, previously identified in Cohort D, by characterizing the activity of JNJ-61186372 monotherapy (Cohort F) in biomarker-positive participants with osimertinib-relapsed, but chemotherapy-naïve, EGFR Exon19del or L858R mutated NSCLC.","label":"Phase 1b (expansion) Cohort F: Amivantamab Monotherapy","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2028-03-27","type":"ESTIMATED"},"conditions":["Carcinoma, Non-Small-Cell Lung"],"enrollment":{"count":701,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Lazertinib","type":"DRUG"},{"name":"Amivantamab","type":"DRUG"},{"name":"Carboplatin","type":"DRUG"},{"name":"Pemetrexed","type":"DRUG"}],"last_update":"2026-07-06","lead_sponsor":"Janssen Research & Development, LLC","official_title":"An Open-label Phase 1/1b Study to Evaluate the Safety and Pharmacokinetics of JNJ-73841937 (Lazertinib), a Third Generation EGFR-TKI, as Monotherapy or in Combinations With JNJ-61186372, a Human Bispecific EGFR and cMet Antibody in Participants With Advanced Non-Small Cell Lung Cancer","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2027-02-12","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Percentage of Participants with Dose-Limiting Toxicity (DLT) (Phase 1)","timeFrame":"Until the end of first cycle (21 days for Phase 1)"},{"measure":"Percentage of Participants with Dose-Limiting Toxicity (DLT) (Phase 1b)","timeFrame":"Until the end of first cycle (28 days for Phase 1b)"},{"measure":"Overall Response Rate (ORR) (Phase 1b Expansion Cohorts A-D)","timeFrame":"Up to 2.5 years"},{"measure":"Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability (Phase 1b Expansion Cohorts A-E)","timeFrame":"Up to 2.5 years"},{"measure":"Percentage of Participants with DLT (Phase 1b combination Lazertinib, Amivantamab, Platinum-doublet chemotherapy [LACP])","timeFrame":"Until the end of first cycle (21 days for Phase 1b combination LACP)"},{"measure":"Number of Participants with AEs as a Measure of Safety and Tolerability (Phase 1b combination LACP)","timeFrame":"Up to 2.5 years"},{"measure":"Overall Response Rate (ORR) per RECIST version 1.1 (v1.1) with NGS Analysis of Circulating Tumor ctDNA, IHC Analysis of EGFR and MET Expression (Phase 1b Expansion Cohort D)","timeFrame":"Up to 2.5 years"},{"measure":"ORR Among Participants with MET3+ Staining on Greater Than or Equal to (>=)25 Percent (%) of Tumor Cells (Phase 1b Expansion Cohorts E and F)","timeFrame":"Up to 2.5 years"},{"measure":"Duration of Response (DOR) Among Participants with MET3+ Staining on >=25% of Tumor Cells (Phase 1b Expansion Cohorts E and F)","timeFrame":"Up to 2.5 years"},{"measure":"Clinical Benefit Rate (CBR) Among Participants with MET3+ Staining on >=25% of Tumor Cells (Phase 1b Expansion Cohorts E and F)","timeFrame":"Up to 2.5 years"}],"references":[{"citation":"Besse B, Goto K, Wang Y, Lee SH, Marmarelis ME, Ohe Y, Bernabe Caro R, Kim DW, Lee JS, Cousin S, Ichihara E, Li Y, Paz-Ares L, Ono A, Sanborn RE, Watanabe N, de Miguel MJ, Helissey C, Shu CA, Spira AI, Tomasini P, Yang JC, Zhang Y, Felip E, Griesinger F, Waqar SN, Calles A, Neal JW, Baik CS, Janne PA, Shreeve SM, Curtin JC, Patel B, Gormley M, Lyu X, Chen J, Chu PL, Mahoney J, Trani L, Bauml JM, Thayu M, Knoblauch RE, Cho BC. Amivantamab Plus Lazertinib in Patients With EGFR-Mutant NSCLC After Progression on Osimertinib and Platinum-Based Chemotherapy: Results From CHRYSALIS-2 Cohort A. J Thorac Oncol. 2025 May;20(5):651-664. doi: 10.1016/j.jtho.2024.12.029. Epub 2025 Jan 2.","pmid":"39755170","type":"DERIVED"}],"start_date":{"date":"2019-09-04","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer","url":"https://clinicaltrials.gov/study/NCT04077463"},"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/chrysalis-2-nct04077463"}