Chrysalis-2

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

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

Phase

Phase 1

Status

Active not recruiting

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Lazertinib; Amivantamab; Carboplatin; Pemetrexed

Arms

• Phase 1 (monotherapy dose escalation): Lazertinib · Experimental
• Phase 1b (combination): Lazertinib and Amivantamab · Experimental
• Phase 1b (combination): Lazertinib, Amivantamab and Platinum-doublet Chemotherapy (LACP) · Experimental
• Phase 1b (expansion) Cohort A: Lazertinib and Amivantamab · Experimental
• Phase 1b (expansion) Cohort B: Lazertinib and Amivantamab · Experimental
• Phase 1b (expansion) Cohort C: Lazertinib and Amivantamab · Experimental
• Phase 1b (expansion) Cohort D: Lazertinib and Amivantamab · Experimental
• Phase 1b (expansion) Cohort E: Lazertinib and Amivantamab · Experimental
• Phase 1b (expansion) Cohort F: Amivantamab Monotherapy · Experimental

Enrollment

701

Primary outcomes

• Percentage of Participants with Dose-Limiting Toxicity (DLT) (Phase 1)
• Percentage of Participants with Dose-Limiting Toxicity (DLT) (Phase 1b)
• Overall Response Rate (ORR) (Phase 1b Expansion Cohorts A-D)
• Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability (Phase 1b Expansion Cohorts A-E)
• Percentage of Participants with DLT (Phase 1b combination Lazertinib, Amivantamab, Platinum-doublet chemotherapy [LACP])
• Number of Participants with AEs as a Measure of Safety and Tolerability (Phase 1b combination LACP)
• 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)
• ORR Among Participants with MET3+ Staining on Greater Than or Equal to (>=)25 Percent (%) of Tumor Cells (Phase 1b Expansion Cohorts E and F)
• Duration of Response (DOR) Among Participants with MET3+ Staining on >=25% of Tumor Cells (Phase 1b Expansion Cohorts E and F)
• Clinical Benefit Rate (CBR) Among Participants with MET3+ Staining on >=25% of Tumor Cells (Phase 1b Expansion Cohorts E and F)

Sponsor

Janssen Research & Development, LLC

Start

Sep 4, 2019

Primary completion

Feb 12, 2027 (estimated)

Results posted

No

Registry record

NCT04077463 · updated Jul 6, 2026

• 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. PubMed 39755170