A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer

• Status: Recruiting
• Trial end date: 2025-09-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to identify the recommended Phase 2 (combination) dose (RP2CD) of the amivantamab and cetrelimab combination therapy in participants with non-small cell lung cancer (NSCLC) in Phase 1 (combination dose selection); and to evaluate the antitumor effect of the combination at the selected RP2CD in participants with NSCLC characterized by epidermal growth factor receptor (EGFR) exon19del or exon 21 leucine 858 to arginine substitution (L858R) mutations, who have progressed on or after prior standard of care therapy with a 3rd generation tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy, in the Phase 2 (expansion).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Amivantamab-vmjw

Criteria

Inclusion Criteria:

• Participant must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) (any histology), and must have metastatic NSCLC at the time of enrollment

• Participant's tumor must have an epidermal growth factor receptor (EGFR) exon19del or exon 21 leucine 858 to arginine substitution (L858R) mutation

• Participant must have had disease progression on or after prior standard of care therapy with a 3rd generation EGFR TKI and after platinum-based chemotherapy

• Participant must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, that has not been previously irradiated

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

• Participant has an uncontrolled illness, including but not limited to: a. Uncontrolled diabetes, b. Ongoing or active infection (includes infection requiring treatment with antimicrobial therapy [participants will be required to complete antibiotics 1 week prior to starting study treatment] or diagnosed or suspected viral infection), c. Active bleeding diathesis, d. Impaired oxygenation requiring continuous oxygen supplementation, e. Psychiatric illness or any other circumstances (including social circumstances) that would limit compliance with study requirements

• Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening

• Has an active autoimmune disease or a documented history of autoimmune disease that requires systemic steroids or immunosuppressive agents

• Participant has received radiotherapy for palliative purposes less than 14 days prior to the first dose of study treatment

• Participant has a. (or has a history of) leptomeningeal disease (carcinomatous meningitis), b. spinal cord compression not definitively treated with surgery or radiation