Active Not RecruitingPhase 1 / Phase 2NCT05908734

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

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 on the basis of epidermal growth factor receptor (EGFR) and Programmed-cell death Ligand (PD-L)1 status, in the Phase 2 (expansion).

Checked against the public recordLast updated Jul 6, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 1 / Phase 2
U.S. locations44
SponsorJanssen Research & Development, LLC
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Janssen Research & Development, LLC
Interventions being studied
Drug: Cetrelimab; Drug: Amivantamab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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: Phase 1 (Combination Dose Selection) Cohort; Metastatic NSCLC progressed on or after standard of care systemic anti-cancer therapy and participant is declining other systemic treatment options, if any;1. Participants without known mutations must have had disease progression on, or have intolerance to, prior platinum-based chemotherapy and PD-(L)1-targeted immunotherapy given concurrently or sequentially, OR 2. Participants with NSCLC characterized by known driver mutations must have had disease progression on, or have intolerance to, appropriate targeted therapies as per local standard of care. Participants may have received prior therapy with amivantamab as long as discontinuation was not due to toxicity. Participants with EGFR mutation must not have had an anti-PD-1/PD-L1 therapy, Phase 2 Expansion Cohorts; Cohort A: Participant's tumor must have an EGFR exon19del or L858R mutation, as determined by local molecular testing, Cohort B: Participants must have tumors lacking known primary driver mutations and must have PD-L1 expression of greater than or equal to (\>=)50 percentage (%), per local testing, and are treatment-naïve in the metastatic setting * 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • City of HopeDuarte, California
  • City of Hope Orange County Lennar Foundation Cancer CenterIrvine, California
  • Cancer and Blood Specialty ClinicLos Alamitos, California
  • Providence Portland Medical CenterPortland, Oregon
  • Providence Oncology and Hematology Care Clinic WestsidePortland, Oregon
  • MD Anderson Cancer CenterHouston, Texas
  • Virginia Cancer SpecialistsFairfax, Virginia
  • Fundacao Pio XIIBarretos
  • Cetus OncologiaBelo Horizonte
  • PERSONAL Oncologia de Precisao e PersonalizadaBelo Horizonte
  • CIONC Centro Integrado de Oncologia de CuritibaCuritiba
  • Hospital do Cancer de LondrinaLondrina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 6, 2026. Always confirm current availability with the study team.

View original record ↗