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Combination therapy for metastatic non-small cell lung cancer

A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Cetrelimab Combination Therapy in Metastatic Non-small Cell Lung Cancer

PHASE1; PHASE2 · Janssen Research & Development, LLC · NCT05908734

This study is testing the best dose of a new combination treatment for patients with advanced lung cancer that hasn't responded to other therapies to see how well it works based on their genetic markers.

Quick facts

PhasePHASE1; PHASE2
Study typeInterventional
Enrollment75 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC (industry)
Drugs / interventionsamivantamab, chemotherapy, immunotherapy, radiation, cetrelimab
Locations44 sites (Duarte, California and 43 other locations)
Trial IDNCT05908734 on ClinicalTrials.gov

What this trial studies

This study aims to determine the optimal dose of a combination therapy using amivantamab and cetrelimab for patients with metastatic non-small cell lung cancer (NSCLC). In the first phase, the study will focus on selecting the recommended Phase 2 combination dose, while the second phase will evaluate the effectiveness of this combination based on specific genetic markers like EGFR and PD-L1 status. Participants must have advanced NSCLC that has progressed after standard treatments and are not seeking further systemic options.

Who should consider this trial

Good fit: Ideal candidates are individuals with metastatic non-small cell lung cancer who have progressed after standard therapies and are declining further systemic treatments.

Not a fit: Patients with early-stage non-small cell lung cancer or those who have not yet undergone standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this combination therapy could provide a new treatment option for patients with advanced non-small cell lung cancer.

How similar studies have performed: Other studies have shown promising results with combination therapies in treating non-small cell lung cancer, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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: 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

Where this trial is running

Duarte, California and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Carcinoma, Non-Small-Cell Lung

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.