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

Part of paid clinical trials in Duarte, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05908734
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cetrelimab — DRUG
    Cetrelimab will be administered as IV infusion.
  • Amivantamab — DRUG
    Amivantamab will be administered as IV infusion.

Study Details

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).

Key Dates

Start date
May 18, 2023
Status verified
Jun 2026
Primary completion
Jan 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
71 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 (Combination Dose Selection)
    Participants will receive amivantamab low dose or high dose intravenous (IV) infusion based on body weight from Cycle 1 Day 1, Day 2, and subsequently Day 8, Day 15, and Day 22 and then every 2 weeks from Cycle 2 in combination with cetrelimab IV infusion from Cycle 1 Day 2 (after the Day 2 infusion of amivantamab). Cetrelimab treatment duration will be limited to a maximum of 24 months. Doses will be escalated or de-escalated based on the dose limiting toxicities (DLTs) and the recommended Phase 2 combination dose (RP2CD) will be determined by the study evaluation team (SET). Participants who continue to benefit from study treatment(s), as determined by their investigator, may continue to receive access to study treatment(s) within the study by transferring to a long term extension (LTE) phase.
  • Experimental: Phase 2 (Dose Expansion)
    Participants will receive amivantamab in combination with cetrelimab in Cohorts A and B at the RP2CD determined by the SET in Phase 1. Participants will continue study treatment until disease progression, unacceptable toxicity, or until another criterion for discontinuation of study treatment is met. Cetrelimab treatment duration will be limited to a maximum of 24 months. Participants who continue to benefit from study treatment(s), as determined by their investigator, may continue to receive access to study treatment(s) within the study by transferring to an LTE phase.

Primary Outcome Measure

Phase 1: Number of Participants with Adverse events (AEs) by Severity [ Time Frame: Up to 2 years 3 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
City of Hope Orange County Lennar Foundation Cancer CenterIrvineCalifornia92618-
Cancer and Blood Specialty ClinicLos AlamitosCalifornia90720-
Providence Oncology and Hematology Care Clinic WestsidePortlandOregon97225-
Providence Portland Medical CenterPortlandOregon97213-
MD Anderson Cancer CenterHoustonTexas77030-
Virginia Cancer SpecialistsFairfaxVirginia22031-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CACity of Hope Orange County Lennar Foundation Cancer Center· Irvine, CACancer and Blood Specialty Clinic· Los Alamitos, CAProvidence Oncology and Hematology Care Clinic Westside· Portland, ORProvidence Portland Medical Center· Portland, ORMD Anderson Cancer Center· Houston, TX

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