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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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 facts

Study ID

NCT05908734

Run by

Janssen Research & Development, LLC

People needed

71

Starts

2023-05-18

Expected to finish

2027-03-31

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• City of Hope — Duarte, California, United States
• City of Hope Orange County Lennar Foundation Cancer Center — Irvine, California, United States
• Cancer and Blood Specialty Clinic — Los Alamitos, California, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• Providence Oncology and Hematology Care Clinic Westside — Portland, Oregon, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States
• Fundacao Pio XII — Barretos, Brazil
• Cetus Oncologia — Belo Horizonte, Brazil
• PERSONAL Oncologia de Precisao e Personalizada — Belo Horizonte, Brazil
• CIONC Centro Integrado de Oncologia de Curitiba — Curitiba, Brazil
• Hospital do Cancer de Londrina — Londrina, Brazil
• Hospital Nossa Senhora da Conceicao S A — Porto Alegre, Brazil
• Hospital Santa Izabel Santa Casa de Misericordia da Bahia — Salvador, Brazil
• Fundacao Antonio Prudente A C Camargo Cancer Center — São Paulo, Brazil
• European Institute of Oncology — Milan, Italy
• ASST Grande Ospedale Metropolitano Niguarda — Milan, Italy
• Aou San Luigi Gonzaga — Orbassano, Italy
• Centro Ricerche Cliniche di Verona S r l — Verona, Italy
• University Malaya Medical Centre — Kuala Lumpur, Malaysia
• Hospital Umum Sarawak — Kuching, Malaysia
• INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp z o o — Lublin, Poland
• Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow — Poznan, Poland
• Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy — Warsaw, Poland
• Seoul National University Hospital — Seoul, South Korea

Full record on ClinicalTrials.gov

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