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

NCT ID: NCT05908734

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-18
• Study Completion Date: 2027-03-31

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

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cetrelimab

Intervention Type: DRUG

Cetrelimab will be administered as IV infusion.

Amivantamab

Intervention Type: DRUG

Amivantamab will be administered as IV infusion.

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.

Group Type: EXPERIMENTAL

Cetrelimab

Intervention Type: DRUG

Cetrelimab will be administered as IV infusion.

Amivantamab

Intervention Type: DRUG

Amivantamab will be administered as IV infusion.

Interventions

Cetrelimab

Cetrelimab will be administered as IV infusion.

Intervention Type: DRUG

Amivantamab

Amivantamab will be administered as IV infusion.

Intervention Type: DRUG

Other Intervention Names

JNJ-63723283; JNJ-61186372

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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

Severance Hospital Yonsei University Health System

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Hosp. Gral. Univ. de Alicante

Alicante, , Spain

Hosp Univ Vall D Hebron

Barcelona, , Spain

Hosp. Univ. Quiron Dexeus

Barcelona, , Spain

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Hosp. Virgen Macarena

Seville, , Spain

Instituto Valenciano de Oncologia

Valencia, , Spain

Adana City Hospital

Adana, , Turkey (Türkiye)

Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, , Turkey (Türkiye)

Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Ankara Bilkent City Hospital

Çankaya, , Turkey (Türkiye)

Bakirkoy Sadi Konuk Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

Istanbul, , Turkey (Türkiye)

Medicana International Izmir

Izmir, , Turkey (Türkiye)

Sakarya University Training and Research Hospital

Sakarya, , Turkey (Türkiye)

Imperial College London and Imperial College Healthcare NHS Trust

London, , United Kingdom

Freeman Hospital

Newcastle, , United Kingdom

Royal Marsden Hospital

Sutton, , United Kingdom

Countries

United States; Brazil; Italy; Malaysia; Poland; South Korea; Spain; Turkey (Türkiye); United Kingdom

Other Identifiers

61186372PANSC2002

Identifier Type: OTHER

Identifier Source: secondary_id

2022-501452-29-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR109323

Identifier Type: -

Identifier Source: org_study_id