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ACTIVE NOT RECRUITING
NCT05908734
PHASE1/PHASE2

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

71

Start Date

2023-05-18

Completion Date

2027-03-31

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

Cetrelimab

Cetrelimab will be administered as IV infusion.

DRUG

Amivantamab

Amivantamab will be administered as IV infusion.

Locations (43)

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 Ankara Onkoloji Egitim ve Arastirma Hastanesi

Ankara, Turkey (Türkiye)

Ankara Bilkent Sehir Hastanesi

Ankara, 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 Universitesi Egitim Ve Arastırma Hastanesi

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