Cetrelimab: Cetrelimab will be administered as IV infusion.
Amivantamab: Amivantamab will be administered as IV infusion.
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Phase 1: Number of Participants with Adverse events (AEs) by Severity — Up to 2 years 3 months An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs) — Up to Cycle 1 (Day 1 through Day 28) The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, hematological toxicity, pulmonary toxicity, liver enzyme elevation, treatment delay greater than (\>) 28 days due to unresolved toxicity, or immune-related toxicity requiring the use of therapies in excess of corticosteroids.
Phase 2: Objective Response Rate — Up to 2 years 3 months ORR is defined as the percentage of participants who achieve either a confirmed partial response (PR) or complete response (CR), using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as per investigator assessment.
Trial sites (44)
Facility
City
Region
Status
City of Hope
Duarte
California
City of Hope Orange County Lennar Foundation Cancer Center
Irvine
California
Cancer and Blood Specialty Clinic
Los Alamitos
California
Providence Portland Medical Center
Portland
Oregon
Providence Oncology and Hematology Care Clinic Westside
Portland
Oregon
MD Anderson Cancer Center
Houston
Texas
Virginia Cancer Specialists
Fairfax
Virginia
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 1
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)
+ 4 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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