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Clinical Trials in the UK / NCT05908734
Active, not recruiting Phase 1/2

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

NCT05908734 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 1/2
Started
2023-05-18
Last updated
2026-07-06

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Investigational drug(s) / intervention(s)

CetrelimabAmivantamab

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)

Trial sites (44)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT05908734 on ClinicalTrials.gov ↗ ← All trials in the UK