NCT05908734Active, not recruitingPhase 1/2
A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer
A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Cetrelimab Combination Therapy in Metastatic Non-small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 71 (actual)
- First submitted
- 6 Jun 2023
- Start date
- 18 May 2023
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Lung cancer
- NCT number
- NCT05908734
- EU CT number
- 2022-501452-29-00
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 71
- From 18 May 2023 to the primary completion date, 31 Jan 2027
- 40 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (40)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundacao Pio XII Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| PERSONAL Oncologia de Precisao e Personalizada Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
| Cetus Oncologia Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
| CIONC-Centro Integrado de Oncologia de Curitiba Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Hospital do Câncer de Londrina Coordinator of this site? Confirm its status | Londrina | Brazil | Unknown status |
| Hospital Nossa Senhora da Conceicao S A Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital Santa Izabel, Santa Casa de Misericordia da Bahia Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Fundacao Antonio Prudente A C Camargo Cancer Center Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Fundación Instituto Valenciano de Oncología Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Imperial College London and Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Freeman Hospital Coordinator of this site? Confirm its status | Newcastle | United Kingdom | Unknown status |
| Royal Marsden Hospital Coordinator of this site? Confirm its status | Sutton | United Kingdom | Unknown status |
| Istituto Europeo di Oncologia s.r.l Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga Coordinator of this site? Confirm its status | Orbassano | Italy | Completed |
| Centro Ricerche Cliniche di Verona s.r.l. Coordinator of this site? Confirm its status | Verona | Italy | Completed |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| University Malaya Medical Centre Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| Hospital Umum Sarawak Coordinator of this site? Confirm its status | Kuching | Malaysia | Unknown status |
| INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp z o o Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Virginia Cancer Specialists Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| City of Hope Orange County Lennar Foundation Cancer Center Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| Cancer and Blood Specialty Clinic Coordinator of this site? Confirm its status | Los Alamitos | United States | Unknown status |
| Providence Oncology and Hematology Care Clinic - Westside Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Providence Portland Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Adana City Hospital Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Ankara Bilkent Sehir Hastanesi 1 Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Ankara Bilkent Sehir Hastanesi Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Bakirkoy Sadi Konuk Training and Research Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Medicana International Izmir Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
| Sakarya Universitesi Egitim Ve Arastırma Hastanesi Coordinator of this site? Confirm its status | Sakarya | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.