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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

Full criteria on ClinicalTrials.gov

Sites (40)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Fundacao Pio XII
Coordinator of this site? Confirm its status
BarretosBrazilUnknown status
PERSONAL Oncologia de Precisao e Personalizada
Coordinator of this site? Confirm its status
Belo HorizonteBrazilUnknown status
Cetus Oncologia
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Belo HorizonteBrazilUnknown status
CIONC-Centro Integrado de Oncologia de Curitiba
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CuritibaBrazilUnknown status
Hospital do Câncer de Londrina
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LondrinaBrazilUnknown status
Hospital Nossa Senhora da Conceicao S A
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Porto AlegreBrazilUnknown status
Hospital Santa Izabel, Santa Casa de Misericordia da Bahia
Coordinator of this site? Confirm its status
SalvadorBrazilUnknown status
Fundacao Antonio Prudente A C Camargo Cancer Center
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São PauloBrazilUnknown status
Hospital General Universitario Dr. Balmis
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AlicanteSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Fundación Instituto Valenciano de Oncología
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ValenciaSpainCompleted
Imperial College London and Imperial College Healthcare NHS Trust
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LondonUnited KingdomUnknown status
Freeman Hospital
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NewcastleUnited KingdomUnknown status
Royal Marsden Hospital
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SuttonUnited KingdomUnknown status
Istituto Europeo di Oncologia s.r.l
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MilanItalyCompleted
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyCompleted
Centro Ricerche Cliniche di Verona s.r.l.
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VeronaItalyCompleted
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
University Malaya Medical Centre
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Kuala LumpurMalaysiaUnknown status
Hospital Umum Sarawak
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KuchingMalaysiaUnknown status
INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp z o o
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LublinPolandCompleted
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow
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PoznanPolandCompleted
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandCompleted
City of Hope
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DuarteUnited StatesUnknown status
Virginia Cancer Specialists
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FairfaxUnited StatesUnknown status
MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
City of Hope Orange County Lennar Foundation Cancer Center
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IrvineUnited StatesUnknown status
Cancer and Blood Specialty Clinic
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Los AlamitosUnited StatesUnknown status
Providence Oncology and Hematology Care Clinic - Westside
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PortlandUnited StatesUnknown status
Providence Portland Medical Center
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PortlandUnited StatesUnknown status
Adana City Hospital
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AdanaTurkey (Türkiye)Unknown status
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
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AnkaraTurkey (Türkiye)Unknown status
Ankara Bilkent Sehir Hastanesi 1
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AnkaraTurkey (Türkiye)Unknown status
Ankara Bilkent Sehir Hastanesi
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AnkaraTurkey (Türkiye)Unknown status
Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
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IstanbulTurkey (Türkiye)Unknown status
Bakirkoy Sadi Konuk Training and Research Hospital
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IstanbulTurkey (Türkiye)Unknown status
Medicana International Izmir
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IzmirTurkey (Türkiye)Unknown status
Sakarya Universitesi Egitim Ve Arastırma Hastanesi
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SakaryaTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.