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New drug duo targets tough lung cancer in early trial

NCT ID NCT05908734

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study tests a combination of two drugs, amivantamab and cetrelimab, in people with advanced non-small cell lung cancer that has spread. The goal is to find the safest dose and see if the combo can shrink tumors. About 71 participants will take part in this early-stage trial.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

71 people

The number who actually took part.

Started

May 2023

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Adana City Hospital

    Adana, 01170, Turkey (Türkiye)

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800, Turkey (Türkiye)

  • Ankara Bilkent Sehir Hastanesi 1

    Ankara, 06800, Turkey (Türkiye)

  • Aou San Luigi Gonzaga

    Orbassano, 10043, Italy

  • Bakirkoy Sadi Konuk Training and Research Hospital

    Istanbul, 34147, Turkey (Türkiye)

  • CIONC Centro Integrado de Oncologia de Curitiba

    Curitiba, 80810 050, Brazil

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720, United States

  • Centro Ricerche Cliniche di Verona S r l

    Verona, 37134, Italy

  • Cetus Oncologia

    Belo Horizonte, 30110 022, Brazil

  • City of Hope

    Duarte, California, 91010, United States

  • City of Hope Orange County Lennar Foundation Cancer Center

    Irvine, California, 92618, United States

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

    Ankara, 06200, Turkey (Türkiye)

  • European Institute of Oncology

    Milan, 20141, Italy

  • Freeman Hospital

    Newcastle, NE7 7DN, United Kingdom

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900, Brazil

  • Fundacao Pio XII

    Barretos, 14784 400, Brazil

  • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722, Turkey (Türkiye)

  • Hosp Univ Vall D Hebron

    Barcelona, 08035, Spain

  • Hosp. Gral. Univ. de Alicante

    Alicante, 03010, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Univ. Quiron Dexeus

    Barcelona, 8028, Spain

  • Hosp. Virgen Macarena

    Seville, 41009, Spain

  • Hospital Nossa Senhora da Conceicao S A

    Porto Alegre, 91350 200, Brazil

  • Hospital Santa Izabel Santa Casa de Misericordia da Bahia

    Salvador, 40050-410, Brazil

  • Hospital Umum Sarawak

    Kuching, 93586, Malaysia

  • Hospital do Cancer de Londrina

    Londrina, 86015 520, Brazil

  • INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp z o o

    Lublin, 20 609, Poland

  • Imperial College London and Imperial College Healthcare NHS Trust

    London, W6 8RF, United Kingdom

  • Instituto Valenciano de Oncologia

    Valencia, 46009, Spain

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Medicana International Izmir

    Izmir, 35170, Turkey (Türkiye)

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02 781, Poland

  • PERSONAL Oncologia de Precisao e Personalizada

    Belo Horizonte, 30130 090, Brazil

  • Providence Oncology and Hematology Care Clinic Westside

    Portland, Oregon, 97225, United States

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Royal Marsden Hospital

    Sutton, SM2 5PT, United Kingdom

  • Sakarya Universitesi Egitim Ve Arastırma Hastanesi

    Sakarya, 54100, Turkey (Türkiye)

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • University Malaya Medical Centre

    Kuala Lumpur, 59100, Malaysia

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow

    Poznan, 60 569, Poland

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