ClinicalTrialsFinder

RecruitingPhase 2NCT06946797

A Study to Evaluate Two Dosing Regimens of Subcutaneous Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Previously Untreated Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC)

A Phase 2, Open-label, Randomized Trial to Evaluate Two Dosing Regimens of Subcutaneous Formulation of Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Previously Untreated Metastatic or Recurrent NSCLC

Sponsor

Bristol-Myers Squibb

Enrollment

76 participants

Start Date

Sep 19, 2025

Study Type

INTERVENTIONAL

Summary

The purpose of this study is to evaluate two dosing regimens of subcutaneous Nivolumab in combination with intravenous Ipilimumab and chemotherapy in participants with previously untreated metastatic or recurrent Non-Small Cell Lung Cancer (NSCLC)

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different dosing schedules of a subcutaneous (under-the-skin injection) form of nivolumab combined with ipilimumab and chemotherapy for people with advanced or recurrent non-small cell lung cancer (NSCLC) who have not yet received systemic treatment. **You may be eligible if...** - You have confirmed stage IV (metastatic) or recurrent non-small cell lung cancer (either squamous or non-squamous type) - You have not yet received systemic treatment (chemotherapy, targeted therapy, or immunotherapy) for your advanced disease - You are in reasonably good physical condition - You have measurable cancer on imaging scans **You may NOT be eligible if...** - You have already received systemic anti-cancer treatment for advanced disease - You have untreated or unstable brain metastases - You have active autoimmune disease requiring steroids or immunosuppressants - You have significant heart or lung problems that make the treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNivolumab

Specified dose on specified days

DRUGIpilimumab

Specified dose on specified days

DRUGCarboplatin

Specified dose on specified days

DRUGPaclitaxel

Specified dose on specified days

DRUGPemetrexed

Specified dose on specified days

DRUGCisplatin

Specified dose on specified days

Locations(48)

Alaska Oncology and Hematology

Anchorage, Alaska, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Local Institution - 0088

Newport Beach, California, United States

Local Institution - 0063

Boise, Idaho, United States

Saint Alphonsus Regional Medical Center

Boise, Idaho, United States

Beacon Cancer Care

Post Falls, Idaho, United States

Local Institution - 0047

Cleveland, Ohio, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

Hospital Sirio Libanes

Brasília, Federal District, Brazil

Hospital Luxemburgo

Belo Horizonte, Minas Gerais, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo, Brazil

Icesp - Instituto Do Câncer Do Estado de São Paulo

São Paulo, Brazil

Bradfordhill

Santiago, Santiago Metropolitan, Chile

Centre Georges François Leclerc

Dijon, Côte-d'Or, France

Hôpital Foch

Suresnes, Hauts-de-Seine, France

Groupe hospitalier Paris saint Joseph

Paris, Île-de-France Region, France

Thoracic General Hospital of Athens "I Sotiria"

Athens, Attikí, Greece

University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"

Chaïdári, Attikí, Greece

"Theagenio" Cancer Hospital of Thessaloniki

Thessaloniki, Kentrikí Makedonía, Greece

University General Hospital of Larissa

Larissa, Thessalía, Greece

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

Meldola, Emilia-Romagna, Italy

P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale

Udine, Friuli Venezia Giulia, Italy

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Bergamo, Lombardy, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, Italy

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, Italy

Local Institution - 0025

Guadalajara, Jalisco, Mexico

Local Institution - 0058

Monterrey, Nuevo León, Mexico

Local Institution - 0027

Mérida, Yucatán, Mexico

Local Institution - 0024

México, Mexico

Local Institution - 0022

Puebla City, Mexico

Mazowiecki Szpital Onkologiczny

Warsaw, Masovian Voivodeship, Poland

Szpital Specjalistyczny w Prabutach Spolka z o.o.

Prabuty, Pomeranian Voivodeship, Poland

Instytut Centrum Zdrowia Matki Polki

Lodz, Łódź Voivodeship, Poland

Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu"

Bucharest, Bucharest, Romania

SC Radiotherapy Center Cluj SRL

Florești, Cluj, Romania

Centrul de Oncologie "Sfântul Nectarie"

Craiova, Dolj, Romania

Centrul de Diagnostic si Tratament Provita

Bucharest, Romania

Institutul Oncologic Cluj

Cluj-Napoca, Romania

Institutul Regional de Oncologie

Iași, Romania

Local Institution - 0066

Pretoria, Gauteng, South Africa

Wits Clinical Research

Soweto, Gauteng, South Africa

Local Institution - 0009

Sandton, GP, South Africa

Cancercare Rondebosch Oncology

Rondebosch, Western Cape, South Africa

Local Institution - 0070

Adana, Turkey (Türkiye)

Local Institution - 0072

Ankara, Turkey (Türkiye)

Local Institution - 0071

Istanbul, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

NCT06946797