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RECRUITING
NCT06946797
PHASE2

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)

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

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)

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

76

Start Date

2025-09-19

Completion Date

2028-10-25

Last Updated

2026-03-24

Healthy Volunteers

No

Interventions

DRUG

Nivolumab

Specified dose on specified days

DRUG

Ipilimumab

Specified dose on specified days

DRUG

Carboplatin

Specified dose on specified days

DRUG

Paclitaxel

Specified dose on specified days

DRUG

Pemetrexed

Specified dose on specified days

DRUG

Cisplatin

Specified dose on specified days

Locations (50)

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

Local Institution - 0068

Antofagasta, AN, Chile

Local Institution - 0069

Viña del Mar, Región de Valparaíso, Chile

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, București, 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)