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NCT07680764PHASE2Recruiting

A Study To Assess the Safety, Tolerability, and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Bristol-Myers Squibb

Start Date

8/15/2026

Completion Date

9/15/2030

Summary

The purpose of this study is to assess the safety, tolerability, and efficacy of Imzokitug in combination with Pumitamig and Platinum-Doublet Chemotherapy (PDCT) versus Pumitamig and PDCT as first-line treatment for participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria * Participants must have histologically confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) (squamous or non-squamous) or recurrent unresectable disease per the American joint committee on cancer (AJCC) Staging System 9th edition. * Participants must have no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease. * Tumor tissue (fresh or archival) obtained within 5 months of enrollment (signing of informed consent) for each participant must be submitted by the site. * Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1. * Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Exclusion Criteria * Participants must not have any documented actionable genomic alterations (AGAs) for which first line approved targeted therapies are indicated. * Participants must not have prior treatment with immuno-oncology therapies. * Participants must not have untreated central nervous system (CNS) metastases. * Other protocol-defined Inclusion/Exclusion criteria apply.

Interventions

DRUG

Pumitamig

DRUG

Imzokitug

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Conditions

Locally Advanced Non-Small Cell Lung Cancer (NSCLC)Metastatic Non-Small Cell Lung Cancer (NSCLC)

Locations

Local Institution - 0170

Athens, Georgia 30607

United States

Local Institution - 0034

Lexington, Kentucky 40503

United States

Local Institution - 0171

Lexington, Kentucky 40509

United States

Local Institution - 0123

Baltimore, Maryland 21224

United States

Local Institution - 0180

Hattiesburg, Mississippi 39401

United States

Nebraska Cancer Specialists

Grand Island, Nebraska 68803

United States

Oncology Hematology West PC

Omaha, Nebraska 68130

United States

Local Institution - 0080

New York, New York 10021

United States

Local Institution - 0105

Nashville, Tennessee 37212

United States

Local Institution - 0095

Houston, Texas 77030

United States

Local Institution - 0135

Madison, Wisconsin 53792

United States

Local Institution - 0092

Viedma, Río Negro Province R8500ACE

Argentina

Local Institution - 0082

Rosario, Santa Fe Province 2000

Argentina

Local Institution - 0094

Buenos Aires, C1426ANZ

Argentina

Local Institution - 0074

Gosford, New South Wales 2250

Australia

Local Institution - 0134

Westmead, New South Wales 2145

Australia

Local Institution - 0167

Greenslopes, Queensland 4120

Australia

Local Institution - 0100

Heidelberg, Victoria 3084

Australia

Local Institution - 0048

Perth, Western Australia 6150

Australia

Local Institution - 0003

Natal/RN, Rio Grande do Norte 59062-000

Brazil

Local Institution - 0006

Porto Alegre, Rio Grande do Sul 91610-000

Brazil

Local Institution - 0005

Barretos, São Paulo 14784

Brazil

Local Institution - 0001

São Paulo, 01246-000

Brazil

Local Institution - 0081

Santiago, Santiago Metropolitan 7500713

Chile

Local Institution - 0149

Santiago, Santiago Metropolitan 8420383

Chile

Local Institution - 0084

Viña del Mar, Valparaiso 2520598

Chile

Local Institution - 0038

Beijing, Beijing Municipality 100142

China

Local Institution - 0138

Fuzhou, Fujian 350014

China

Local Institution - 0050

Wuhan, Hubei 430030

China

Local Institution - 0147

Nanjing, Jiangsu 210029

China

Local Institution - 0140

Shanghai, Shanghai Municipality 200030

China

Local Institution - 0169

Shanghai, Shanghai Municipality 200032

China

Local Institution - 0144

Chengdu, Sichuan 610213

China

Local Institution - 0137

Hangzhou, Zhejiang 310016

China

Local Institution - 0131

Nice, Alpes-Maritimes 6100

France

Local Institution - 0110

Marseille, Bouches-du-Rhône 13385

France

Local Institution - 0087

Montpellier, Languedoc-Roussillon 34070

France

Local Institution - 0119

Villejuif, Val-de-Marne 94800

France

Local Institution - 0047

Grenoble, 38043 Cedex 09

France

Local Institution - 0109

Paris, 75014

France

Local Institution - 0085

Saint-Herblain, 44800

France

Local Institution - 0019

Paris, Île-de-France Region 75005

France

Local Institution - 0126

Stuttgart, Baden-Wurttemberg 70376

Germany

Local Institution - 0156

Marburg, Hesse 35043

Germany

Local Institution - 0152

Homburg, Saarland 66424

Germany

Local Institution - 0065

Cologne, 51109

Germany

Local Institution - 0042

Haile, 06120

Germany

Local Institution - 0125

Hessen, 60590

Germany

Local Institution - 0128

Misterbianco, Catania 95045

Italy

Local Institution - 0043

Bari, 70124

Italy

Local Institution - 0148

Bergamo, 24128

Italy

Local Institution - 0159

Milan, 20142

Italy

Local Institution - 0014

Ravenna, 48121

Italy

Local Institution - 0011

Rozzano (MI), 20089

Italy

Local Institution - 0114

Florești, Cluj 407280

Romania

Local Institution - 0113

Timișoara, Timiș County 300239

Romania

Local Institution - 0076

Bucharest,  022328

Romania

Local Institution - 0008

Cluj-Napoca, 400015

Romania

Local Institution - 0075

Craiova, 200347

Romania

Local Institution - 0115

Iași, 700106

Romania

Local Institution - 0116

Iași, 700483

Romania

Local Institution - 0132

Badalona, Barcelona 8916

Spain

Local Institution - 0162

Seville, Seville 41013

Spain

Local Institution - 0027

Barcelona, 08035

Spain

Local Institution - 0068

Barcelona, 08041

Spain

Local Institution - 0163

Barcelona, 8036

Spain

Local Institution - 0041

Madrid, 28041

Spain

Local Institution - 0010

Majadahonda, 28222

Spain

Local Institution - 0020

Málaga, 29010

Spain

Local Institution - 0035

London, Greater London SE19RT

United Kingdom

Local Institution - 0037

Guildford, GU2 7XX

United Kingdom