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)

NCT07680764 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: CA052-10002026-525170-19U1111-1333-5867
• Study Type: interventional
• Target: 160
• Locations: 12 countries
• Sites: 73

Brief 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)

Conditions

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

Keywords

Squamous Non-Small Cell Lung Cancer (NSCLC); Non-squamous Non-Small Cell Lung Cancer (NSCLC); Immunotherapy; Bispecific antibody; Imzokitug; Anti-CCR8 monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) by investigator (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1)

  Up to approximately 4 years

Secondary Outcomes (10)

• Number of participants with adverse events (AEs)

  Up to 90 days after discontinuation of study treatment

• Number of participants with serious adverse events (SAEs)

  Up to 90 days after discontinuation of study treatment

• Number of participants with treatment-related AEs

  Up to 90 days after discontinuation of study treatment

• Number of participants with treatment-related SAEs

  Up to 90 days after discontinuation of study treatment

• Number of participants with AEs leading to discontinuation

  Up to 90 days after discontinuation of study treatment

Study Arms (4)

Arm A: Pumitamig + Imzokitug + Histology-based PDCT

EXPERIMENTAL

Drug: Pumitamig; Drug: Imzokitug; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel

Arm B: Pumitamig + Imzokitug + Histology-based PDCT

EXPERIMENTAL

Drug: Pumitamig; Drug: Imzokitug; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel

Arm C: Pumitamig + Imzokitug + Histology-based PDCT

EXPERIMENTAL

Drug: Pumitamig; Drug: Imzokitug; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel

Arm D: Pumitamig + Histology-based PDCT

EXPERIMENTAL

Drug: Pumitamig; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel

Interventions

Imzokitug DRUG

Specified dose on specified days

Also known as: Anti-CCR8, BMS-986340

Arm A: Pumitamig + Imzokitug + Histology-based PDCT; Arm B: Pumitamig + Imzokitug + Histology-based PDCT; Arm C: Pumitamig + Imzokitug + Histology-based PDCT

Pumitamig DRUG

Specified dose on specified days

Also known as: BMS-986545, BNT327, PM8002

Arm A: Pumitamig + Imzokitug + Histology-based PDCT; Arm B: Pumitamig + Imzokitug + Histology-based PDCT; Arm C: Pumitamig + Imzokitug + Histology-based PDCT; Arm D: Pumitamig + Histology-based PDCT

Pemetrexed DRUG

Specified dose on specified days

Arm A: Pumitamig + Imzokitug + Histology-based PDCT; Arm B: Pumitamig + Imzokitug + Histology-based PDCT; Arm C: Pumitamig + Imzokitug + Histology-based PDCT; Arm D: Pumitamig + Histology-based PDCT

Cisplatin DRUG

Specified dose on specified days

Arm A: Pumitamig + Imzokitug + Histology-based PDCT; Arm B: Pumitamig + Imzokitug + Histology-based PDCT; Arm C: Pumitamig + Imzokitug + Histology-based PDCT; Arm D: Pumitamig + Histology-based PDCT

Carboplatin DRUG

Specified dose on specified days

Arm A: Pumitamig + Imzokitug + Histology-based PDCT; Arm B: Pumitamig + Imzokitug + Histology-based PDCT; Arm C: Pumitamig + Imzokitug + Histology-based PDCT; Arm D: Pumitamig + Histology-based PDCT

Paclitaxel DRUG

Specified dose on specified days

Arm A: Pumitamig + Imzokitug + Histology-based PDCT; Arm B: Pumitamig + Imzokitug + Histology-based PDCT; Arm C: Pumitamig + Imzokitug + Histology-based PDCT; Arm D: Pumitamig + Histology-based PDCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (73)

Local Institution - 0183

Washington D.C., District of Columbia, 20016, United States

NOT YET RECRUITING

University Cancer & Blood Center, LLC

Athens, Georgia, 30607, United States

RECRUITING

Local Institution - 0034

Lexington, Kentucky, 40503, United States

NOT YET RECRUITING

Local Institution - 0171

Lexington, Kentucky, 40509, United States

NOT YET RECRUITING

Local Institution - 0123

Baltimore, Maryland, 21224, United States

NOT YET RECRUITING

Local Institution - 0180

Hattiesburg, Mississippi, 39401, United States

NOT YET RECRUITING

Nebraska Cancer Specialists

Grand Island, Nebraska, 68803, United States

RECRUITING

Oncology Hematology West PC

Omaha, Nebraska, 68130, United States

RECRUITING

Local Institution - 0080

New York, New York, 10021, United States

NOT YET RECRUITING

Local Institution - 0176

Columbus, Ohio, 43210, United States

NOT YET RECRUITING

Local Institution - 0095

Houston, Texas, 77030, United States

NOT YET RECRUITING

Local Institution - 0135

Madison, Wisconsin, 53792, United States

NOT YET RECRUITING

Sanatorio Parque Rosario

Rosario, Santa Fe Province, 2000, Argentina

RECRUITING

Instituto Medico Especializado Alexander Fleming

Buenos Aires, C1426ANZ, Argentina

RECRUITING

Clinica Viedma S.A.

Viedma, R8500ACE, Argentina

RECRUITING

Local Institution - 0074

Gosford, New South Wales, 2250, Australia

NOT YET RECRUITING

Local Institution - 0134

Westmead, New South Wales, 2145, Australia

NOT YET RECRUITING

Local Institution - 0167

Greenslopes, Queensland, 4120, Australia

NOT YET RECRUITING

Local Institution - 0100

Heidelberg, Victoria, 3084, Australia

NOT YET RECRUITING

St. John of God Murdoch Hospital

Perth, Western Australia, 6150, Australia

RECRUITING

Local Institution - 0003

Natal/RN, Rio Grande do Norte, 59062-000, Brazil

NOT YET RECRUITING

Local Institution - 0006

Porto Alegre, Rio Grande do Sul, 91610-000, Brazil

NOT YET RECRUITING

Local Institution - 0005

Barretos, São Paulo, 14784, Brazil

NOT YET RECRUITING

Local Institution - 0001

São Paulo, 01246-000, Brazil

NOT YET RECRUITING

Local Institution - 0081

Santiago, Santiago Metropolitan, 7500713, Chile

NOT YET RECRUITING

Local Institution - 0149

Santiago, Santiago Metropolitan, 8420383, Chile

NOT YET RECRUITING

Local Institution - 0084

Viña del Mar, Valparaiso, 2520598, Chile

NOT YET RECRUITING

Local Institution - 0038

Beijing, Beijing Municipality, 100142, China

NOT YET RECRUITING

Local Institution - 0138

Fuzhou, Fujian, 350014, China

NOT YET RECRUITING

Local Institution - 0050

Wuhan, Hubei, 430030, China

NOT YET RECRUITING

Local Institution - 0147

Nanjing, Jiangsu, 210029, China

NOT YET RECRUITING

Local Institution - 0140

Shanghai, Shanghai Municipality, 200030, China

NOT YET RECRUITING

Local Institution - 0169

Shanghai, Shanghai Municipality, 200032, China

NOT YET RECRUITING

Local Institution - 0144

Chengdu, Sichuan, 610213, China

NOT YET RECRUITING

Local Institution - 0137

Hangzhou, Zhejiang, 310016, China

NOT YET RECRUITING

Local Institution - 0131

Nice, Alpes-Maritimes, 6100, France

NOT YET RECRUITING

Local Institution - 0087

Montpellier, Languedoc-Roussillon, 34070, France

NOT YET RECRUITING

Local Institution - 0119

Villejuif, Val-de-Marne, 94800, France

NOT YET RECRUITING

Local Institution - 0047

Grenoble, 38043 Cedex 09, France

NOT YET RECRUITING

Assistance Publique Hôpitaux de Marseille - Hôpital Nord

Marseille, 13915, France

RECRUITING

Local Institution - 0109

Paris, 75014, France

NOT YET RECRUITING

Local Institution - 0085

Saint-Herblain, 44800, France

NOT YET RECRUITING

Local Institution - 0019

Paris, Île-de-France Region, 75005, France

NOT YET RECRUITING

Robert Bosch Krankenhaus

Stuttgart, Baden-Wurttemberg, 70376, Germany

RECRUITING

Local Institution - 0156

Marburg, Hesse, 35043, Germany

NOT YET RECRUITING

Local Institution - 0152

Homburg, Saarland, 66424, Germany

NOT YET RECRUITING

Local Institution - 0065

Cologne, 51109, Germany

NOT YET RECRUITING

Christliches Klinikum Halle (Saale) GmbH

Haile, 06120, Germany

RECRUITING

Local Institution - 0125

Hessen, 60590, Germany

NOT YET RECRUITING

Local Institution - 0128

Misterbianco, Catania, 95045, Italy

NOT YET RECRUITING

Local Institution - 0043

Bari, 70124, Italy

NOT YET RECRUITING

Local Institution - 0148

Bergamo, 24128, Italy

NOT YET RECRUITING

Local Institution - 0159

Milan, 20142, Italy

NOT YET RECRUITING

Local Institution - 0014

Ravenna, 48121, Italy

NOT YET RECRUITING

Local Institution - 0011

Rozzano (MI), 20089, Italy

NOT YET RECRUITING

Local Institution - 0114

Florești, Cluj, 407280, Romania

NOT YET RECRUITING

Local Institution - 0113

Timișoara, Timiș County, 300239, Romania

NOT YET RECRUITING

Local Institution - 0076

Bucharest, 022328, Romania

NOT YET RECRUITING

Institutul Oncologic Cluj

Cluj-Napoca, 400015, Romania

RECRUITING

Centrul de Oncologie Sf. Nectarie SRL

Craiova, 200347, Romania

RECRUITING

Victoria Hospital (Centrul de oncologie Euroclinic SRL) (Centrul De Oncologie Medicala) (Euroclinic Onchology Center)

Iași, 700106, Romania

RECRUITING

Institutul Regional de Oncologie Iasi

Iași, 700483, Romania

RECRUITING

Local Institution - 0132

Badalona, Barcelona, 8916, Spain

NOT YET RECRUITING

Local Institution - 0162

Seville, Seville, 41013, Spain

NOT YET RECRUITING

Local Institution - 0027

Barcelona, 08035, Spain

NOT YET RECRUITING

Local Institution - 0068

Barcelona, 08041, Spain

NOT YET RECRUITING

Local Institution - 0163

Barcelona, 8036, Spain

NOT YET RECRUITING

Local Institution - 0041

Madrid, 28041, Spain

WITHDRAWN

Local Institution - 0010

Majadahonda, 28222, Spain

NOT YET RECRUITING

Hospital Carlos Haya De Malaga

Málaga, 29010, Spain

RECRUITING

Local Institution - 0182

Birmingham, BIR, B9 5SS, United Kingdom

NOT YET RECRUITING

Local Institution - 0035

London, Greater London, SE19RT, United Kingdom

NOT YET RECRUITING

The Royal Surrey County Hospital NHS Foundation Trust

Guildford, GU2 7XX, United Kingdom

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Cisplatin; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): September 15, 2028
• Study Completion (Estimated): September 15, 2030
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

RO (7); DE (6); BR (4); AR (3); AU (5); CN (8); ES (8); CL (3); GB (3); FR (8); IT (6); US (12)