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)

June 26, 2026 updated by: Bristol-Myers Squibb

A Phase 2, Randomized, Open-label, Study Assessing 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)

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ANZ
        • Local Institution - 0094
        • Contact:
          • Site 0094
    • Río Negro Province
      • Viedma, Río Negro Province, Argentina, R8500ACE
        • Local Institution - 0092
        • Contact:
          • Site 0092
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Local Institution - 0082
        • Contact:
          • Site 0082
  • Australia
    • New South Wales
      • Gosford, New South Wales, Australia, 2250
        • Local Institution - 0074
        • Contact:
          • Site 0074
      • Westmead, New South Wales, Australia, 2145
        • Local Institution - 0134
        • Contact:
          • Site 0134
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Local Institution - 0167
        • Contact:
          • Site 0167
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution - 0100
        • Contact:
          • Site 0100
    • Western Australia
      • Perth, Western Australia, Australia, 6150
        • Local Institution - 0048
        • Contact:
          • Site 0048
  • Brazil
      • São Paulo, Brazil, 01246-000
        • Local Institution - 0001
        • Contact:
          • Site 0001
    • Rio Grande do Norte
      • Natal/RN, Rio Grande do Norte, Brazil, 59062-000
        • Local Institution - 0003
        • Contact:
          • Site 0003
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 91610-000
        • Local Institution - 0006
        • Contact:
          • Site 0006
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784
        • Local Institution - 0005
        • Contact:
          • Site 0005
  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7500713
        • Local Institution - 0081
        • Contact:
          • Site 0081
      • Santiago, Santiago Metropolitan, Chile, 8420383
        • Local Institution - 0149
        • Contact:
          • Site 0149
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520598
        • Local Institution - 0084
        • Contact:
          • Site 0084
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Local Institution - 0038
        • Contact:
          • Site 0038
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Local Institution - 0138
        • Contact:
          • Site 0138
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Local Institution - 0050
        • Contact:
          • Site 0050
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Local Institution - 0147
        • Contact:
          • Site 0147
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200030
        • Local Institution - 0140
        • Contact:
          • Site 0140
      • Shanghai, Shanghai Municipality, China, 200032
        • Local Institution - 0169
        • Contact:
          • Site 0169
    • Sichuan
      • Chengdu, Sichuan, China, 610213
        • Local Institution - 0144
        • Contact:
          • Site 0144
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Local Institution - 0168
        • Contact:
          • Site 0168
      • Hangzhou, Zhejiang, China, 310003
        • Local Institution - 0139
        • Contact:
          • Site 0139
      • Hangzhou, Zhejiang, China, 310016
        • Local Institution - 0137
        • Contact:
          • Site 0137
  • France
      • Grenoble, France, 38043 Cedex 09
        • Local Institution - 0047
        • Contact:
          • Site 0047
      • Paris, France, 75014
        • Local Institution - 0109
        • Contact:
          • Site 0109
      • Saint-Herblain, France, 44800
        • Local Institution - 0085
        • Contact:
          • Site 0085
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 6100
        • Local Institution - 0131
        • Contact:
          • Site 0131
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13385
        • Local Institution - 0110
        • Contact:
          • Site 0110
    • Languedoc-Roussillon
      • Montpellier, Languedoc-Roussillon, France, 34070
        • Local Institution - 0087
        • Contact:
          • Site 0087
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94800
        • Local Institution - 0119
        • Contact:
          • Site 0119
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75005
        • Local Institution - 0019
        • Contact:
          • Site 0019
  • Germany
      • Cologne, Germany, 51109
        • Local Institution - 0065
        • Contact:
          • Site 0065
      • Haile, Germany, 06120
        • Local Institution - 0042
        • Contact:
          • Site 0042
      • Hessen, Germany, 60590
        • Local Institution - 0125
        • Contact:
          • Site 0125
    • Baden-Wurttemberg
      • Stuttgart, Baden-Wurttemberg, Germany, 70376
        • Local Institution - 0126
        • Contact:
          • Site 0126
    • Hesse
      • Marburg, Hesse, Germany, 35043
        • Local Institution - 0156
        • Contact:
          • Site 0156
    • Saarland
      • Homburg, Saarland, Germany, 66424
        • Local Institution - 0152
        • Contact:
          • Site 0152
  • Italy
      • Bari, Italy, 70124
        • Local Institution - 0043
        • Contact:
          • Site 0043
      • Bergamo, Italy, 24128
        • Local Institution - 0148
        • Contact:
          • Site 0148
      • Milan, Italy, 20142
        • Local Institution - 0159
        • Contact:
          • Site 0159
      • Ravenna, Italy, 48121
        • Local Institution - 0014
        • Contact:
          • Site 0014
      • Rozzano (MI), Italy, 20089
        • Local Institution - 0011
        • Contact:
          • Site 0011
    • Catania
      • Misterbianco, Catania, Italy, 95045
        • Local Institution - 0128
        • Contact:
          • Site 0128
  • Romania
      • Bucharest, Romania,  022328
        • Local Institution - 0076
        • Contact:
          • Site 0076
      • Cluj-Napoca, Romania, 400015
        • Local Institution - 0008
        • Contact:
          • Site 0008
      • Craiova, Romania, 200347
        • Local Institution - 0075
        • Contact:
          • Site 0075
      • Iași, Romania, 700106
        • Local Institution - 0115
        • Contact:
          • Site 0115
      • Iași, Romania, 700483
        • Local Institution - 0116
        • Contact:
          • Site 0116
    • Cluj
      • Florești, Cluj, Romania, 407280
        • Local Institution - 0114
        • Contact:
          • Site 0114
    • Timiș County
      • Timișoara, Timiș County, Romania, 300239
        • Local Institution - 0113
        • Contact:
          • Site 0113
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution - 0027
        • Contact:
          • Site 0027
      • Barcelona, Spain, 08041
        • Local Institution - 0068
        • Contact:
          • Site 0068
      • Barcelona, Spain, 8036
        • Local Institution - 0163
        • Contact:
          • Site 0163
      • Madrid, Spain, 28041
        • Local Institution - 0041
        • Contact:
          • Site 0041
      • Majadahonda, Spain, 28222
        • Local Institution - 0010
        • Contact:
          • Site 0010
      • Málaga, Spain, 29010
        • Local Institution - 0020
        • Contact:
          • Site 0020
    • Barcelona
      • Badalona, Barcelona, Spain, 8916
        • Local Institution - 0132
        • Contact:
          • Site 0132
    • Seville
      • Seville, Seville, Spain, 41013
        • Local Institution - 0162
        • Contact:
          • Site 0162
  • United Kingdom
      • Guildford, United Kingdom, GU2 7XX
        • Local Institution - 0037
        • Contact:
          • Site 0037
    • Greater London
      • London, Greater London, United Kingdom, SE19RT
        • Local Institution - 0035
        • Contact:
          • Site 0035
  • United States
    • Georgia
      • Athens, Georgia, United States, 30607
        • Local Institution - 0170
        • Contact:
          • Site 0170
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Local Institution - 0034
        • Contact:
          • Site 0034
      • Lexington, Kentucky, United States, 40509
        • Local Institution - 0171
        • Contact:
          • Site 0171
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Local Institution - 0123
        • Contact:
          • Site 0123
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Local Institution - 0102
        • Contact:
          • Site 0102
    • New York
      • New York, New York, United States, 10021
        • Local Institution - 0080
        • Contact:
          • Site 0080
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Local Institution - 0105
        • Contact:
          • Site 0105
    • Texas
      • Houston, Texas, United States, 77030
        • Local Institution - 0095
        • Contact:
          • Site 0095
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Local Institution - 0135
        • Contact:
          • Site 0135

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Drug: Imzokitug
Specified dose on specified days
Other Names:
  • BMS-986340
  • Anti-CCR8
Experimental: Arm B
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Drug: Imzokitug
Specified dose on specified days
Other Names:
  • BMS-986340
  • Anti-CCR8
Experimental: Arm C
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Drug: Imzokitug
Specified dose on specified days
Other Names:
  • BMS-986340
  • Anti-CCR8
Experimental: Arm D
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR) by investigator (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1)
Time Frame: Up to approximately 4 years
Up to approximately 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Number of participants with adverse events (AEs)
Time Frame: Up to 90 days after discontinuation of study treatment
Up to 90 days after discontinuation of study treatment
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 90 days after discontinuation of study treatment
Up to 90 days after discontinuation of study treatment
Number of participants with treatment-related AEs
Time Frame: Up to 90 days after discontinuation of study treatment
Up to 90 days after discontinuation of study treatment
Number of participants with treatment-related SAEs
Time Frame: Up to 90 days after discontinuation of study treatment
Up to 90 days after discontinuation of study treatment
Number of participants with AEs leading to discontinuation
Time Frame: Up to 90 days after discontinuation of study treatment
Up to 90 days after discontinuation of study treatment
Number of deaths
Time Frame: Up to 90 days after discontinuation of study treatment
Up to 90 days after discontinuation of study treatment
Progression free survival (PFS) by investigator (per RECIST v1.1)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Duration of response (DOR) by investigator (per RECIST v1.1)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Time to recurrence (TTR) by investigator (per RECIST v1.1)
Time Frame: Up to approximately 4 years
Up to approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2026

Primary Completion (Estimated)

September 15, 2028

Study Completion (Estimated)

September 15, 2030

Study Registration Dates

First Submitted

June 26, 2026

First Submitted That Met QC Criteria

June 26, 2026

First Posted (Actual)

July 2, 2026

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

June 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA052-1000
  • 2026-525170-19 (Other Identifier: EU CT Number)
  • U1111-1333-5867 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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