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NCT Number: NCT07680764

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)

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)

Recruiting

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Key information

Conditions

Locally Advanced Non-Small Cell Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Metastatic Non-Small Cell Lung Cancer (NSCLC) Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution - 0092, Viedma, Río Negro Province, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pumitamig

Drug

Specified dose on specified days

Other names: BMS-986545, BNT327, PM8002

Imzokitug

Drug

Specified dose on specified days

Other names: Anti-CCR8, BMS-986340

Primary outcomes

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

    Time frame: Up to approximately 4 years

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 90 days after discontinuation of study treatment

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to 90 days after discontinuation of study treatment

  3. Number of participants with treatment-related AEs

    Time frame: Up to 90 days after discontinuation of study treatment

  4. Number of participants with treatment-related SAEs

    Time frame: Up to 90 days after discontinuation of study treatment

  5. Number of participants with AEs leading to discontinuation

    Time frame: Up to 90 days after discontinuation of study treatment

  6. Number of deaths

    Time frame: Up to 90 days after discontinuation of study treatment

  7. Progression free survival (PFS) by investigator (per RECIST v1.1)

    Time frame: Up to approximately 4 years

  8. Overall survival (OS)

    Time frame: Up to approximately 4 years

  9. Duration of response (DOR) by investigator (per RECIST v1.1)

    Time frame: Up to approximately 4 years

  10. Time to recurrence (TTR) by investigator (per RECIST v1.1)

    Time frame: Up to approximately 4 years

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Jul 2, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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