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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)

RECRUITINGPhase 2Sponsored by Bristol-Myers Squibb
Actively Recruiting
PhasePhase 2
SponsorBristol-Myers Squibb
Started2026-08-15
Est. completion2028-09-15
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations11 sites

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions4

CancerLocally Advanced Non-Small Cell Lung Cancer (NSCLC)Lung CancerMetastatic Non-small Cell Lung Cancer (NSCLC)

Interventions2

Locations11 sites

Local Institution - 0170
Athens, Georgia, 30607
Site 0170
Local Institution - 0034
Lexington, Kentucky, 40503
Site 0034
Local Institution - 0171
Lexington, Kentucky, 40509
Site 0171
Local Institution - 0123
Site 0123
Local Institution - 0180
Hattiesburg, Mississippi, 39401
Site 0180

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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