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 (BMS)

Status and phase: Begins enrollment this month; Phase 2

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

Treatments: Drug: Pumitamig; Drug: Imzokitug

Study type: Interventional

Funder types: Industry

Identifiers

NCT07680764

2026-525170-19 (Other Identifier)

CA052-1000

U1111-1333-5867 (Other Identifier)

Details and patient eligibility

About

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)

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 4 patient groups

Arm A

Experimental group

Treatment:

Drug: Imzokitug

Drug: Pumitamig

Arm B

Experimental group

Treatment:

Drug: Imzokitug

Drug: Pumitamig

Arm C

Experimental group

Treatment:

Drug: Imzokitug

Drug: Pumitamig

Arm D

Experimental group

Treatment:

Drug: Pumitamig