Recruiting

Phase 2

Imzokitug & Pumitamig & PDCTA 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)

Sponsor:

Bristol-Myers Squibb

Code:

NCT07680764

Conditions

Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

Metastatic Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pumitamig

Imzokitug

Pemetrexed

Cisplatin

Carboplatin

Study Details

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)

Study ID

NCT07680764

Start date

Sep 10, 2026

Status verified date

Sep, 2026

Completion date

Sep 15, 2030

Anticipated

Primary completion date

Sep 15, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: Pumitamig + Imzokitug + Histology-based PDCT

experimental: Arm B: Pumitamig + Imzokitug + Histology-based PDCT

experimental: Arm C: Pumitamig + Imzokitug + Histology-based PDCT

experimental: Arm D: Pumitamig + Histology-based PDCT

Interventions

Pumitamig