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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)
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)
Who can join
Ages 18 and older · All sexes
Full eligibility 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.
About the study
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)
What is being tested
- Pumitamig (drug)
- Imzokitug (drug)
- Pemetrexed (drug)
- Cisplatin (drug)
- Carboplatin (drug)
- Paclitaxel (drug)
Sponsor: Bristol-Myers Squibb · Participants: 160 · Started: Aug 31, 2026
Contact the study team
- BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · Phone: 855-907-3286
Official record on ClinicalTrials.gov — NCT07680764
Locations in the U.S.
| Georgia | Local Institution - 0170, Athens (Not yet recruiting) |
| Kentucky | Local Institution - 0034, Lexington (Not yet recruiting) Local Institution - 0171, Lexington (Not yet recruiting) |
| Maryland | Local Institution - 0123, Baltimore (Not yet recruiting) |
| Mississippi | Local Institution - 0180, Hattiesburg (Not yet recruiting) |
| Nebraska | Nebraska Cancer Specialists, Grand Island Oncology Hematology West PC, Omaha |
| New York | Local Institution - 0080, New York (Not yet recruiting) |
| Texas | Local Institution - 0095, Houston (Not yet recruiting) |
| Wisconsin | Local Institution - 0135, Madison (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.