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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
View on ClinicalTrials.gov →
NCT07680764
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
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Actively Recruiting
PhasePhase 2
SponsorBristol-Myers Squibb
Started2026-08-15
Est. completion2028-09-15
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations11 sites
View on ClinicalTrials.gov →
NCT07680764