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NCT07680764
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)
Conditions: Locally Advanced Non-Small Cell Lung Cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer (NSCLC)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 160
Sponsor: Bristol-Myers Squibb
Location: Local Institution - 0170 Athens Georgia
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 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.
Source: ClinicalTrials.gov (NCT07680764). StuddyBuddy aggregates publicly available trial information.