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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0170
Athens, Georgia, United States
NOT_YET_RECRUITINGLocal Institution - 0034
Lexington, Kentucky, United States
NOT_YET_RECRUITINGLocal Institution - 0171
Lexington, Kentucky, United States
NOT_YET_RECRUITINGLocal Institution - 0123
Baltimore, Maryland, United States
NOT_YET_RECRUITINGObjective response rate (ORR) by investigator (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1)
Time frame: Up to approximately 4 years
Number of participants with adverse events (AEs)
Time frame: Up to 90 days after discontinuation of study treatment
Number of participants with serious adverse events (SAEs)
Time frame: Up to 90 days after discontinuation of study treatment
Number of participants with treatment-related AEs
Time frame: Up to 90 days after discontinuation of study treatment
Number of participants with treatment-related SAEs
Time frame: Up to 90 days after discontinuation of study treatment
Number of participants with AEs leading to discontinuation
Time frame: Up to 90 days after discontinuation of study treatment
Number of deaths
Time frame: Up to 90 days after discontinuation of study treatment
Progression free survival (PFS) by investigator (per RECIST v1.1)
Time frame: Up to approximately 4 years
Overall survival (OS)
Time frame: Up to approximately 4 years
Duration of response (DOR) by investigator (per RECIST v1.1)
Time frame: Up to approximately 4 years
Time to recurrence (TTR) by investigator (per RECIST v1.1)
Time frame: Up to approximately 4 years
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Local Institution - 0180
Hattiesburg, Mississippi, United States
NOT_YET_RECRUITINGNebraska Cancer Specialists
Grand Island, Nebraska, United States
RECRUITINGOncology Hematology West PC
Omaha, Nebraska, United States
RECRUITINGLocal Institution - 0080
New York, New York, United States
NOT_YET_RECRUITINGLocal Institution - 0095
Houston, Texas, United States
NOT_YET_RECRUITINGLocal Institution - 0135
Madison, Wisconsin, United States
NOT_YET_RECRUITING...and 61 more locations