This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus platinum-doublet chemotherapy in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
630
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 - 0347
Birmingham, Alabama, United States
NOT_YET_RECRUITINGLocal Institution - 0581
Fullerton, California, United States
NOT_YET_RECRUITINGLocal Institution - 0682
Loma Linda, California, United States
NOT_YET_RECRUITINGLocal Institution - 0202
Long Beach, California, United States
NOT_YET_RECRUITINGProgression Free Survival (PFS) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded Independent Central Review (BICR)
Time frame: Up to 7 years
Overall Survival (OS)
Time frame: Up to 7 years
Overall Response (OR) as Assessed per RECIST v1.1 by BICR
Time frame: Up to 7 years
Duration of Response (DOR) as Assessed per RECIST 1.1 by BICR
Time frame: Up to 7 years
PFS as Assessed per RECIST v1.1 by Investigator
Time frame: Up to 7 years
Number of Participants With Adverse Events (AEs)
Time frame: Up to 90 days from last dose
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to 90 days from last dose
Number of Participants With AEs Leading to Dose Interruption
Time frame: Up to 90 days from last dose
Number of Participants With AEs Leading to Dose Reduction
Time frame: Up to 90 days from last dose
Number of Participants With AEs Leading to Treatment Discontinuation
Time frame: Up to 90 days from last dose
Number of Deaths
Time frame: Up to 90 days from last dose
Time to Definitive Deterioration by Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ) Total Score
Time frame: Up to 7 years
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30) Scale/item Score
Time frame: Up to 90 days from last dose
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CONTACT
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Local Institution - 0623
Santa Barbara, California, United States
NOT_YET_RECRUITINGLocal Institution - 0442
Denver, Colorado, United States
NOT_YET_RECRUITINGLocal Institution - 0680
Ocala, Florida, United States
NOT_YET_RECRUITINGLocal Institution - 0679
Orange City, Florida, United States
NOT_YET_RECRUITINGLocal Institution - 0621
Palm Bay, Florida, United States
NOT_YET_RECRUITINGLocal Institution - 0377
Tamarac, Florida, United States
NOT_YET_RECRUITING...and 325 more locations