This is a trial to evaluate the efficacy, safety, and tolerability of HS-10370 in combination with Platinum-based Doublet Chemotherapy With or Without Adebrelimab Versus Tislelizumab Plus Platinum-based Doublet Chemotherapy as first-line treatment in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
448
Administered orally.
Administered intravenously
Administered intravenously
Administered intravenously
Administered intravenously
Administered intravenously
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR)
Time frame: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
Time frame: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Overall Survival (OS)
OS
Time frame: Randomization to date of death from any cause. (Estimated as up to 3 years)
Overall Response Rate (ORR)
ORR per RECIST v1.1 by BICR and Investigator
Time frame: Randomization to disease progression or death. (Estimated as approximately 1 year)
Duration of Response (DOR)
DOR per RECIST v1.1 by BICR and Investigator
Time frame: Randomization to disease progression or death. (Estimated as approximately 1 year)
Number of Participants with a Treatment Emergent Adverse Event(s) (TEAE)
Number of Participants with a TEAE
Time frame: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
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