This is a randomized, positive controlled, open-Label and multicenter phase III study, to evaluate the efficacy and safety of Sosimerasib in combination with IN10018 versus anti-PD-1 monoclonal antibody in combination with carboplatin and pemetrexed as the first-line treatment for the locally advanced or metastatic non-squamous non-small cell lung cancer with KRAS G12C mutation.
Histologically or cytologically documented Stage IIIB or IIIC NSCLC disease not amenable for surgical resection or definitive chemoradiation or Stage IV Non-squamous NSCLC disease.
Has KRAS G12C mutation confirmed by central laboratory.
Measurable disease according to RECIST 1.1.
An Eastern Cooperative Group (ECOG) performance status of 0 or 1.
Has another known driver mutation with approved first-line targeted therapy.
Participants with carcinomatous meningitis or spinal cord compression; or with other evidence indicating that central nervous system (CNS) metastases or leptomeningeal metastases are not yet controlled.
Prior treatment with KRAS G12C inhibitors, FAK inhibitors, or pan-RAS inhibitors.
History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.
Parallel
Sosimerasib in combination with IN10018
DrugParticipants receive Sosimerasib in combination with IN10018 orally once daily (QD) in a 21-day cycle, until disease progression or unacceptable toxicity
Tislelizumab + Carboplatin + Pemetrexed
DrugParticipants receive Tislelizumab Q3W IV until disease progression or up to 2 years, plus Carboplatin Q3W IV for up to 4 cycles, plus Pemetrexed Q3W IV until disease progression.
Progression-Free Survival (PFS)
Defined as time from randomization until disease progression or death from any cause, whichever occurs first assessed per RECIST v1.1 by blinded independent central review (BICR).
Objective Response Rate (ORR)
Defined as complete response (PR) + partial response (PR) assessed per RECIST v1.1 by BICR
Overall Survival (OS)
Defined as time from randomization to death by any cause
Disease Control Rate (DCR)
Defined as ORR + stable disease (SD) assessed per RECIST v1.1 by BICR
Duration of Response (DoR)
Defined as time from first evidence of PR or CR to disease progression or death due to any cause, whichever occurs first, assessed per RECIST v1.1 by BICR
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