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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
416
Participants receive Sosimerasib in combination with IN10018 orally once daily (QD) in a 21-day cycle, until disease progression or unacceptable toxicity
Participants 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.
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
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).
Time frame: 30 months
Objective Response Rate (ORR)
Defined as complete response (PR) + partial response (PR) assessed per RECIST v1.1 by BICR
Time frame: 30 months
Overall Survival (OS)
Defined as time from randomization to death by any cause
Time frame: up to 60 months
Disease Control Rate (DCR)
Defined as ORR + stable disease (SD) assessed per RECIST v1.1 by BICR
Time frame: 30 months
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
Time frame: 30 months
PFS by investigator assessment
Defined as time from randomization until disease progression or death from any cause, whichever occurs first assessed per RECIST v1.1 by investigator assessment.
Time frame: up to 30 months
Number of participants with adverse event
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Time frame: 30 months
Patient-reported outcome (PRO) questionnaire including EORTC QLQ-C30
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Reports of health status directly from participants
Time frame: up to 30 months
Patient-reported outcome (PRO) questionnaire including EORTC QLQ-LC13.
Reports of health status directly from participants
Time frame: up to 30 months