Overview
This Phase 3 study will evaluate the efficacy of JAB-21822+JAB-3312 versus tislelizumab (PD-1 Ab) combined with pemetrexed+carboplatin as the first line treatment in subjects with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).
Eligibility
Inclusion Criteria:
- A signed written informed consent is required before performing any study-related operations
- Age greater than or equal to 18 years old
- Histologically or cytologically confirmed locally advanced/metastatic, unresectable non-squamous NSCLC with KRAS p. G12C mutation confirmed by the central lab
- No history of systemic anticancer therapy to the local advanced/metastatic disease
- Expected survival period greater than or equal to 3 months
- Having at least one target lesion according to RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) ≤ 1
Exclusion Criteria:
- Previous (≤2 years) or current solid tumors or hematologic tumors of other pathological types
- Carry other driver gene mutations with available target therapy, or carry other KRAS mutations
- Subjects with untreated central nervous system (CNS) metastases were excluded;
- Uncontrolled pleural effusion, pericardial effusion, and ascites
- Subjects with impaired heart function or clinically significant heart disease