JAB-21822 Combined With JAB-3312 Compared SOC in the First Line for Treatment of Advanced Non-small Cell Lung Cancer With KRAS p.G12C Mutation

An Open-label, Randomized, Positive Control, Multicenter Phase III Clinical Study. Evaluating JAB-21822 Combined With JAB-3312 Compared Tislelizumab Combined With Pemetrexed + Carboplatin in the First Line for Treatment of Advanced Non-squamous Non-small Cell Lung Cancer With KRAS p.G12C Mutation

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).

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