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

Summary

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

Conditions4

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