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
Allist Pharmaceuticals, Inc.
392 participants
Aug 7, 2024
INTERVENTIONAL
Conditions
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 Criteria7
- 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 Criteria5
- 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
Interventions
JAB-21822 administered orally as a tablet
Tislelizumab administered as an intravenous (IV) infusion
JAB-3312 administered orally as a tablet or capsule
Pemetrexed administered as an intravenous (IV) infusion
Carboplatin administered as an intravenous (IV) infusion
Locations(37)
View Full Details on ClinicalTrials.gov
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NCT06416410