NCT06416410 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
| NCT ID | NCT06416410 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Allist Pharmaceuticals, Inc. |
| Condition | Advanced Non-squamous Non-small-cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 392 participants |
| Start Date | 2024-08-07 |
| Primary Completion | 2026-09-30 |
Trial Parameters
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Brief 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 Criteria
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
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