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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

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

Recruiting
18 years and older
All
Phase 3

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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

Study details
    Advanced Non-squamous Non-small-cell Lung Cancer
    Metastatic Non-squamous Non Small Cell Lung Cancer

NCT06416410

Allist Pharmaceuticals, Inc.

15 October 2025

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