RecruitingPhase 3NCT06416410

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

Sponsor

Allist Pharmaceuticals, Inc.

Enrollment

392 participants

Start Date

Aug 7, 2024

Study Type

INTERVENTIONAL

Conditions

Advanced Non-squamous Non-small-cell Lung Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two new targeted drugs — JAB-21822 and JAB-3312 — against standard chemotherapy as the first treatment for advanced non-small cell lung cancer (NSCLC) that has a specific genetic change called KRAS G12C mutation. This mutation is a known cancer driver that was historically very hard to target. **You may be eligible if...** - You are 18 or older - You have advanced or metastatic lung cancer (non-squamous NSCLC) confirmed by biopsy - Your tumor has the KRAS G12C mutation, confirmed by a central lab test - You have not received any prior treatment for your advanced or metastatic lung cancer - You have at least one measurable tumor on scans - Your general health is good (ECOG 0 or 1) - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have had another cancer in the past 2 years - Your tumor has a different genetic mutation with an available targeted drug - You have untreated brain metastases (cancer spread to the brain) - You have uncontrolled fluid around your lungs or heart - You have significant heart problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJAB-21822

JAB-21822 administered orally as a tablet

DRUGTislelizumab

Tislelizumab administered as an intravenous (IV) infusion

DRUGJAB-3312

JAB-3312 administered orally as a tablet or capsule

DRUGPemetrexed

Pemetrexed administered as an intravenous (IV) infusion

DRUGCarboplatin

Carboplatin administered as an intravenous (IV) infusion