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NOT YET RECRUITING
NCT07833202
PHASE3

A Phase 3 Study of Sosimerasib in Combination With IN10018 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation

Sponsor: Shanghai Jeyou Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a randomized, positive controlled, open-Label and multicenter phase III study, to evaluate the efficacy and safety of Sosimerasib in combination with IN10018 versus anti-PD-1 monoclonal antibody in combination with carboplatin and pemetrexed as the first-line treatment for the locally advanced or metastatic non-squamous non-small cell lung cancer with KRAS G12C mutation.

Official title: A Phase 3, Randomized, Positive Controlled, Open-Label and Multicenter Study of Sosimerasib in Combination With IN10018 Versus Standard Therapy for the Treatment of First Line Locally-advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

416

Start Date

2026-10

Completion Date

2030-09

Last Updated

2026-09-24

Healthy Volunteers

No

Conditions

Interventions

DRUG

Sosimerasib in combination with IN10018

Participants receive Sosimerasib in combination with IN10018 orally once daily (QD) in a 21-day cycle, until disease progression or unacceptable toxicity

DRUG

Tislelizumab + Carboplatin + Pemetrexed

Participants receive Tislelizumab Q3W IV until disease progression or up to 2 years, plus Carboplatin Q3W IV for up to 4 cycles, plus Pemetrexed Q3W IV until disease progression.

Locations (1)

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China