RecruitingPhase 3NCT07174908

A Phase 3 Study of IN10018 in Combination With D-1553 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation

A Phase 3 Multicenter, Randomized, Controlled, and Open-Label Study of IN10018 in Combination With D-1553 Versus Standard Therapy for the Treatment of First Line Locally-advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation


Sponsor

InxMed (Shanghai) Co., Ltd.

Enrollment

400 participants

Start Date

Sep 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, randomized, open-label, phase III clinical study, to evaluate the efficacy and safety of IN10018 in combination with D-1553 as compared to anti-PD-1 monoclonal antibody (mAb) in combination with platinum and pemetrexed as the first-line treatment for the locally advanced or metastatic KRASG12C mutation-positive non-squamous non-small cell lung cancer (NSCLC).


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 study is testing a new two-drug combination — IN10018 plus D-1553 — as a first-line treatment for people with advanced non-small cell lung cancer (NSCLC) that carries a specific genetic change called KRAS G12C. The combination is being compared to standard chemotherapy. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with advanced or metastatic non-squamous NSCLC (stage IIIB/C or IV) - Your tumor has been confirmed to have the KRAS G12C mutation - You have not yet received any systemic treatment for advanced lung cancer - You have good overall health (ECOG performance status 0-1) and adequate organ function - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - You have already received chemotherapy or targeted therapy for advanced NSCLC - Your cancer does not have the KRAS G12C mutation - You have significant health conditions that could affect your ability to tolerate treatment 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

DRUGIN10018 in combination with D-1553

IN10018 100mg QD PO and D-1553 600mg BID PO, 21days per cycle

DRUGanti-PD-1 monoclonal antibody in combination with platinum and pemetrexed

Tislelizumab 200mg Q3W IV + Carboplatin AUC 5 mg/mL/min or Cisplatin 75mg/m² Q3W IV+ Pemetrexed 500mg/m² Q3W IV


Locations(11)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Union Hospital Tongji Medidcal College Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

First Affiliated Hospital of Gannan Medical University

Gannan, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07174908


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