drugset / Trial / NCT07174908

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

NCT07174908

Phase 3 Recruiting 400 enrolled InxMed (Shanghai) Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2025-09-10
Primary completion
2028-09
Completion
2030-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule 5 unknown Intravenous
Comparator Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject D-1553 Unknown 600 mg Oral
Subject Ifebemtinib Small molecule 100 mg Oral
Comparator Pemetrexed Small molecule 500 mg/m2 Intravenous
Comparator Tislelizumab Monoclonal antibody 200 mg Intravenous