OncRef

Clinical 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

Status:

RECRUITING

Phase:

Phase 3

Lead Sponsor:InxMed (Shanghai) Co., Ltd.
Information Provided By:InxMed (Shanghai) Co., Ltd.
Last Update Posted:2026-03-03

Study Overview

Brief 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).

Official Title

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

Conditions

Non-Small Cell Lung Cancer

Intervention / Treatment

  • Drug: IN10018 in combination with D-1553
  • Drug: anti-PD-1 monoclonal antibody in combination with platinum and pemetrexed

Other Study ID Numbers

  • IN10018-023

Start Date (Actual)

2025-09-10

Primary Completion Date (Estimated)

2028-09

Study Completion Date (Estimated)

2030-09

Enrollment (Estimated)

400

Study Type

Interventional

Phase

Phase 3