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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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-03-03

No results posted yet for this study

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).

Conditions

Interventions

DRUG

IN10018 in combination with D-1553

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

DRUG

anti-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

Sponsors & Collaborators

  • InxMed (Shanghai) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhengbo Song Professor, Doctor · Zhejiang Cancer Hospital

  • Shun Lu Professor, Doctor · Shanghai Chest Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-10
Primary Completion
2028-09-30
Completion
2030-09-30
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07174908 on ClinicalTrials.gov