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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
Sponsor: InxMed (Shanghai) Co., Ltd.
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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2025-09-10
Completion Date
2030-09
Last Updated
2026-03-03
Healthy Volunteers
No
Conditions
Interventions
IN10018 in combination with D-1553
IN10018 100mg QD PO and D-1553 600mg BID PO, 21days per cycle
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
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