Phase II Study of SHR-1210(Anti-PD-1 Antibody) Combination With Apatinib Versus Pemetrexed and Carboplatin in Subjects With KRAS Mutant Stage IV Non-squamous Non-small Cell Lung Cancer
NCT03777124 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2025-07-04
Summary
This is a randomized, open-label, multi-center, phase II trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus Pemetrexed and Carboplatin in Subjects with KRAS mutant stage IV non-squamous Non-small Cell Lung Cancer
Conditions
- NSCLC Stage IV
- KRAS Gene Mutation
- PD-1 Antibody
- Chemotherapy Effect
Interventions
- DRUG
-
SHR-1210
Subjects receive SHR-1210 intravenous every 2 weeks
- DRUG
-
Apatinib
Subjects receive Apatinib orally every day
- DRUG
-
Pemetrexed
Subjects receive Pemetrexed intravenous every 3 weeks
- DRUG
-
subjects receive carboplatin intravenous every 3 weeks
Sponsors & Collaborators
-
Shanghai Chest Hospital
collaborator OTHER -
Jiangsu HengRui Medicine Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jianjun Zou, MD, PhD · Jiangsu HengRui Medicine Co., Ltd.
-
Shun Lu, MD, PhD · Jiaotong University,Shanghai chest Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-11
- Primary Completion
- 2023-06-29
- Completion
- 2023-06-29
Countries
- China
Study Locations
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