Status:
TERMINATED
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
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsors:
Shanghai Chest Hospital
Conditions:
NSCLC Stage IV
KRAS Gene Mutation
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 sta...
Eligibility Criteria
Inclusion
- Subjects with histopathological diagnosis of adenocarcinoma non-small cell lung cancer (NSCLC) and clinical stage IV
- has not received prior systemic treatment for metastatic NSCLC.
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status
- confirmes by the central laboratory as KRAS gene mutation
- Has archived Tumor tissue samples
- Subject must have a measurable target lesion based on RECIST v1.1 .
- Women of childbearing age must undergo a serological pregnancy test within 3 days before the first dose with negative results. Female subjects of reproductive age and male subjects whose spouse is a woman of reproductive age must agree to effective contraception within 180 days after the study period and the last dose of the study drug.
- Subjects should be voluntarily participate in clinical studies and informed consent should be signed.
Exclusion
- active brain metastases and meningeal metastasis
- uncontrollable tumor-related pain
- massive pleural effusion, peritoneal effusion or pericardial effusion which cannot be controlled by repeated drainage;
- radiotherapy to lung that is \>30 Gy within 24 weeks before the first dose,
- imaging (CT or MRI) showed that the tumor invading the large vessels
- Known EGFR/ALK mutation.
- subjects with any known or suspected autoimmune diseases
- subjects with known or suspected interstitial pneumonia;
- Subjects with severe cardiovascular and cerebrovascular diseases
- arteriovenous thrombosis events, such as deep vein thrombosis and pulmonary embolism, occurred within 3 months;
- female subjects who are pregnant or lactation or who plan to be pregnant during the study period;
- positive HIV test;
- active hepatitis B
- evidence of active TB infection within 1 year before first dose;
- severe infection occurred within 4 weeks before the first dose
- patients with clinically significant bleeding symptoms or with obvious bleeding tendency in the first month
- subjects who is on systemic immunogenic agents;
- a history of severe allergic reactions to other monoclonal antibodies/fusion proteins;
- History of severe allergic reactions to carboplatin or pemetrexed or their preventive drugs;
Key Trial Info
Start Date :
July 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03777124
Start Date
July 11 2019
End Date
June 29 2023
Last Update
July 4 2025
Active Locations (1)
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1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200120