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

• Status: Not yet recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Collaborator: Shanghai Chest Hospital
• Treatments: Antibodies; Apatinib; Carboplatin; Pemetrexed

Criteria

Inclusion Criteria:

1. Subjects with histopathological diagnosis of adenocarcinoma non-small cell lung cancer (NSCLC) and clinical stage IV

2. has not received prior systemic treatment for metastatic NSCLC.

3. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status

4. confirmes by the central laboratory as KRAS gene mutation

5. Has archived Tumor tissue samples

6. Subject must have a measurable target lesion based on RECIST v1.1 .

7. 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.

8. Subjects should be voluntarily participate in clinical studies and informed consent should be signed.

Exclusion Criteria:

1. active brain metastases and meningeal metastasis

2. uncontrollable tumor-related pain

3. massive pleural effusion, peritoneal effusion or pericardial effusion which cannot be controlled by repeated drainage;

4. radiotherapy to lung that is >30 Gy within 24 weeks before the first dose,

5. imaging (CT or MRI) showed that the tumor invading the large vessels

6. Known EGFR/ALK mutation.

7. subjects with any known or suspected autoimmune diseases

8. subjects with known or suspected interstitial pneumonia;

9. Subjects with severe cardiovascular and cerebrovascular diseases

10. arteriovenous thrombosis events, such as deep vein thrombosis and pulmonary embolism, occurred within 3 months;

11. female subjects who are pregnant or lactation or who plan to be pregnant during the study period;

12. positive HIV test;

13. active hepatitis B

14. evidence of active TB infection within 1 year before first dose;

15. severe infection occurred within 4 weeks before the first dose

16. patients with clinically significant bleeding symptoms or with obvious bleeding tendency in the first month

17. subjects who is on systemic immunogenic agents;

18. a history of severe allergic reactions to other monoclonal antibodies/fusion proteins;

19. History of severe allergic reactions to carboplatin or pemetrexed or their preventive drugs;