A Trial of SHR-1701 With or Without Famitinib in Patients With Advanced or Metastatic NSCLC

• Status: Not yet recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

Summary

The study is being conducted to evaluate the efficacy and safety of SHR-1701 with or without famitinib in patients with advanced or metastatic NSCLC

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

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

1. voluntarily participate in the study and sign the informed consent form;

2. 18 to 75 years old, both male and female;

3. histologically or cytologically confirmed stage IIIB-IV or recurrent NSCLC

4. one prior platinum-containing chemotherapy for advanced or metastatic disease;

5. measurable lesions by RECIST v1.1;

6. ECOG score: 0-1;

7. life expectancy ≥ 3 months;

8. adequate hematological, hepatic and renal function;

9. non-surgically sterile female subjects of childbearing age must have a negative serum HCG test.

Exclusion Criteria:

1. histologically or cytologically confirmed mixed SCLC and NSCLC;

2. known sensitising EGFR mutation and/or ALK translocation in patients with non-squamous NSCLC;

3. tumor infiltration into the great vessels on imaging;

4. active CNS metastases;

5. malignancies other than NSCLC within 5 years;

6. anticancer therapy within 4 weeks before the start of trial treatment;

7. persisting toxicity related to prior therapy of Grade > 1;

8. treatment with systemic immunostimulatory agents within 4 weeks;

9. treatment with systemic immunosuppressive agents within 2 weeks;

10. autoimmune diseases;

11. interstitial lung disease or other lung diseases that is symptomatic or may interfere the management of suspected drug-related pulmonary toxicity;

12. clinically significant cardiovascular or cerebrovascular diseases;

13. inadequately controlled hypertension;

14. history of hemoptysis (≥ 2.5mL of bright red blood per episode) within 1 month;

15. venous or arterial thrombosis within 6 months;

16. evidence of bleeding diathesis or coagulopathy;

17. use of anticoagulants or thrombolytic agents that has not been stable;

18. active Tuberculosis infection;

19. significant acute or chronic infections within 1 month;

20. known history of testing positive test for HIV or known AIDS;

21. hepatitis B virus or hepatitis C virus infection;

22. allergic to any component of the treatment regimen;

23. other conditions that in the opinion of the investigator would make participation in this clinical trial inappropriate.