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

NCT ID: NCT04699968

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2021-11-15

Brief 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

Conditions

Non-Small-Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group A

Group Type: EXPERIMENTAL

SHR-1701，Famitinib

Intervention Type: DRUG

SHR -1701, Intravenous ；Famitinib, oral

Treatment group B

Group Type: EXPERIMENTAL

SHR-1701

Intervention Type: DRUG

SHR -1701, Intravenous

Interventions

SHR-1701，Famitinib

SHR -1701, Intravenous ；Famitinib, oral

Intervention Type: DRUG

SHR-1701

SHR -1701, Intravenous

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SHR-1701-Ⅱ-206

Identifier Type: -

Identifier Source: org_study_id