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

Hengrui Medicine

Status and phase: Withdrawn; Phase 2

Conditions: Non-Small-Cell Lung Cancer

Treatments: Drug: SHR-1701，Famitinib; Drug: SHR-1701

Study type: Interventional

Funder types: Industry

Identifiers

NCT04699968

SHR-1701-Ⅱ-206

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Treatment group A

Experimental group

Treatment:

Drug: SHR-1701，Famitinib

Treatment group B

Experimental group

Treatment:

Drug: SHR-1701