Non-Small-Cell Lung Cancer
Conditions
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
Interventions
DRUGSHR-1701，Famitinib
SHR -1701, Intravenous ；Famitinib, oral
DRUGSHR-1701
SHR -1701, Intravenous
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
SHR-1701 with or without Famitinib
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | determined by RECIST v1.1, up to approximately 1 year | Objective Response Rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | determined by RECIST v1.1, up to approximately 1 year | Progression-Free-Survival |
| DCR | determined by RECIST v1.1, up to approximately 1 year | Disease Control Rate |
| DoR | determined by RECIST v1.1, up to approximately 1 year | Duration of Response |
| OS | up to approximately 1 year | Overall Survival |
| AEs+ SAEs | determined by NCI-CTCAE V5.0, from the first drug administration to within 90 days for the last SHR-1701 dose | Adverse Events and Serious Adverse Events |
Outcome results
None listed