Clinical trial NCT04699968: A Trial of SHR-1701 With or Without Famitinib in Patients With Advanced or Metastatic NSCLC
Official title: Phase II Clinical Trial of SHR-1701 With or Without Famitinib in the Treatment of Advanced or Metastatic NSCLC
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Non-Small-Cell Lung Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-01-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SHR-1701 with or without Famitinib
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: ORR
timeFrame: determined by RECIST v1.1, up to approximately 1 year
Secondary outcomes:
measure: PFS
timeFrame: determined by RECIST v1.1, up to approximately 1 year
measure: DCR
timeFrame: determined by RECIST v1.1, up to approximately 1 year
measure: DoR
timeFrame: determined by RECIST v1.1, up to approximately 1 year
measure: OS
timeFrame: up to approximately 1 year
measure: AEs+ SAEs
timeFrame: determined by NCI-CTCAE V5.0, from the first drug administration to within 90 days for the last SHR-1701 dose
Other outcomes:
Locations:
Study officials:
References: