Status:
WITHDRAWN
A Trial of SHR-1701 With or Without Famitinib in Patients With Advanced or Metastatic NSCLC
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Non-Small-Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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
- voluntarily participate in the study and sign the informed consent form;
- 18 to 75 years old, both male and female;
- histologically or cytologically confirmed stage IIIB-IV or recurrent NSCLC
- one prior platinum-containing chemotherapy for advanced or metastatic disease;
- measurable lesions by RECIST v1.1;
- ECOG score: 0-1;
- life expectancy ≥ 3 months;
- adequate hematological, hepatic and renal function;
- non-surgically sterile female subjects of childbearing age must have a negative serum HCG test.
Exclusion
- histologically or cytologically confirmed mixed SCLC and NSCLC;
- known sensitising EGFR mutation and/or ALK translocation in patients with non-squamous NSCLC;
- tumor infiltration into the great vessels on imaging;
- active CNS metastases;
- malignancies other than NSCLC within 5 years;
- anticancer therapy within 4 weeks before the start of trial treatment;
- persisting toxicity related to prior therapy of Grade \> 1;
- treatment with systemic immunostimulatory agents within 4 weeks;
- treatment with systemic immunosuppressive agents within 2 weeks;
- autoimmune diseases;
- interstitial lung disease or other lung diseases that is symptomatic or may interfere the management of suspected drug-related pulmonary toxicity;
- clinically significant cardiovascular or cerebrovascular diseases;
- inadequately controlled hypertension;
- history of hemoptysis (≥ 2.5mL of bright red blood per episode) within 1 month;
- venous or arterial thrombosis within 6 months;
- evidence of bleeding diathesis or coagulopathy;
- use of anticoagulants or thrombolytic agents that has not been stable;
- active Tuberculosis infection;
- significant acute or chronic infections within 1 month;
- known history of testing positive test for HIV or known AIDS;
- hepatitis B virus or hepatitis C virus infection;
- allergic to any component of the treatment regimen;
- other conditions that in the opinion of the investigator would make participation in this clinical trial inappropriate.
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04699968
Start Date
January 15 2021
End Date
November 15 2021
Last Update
June 7 2023
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