A Trial of SHR-1701 With or Without Famitinib in Patients With Advanced or Metastatic NSCLC
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment group A
|
Drug: SHR-1701，Famitinib
SHR -1701, Intravenous ；Famitinib, oral
|
| Experimental: Treatment group B
|
Drug: SHR-1701
SHR -1701, Intravenous
|
Outcome Measures
Primary Outcome Measures
- ORR [determined by RECIST v1.1, up to approximately 1 year]
Objective Response Rate
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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 Criteria:
-
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHR-1701-Ⅱ-206