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

Study Overview
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Brief Summary
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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

Official Title
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Phase II Clinical Trial of SHR-1701 With or Without Famitinib in the Treatment of Advanced or Metastatic NSCLC

Conditions
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Non-Small-Cell Lung Cancer

Intervention / Treatment
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* Drug: SHR-1701，Famitinib
* Drug: SHR-1701


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: SHR-1701 with or without Famitinib
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A<br> | Drug: SHR-1701，Famitinib<br>* SHR -1701, Intravenous ；Famitinib, oral<br>|
| Experimental: Treatment group B<br> | Drug: SHR-1701<br>* SHR -1701, Intravenous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective Response Rate | determined by RECIST v1.1, up to approximately 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression-Free-Survival | determined by RECIST v1.1, up to approximately 1 year | 
| DCR | Disease Control Rate | determined by RECIST v1.1, up to approximately 1 year | 
| DoR | Duration of Response | determined by RECIST v1.1, up to approximately 1 year | 
| OS | Overall Survival | up to approximately 1 year | 
| AEs+ SAEs | Adverse Events and Serious Adverse Events | determined by NCI-CTCAE V5.0, from the first drug administration to within 90 days for the last SHR-1701 dose |