A Trial of SHR-1701 in Combination With and Without Famitinib Malate in Patients With Extensive Stage Small Cell Lung Cancer

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 in combination with or without famitinib malate for the treatment of extensive stage small cell lung cancer after the failure of previous systemic chemotherapy

Official Title
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An Open-label, Multicenter PhaseⅡ Study of SHR-1701 in Combination With or Without Famitinib Malate for the Treatment of Extensive Stage Small Cell Lung Cancer After Previous Systemic Chemotherapy Failure

Conditions
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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: Patients voluntarily participated in the clinical study, understood the study procedures and are able to sign the informed consent form. 18 to 75 years old, male or female. Histologically or cytologically confirmed extensive stage small cell lung cancer（ED-SCLC）. ECOG Performance Status of 0 or 1. Adequate hematological, hepatic and renal function. Female subjects of child-bearing potential must have a negative serum HCG test before treatment. Exclusion Criteria: Histologically or cytologically confirmed mixed SCLC and NSCLC. Untreated central nervous system metastases. Cancerous meningitis (meningeal metastasis). Uncontrolled pleural effusion, pericardial effusion or ascites. Tumor infiltration into the great vessels on imaging; Hemoptysis symptoms and maximum daily hemoptysis ≥ 2.5ml occurred within 1 month. Uncontrolled tumor-related pain. Malignancies other than SCLC within 5 years. Systemic antitumor therapy was received 4 weeks prior to trial treatment. History of autoimmune diseases. Significant cardiovascular disease. Inadequately controlled hypertension. Known history of testing positive test for HIV or known AIDS. Patients with active hepatitis B or hepatitis C Severe infections within 4 weeks prior to trial treatment. Active tuberculosis.

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 in combination with or without famitinib
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR-1701+ Famitinib<br> | Drug: SHR-1701； Famitinib<br>* SHR-1701+ Famitinib<br>|
| Experimental: SHR-1701<br> | Drug: SHR-1701<br>* SHR-1701<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) based on RECIST 1.1 criteria |  | up to approximately 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) based on RECIST 1.1 criteria |  | up to approximately 1 year. | 
| Disease control rate (DCR) based on RECIST 1.1 criteria |  | up to approximately 1 year. | 
| Duration of response (DoR) |  | up to approximately 1 year | 
| Overall survival (OS) |  | up to approximately 1 year | 
| AEs+ SAEs determined by NCI-CTCAE V5.0 |  | Baseline until up to 90 days after end of treatment. |