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

Phase 2

• Conditions: Lung Cancer
• Interventions: Drug: SHR-1701； Famitinib; Drug: SHR-1701

• Registration Number: NCT04884009
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-07
• Study First Submitted QC: 2021-05-07
• Last Update Submitted: 2021-05-07
• Study First Posted: 2021-05-12
• Last Update Posted: 2021-05-12
• Study Start: 2021-05-31
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

1. Patients voluntarily participated in the clinical study, understood the study procedures and are able to sign the informed consent form.
2. 18 to 75 years old, male or female.
3. Histologically or cytologically confirmed extensive stage small cell lung cancer（ED-SCLC）.
4. ECOG Performance Status of 0 or 1.
5. Adequate hematological, hepatic and renal function.
6. Female subjects of child-bearing potential must have a negative serum HCG test before treatment.

Exclusion Criteria

1. Histologically or cytologically confirmed mixed SCLC and NSCLC.
2. Untreated central nervous system metastases.
3. Cancerous meningitis (meningeal metastasis).
4. Uncontrolled pleural effusion, pericardial effusion or ascites.
5. Tumor infiltration into the great vessels on imaging;
6. Hemoptysis symptoms and maximum daily hemoptysis ≥ 2.5ml occurred within 1 month.
7. Uncontrolled tumor-related pain.
8. Malignancies other than SCLC within 5 years.
9. Systemic antitumor therapy was received 4 weeks prior to trial treatment.
10. History of autoimmune diseases.
11. Significant cardiovascular disease.
12. Inadequately controlled hypertension.
13. Known history of testing positive test for HIV or known AIDS.
14. Patients with active hepatitis B or hepatitis C
15. Severe infections within 4 weeks prior to trial treatment.
16. Active tuberculosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR-1701+ Famitinib	SHR-1701； Famitinib	-
SHR-1701	SHR-1701	-

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR) based on RECIST 1.1 criteria	up to approximately 1 year.

Secondary Outcome Measures

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