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

Jiangsu HengRui Medicine Co., Ltd.0 sites106 target enrollmentMay 31, 2021

ConditionsLung Cancer

InterventionsSHR-1701； Famitinib SHR-1701

DrugsSHR-1701； Famitinib SHR-1701

Overview

Phase: Phase 2
Intervention: SHR-1701； Famitinib
Conditions: Lung Cancer
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 106
Primary Endpoint: Objective response rate (ORR) based on RECIST 1.1 criteria
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

May 31, 2021

End Date

December 31, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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
•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.

Arms & Interventions

SHR-1701+ Famitinib

Intervention: SHR-1701； Famitinib

SHR-1701

Intervention: SHR-1701

Outcomes

Primary Outcomes

Objective response rate (ORR) based on RECIST 1.1 criteria

Time Frame: up to approximately 1 year.

Secondary Outcomes

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.)