A Trial of SHR-1701 in Combination With and Without Famitinib Malate in Patients With Extensive Stage Small Cell Lung Cancer
Primary Purpose
Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SHR-1701; Famitinib
SHR-1701
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer
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 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SHR-1701+ Famitinib
SHR-1701
Arm Description
Outcomes
Primary Outcome Measures
Objective response rate (ORR) based on RECIST 1.1 criteria
Secondary Outcome Measures
Progression free survival (PFS) based on RECIST 1.1 criteria
Disease control rate (DCR) based on RECIST 1.1 criteria
Duration of response (DoR)
Overall survival (OS)
AEs+ SAEs determined by NCI-CTCAE V5.0
Full Information
NCT ID
NCT04884009
First Posted
May 7, 2021
Last Updated
May 7, 2021
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04884009
Brief Title
A Trial of SHR-1701 in Combination With and Without Famitinib Malate in Patients With Extensive Stage Small Cell Lung Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 31, 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
SHR-1701 in combination with or without famitinib
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SHR-1701+ Famitinib
Arm Type
Experimental
Arm Title
SHR-1701
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SHR-1701; Famitinib
Intervention Description
SHR-1701+ Famitinib
Intervention Type
Drug
Intervention Name(s)
SHR-1701
Intervention Description
SHR-1701
Primary Outcome Measure Information:
Title
Objective response rate (ORR) based on RECIST 1.1 criteria
Time Frame
up to approximately 1 year.
Secondary Outcome Measure Information:
Title
Progression free survival (PFS) based on RECIST 1.1 criteria
Time Frame
up to approximately 1 year.
Title
Disease control rate (DCR) based on RECIST 1.1 criteria
Time Frame
up to approximately 1 year.
Title
Duration of response (DoR)
Time Frame
up to approximately 1 year
Title
Overall survival (OS)
Time Frame
up to approximately 1 year
Title
AEs+ SAEs determined by NCI-CTCAE V5.0
Time Frame
Baseline until up to 90 days after end of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Shi
Phone
021-68868570
Email
wei.shi@hengrui.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huan Li
Phone
17721286513
Email
huan.li@hengrui.com
12. IPD Sharing Statement
Learn more about this trial
A Trial of SHR-1701 in Combination With and Without Famitinib Malate in Patients With Extensive Stage Small Cell Lung Cancer
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