Back to resultsA Trial of SHR-1701 With or Without Famitinib in Patients With Advanced or Metastatic NSCLC
Primary Purpose
Non-Small-Cell Lung Cancer
Status
Withdrawn
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 Non-Small-Cell Lung Cancer
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Treatment group A
Treatment group B
Arm Description
Outcomes
Primary Outcome Measures
ORR
Objective Response Rate
Secondary Outcome Measures
PFS
Progression-Free-Survival
DCR
Disease Control Rate
DoR
Duration of Response
OS
Overall Survival
AEs+ SAEs
Adverse Events and Serious Adverse Events
Full Information
NCT ID
NCT04699968
First Posted
January 5, 2021
Last Updated
June 5, 2023
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04699968
Brief Title
A Trial of SHR-1701 With or Without Famitinib in Patients With Advanced or Metastatic NSCLC
Official Title
Phase II Clinical Trial of SHR-1701 With or Without Famitinib in the Treatment of Advanced or Metastatic NSCLC
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor R & D Strategy Adjustment
Study Start Date
January 15, 2021 (Anticipated)
Primary Completion Date
November 15, 2021 (Anticipated)
Study Completion Date
November 15, 2021 (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 with or without famitinib in patients with advanced or metastatic NSCLC
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small-Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
SHR-1701 with or without Famitinib
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group A
Arm Type
Experimental
Arm Title
Treatment group B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SHR-1701，Famitinib
Intervention Description
SHR -1701, Intravenous ；Famitinib, oral
Intervention Type
Drug
Intervention Name(s)
SHR-1701
Intervention Description
SHR -1701, Intravenous
Primary Outcome Measure Information:
Title
ORR
Description
Objective Response Rate
Time Frame
determined by RECIST v1.1, up to approximately 1 year
Secondary Outcome Measure Information:
Title
PFS
Description
Progression-Free-Survival
Time Frame
determined by RECIST v1.1, up to approximately 1 year
Title
DCR
Description
Disease Control Rate
Time Frame
determined by RECIST v1.1, up to approximately 1 year
Title
DoR
Description
Duration of Response
Time Frame
determined by RECIST v1.1, up to approximately 1 year
Title
OS
Description
Overall Survival
Time Frame
up to approximately 1 year
Title
AEs+ SAEs
Description
Adverse Events and Serious Adverse Events
Time Frame
determined by NCI-CTCAE V5.0, from the first drug administration to within 90 days for the last SHR-1701 dose
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:
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.
12. IPD Sharing Statement
Learn more about this trial
A Trial of SHR-1701 With or Without Famitinib in Patients With Advanced or Metastatic NSCLC
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