Back to resultsSintilimab Combined With Docetaxel for Standard Chemotherapy Failure Non-driver Gene Mutation Metastatic Non-small Cell Lung Cancer
Primary Purpose
Non-small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sintilimab Combined With Docetaxel Monotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Life expectancy exceeds 3 months
- The investigator confirmed at least one measurable lesion according to the RECIST 1.1 standard.
Exclusion Criteria:
- small cell lung cancer or small cell lung cancer
- Currently involved in interventional clinical research or treatment, or have received other research drugs or used research equipment within 4 weeks prior to the first dose;
- Previously received the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors (eg, CTLA-4, OX-40, CD137);
Sites / Locations
- Hunan Provincal Tumor Hospital
- Yongchang Z MD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sintilimab Combined With Docetaxel
Arm Description
Sintilimab Combined With Docetaxel for Metastatic or Non-driver Gene Mutation Non-small Cell Lung Cancer
Outcomes
Primary Outcome Measures
ORR
To measure the patients's overall response rate
Secondary Outcome Measures
PFS
Progression free survival
OS
Overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04144582
Brief Title
Sintilimab Combined With Docetaxel for Standard Chemotherapy Failure Non-driver Gene Mutation Metastatic Non-small Cell Lung Cancer
Official Title
Multiple-center, Single-arm, Phase II Study on Sintilimab Combined With Docetaxel in Non-driver Gene Mutation Advanced NSCLC Patients Who Had Failed With Double Platinum-based Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yongchang Zhang
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 purpose of this study is to assess the safety and effectiveness of Sintilimab Combined With Docetaxel in Non-driver Gene Mutation NSCLC patients who failed with double platinum-based chemotherapy
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
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sintilimab Combined With Docetaxel
Arm Type
Experimental
Arm Description
Sintilimab Combined With Docetaxel for Metastatic or Non-driver Gene Mutation Non-small Cell Lung Cancer
Intervention Type
Drug
Intervention Name(s)
Sintilimab Combined With Docetaxel Monotherapy
Intervention Description
Sintilimab 200mg i.v q3w , Docetaxel 75mg/m2 i.v q3w
Primary Outcome Measure Information:
Title
ORR
Description
To measure the patients's overall response rate
Time Frame
Approximately 1 years
Secondary Outcome Measure Information:
Title
PFS
Description
Progression free survival
Time Frame
Approximately 1 years
Title
OS
Description
Overall survival
Time Frame
Approximately 1 years
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:
Life expectancy exceeds 3 months
The investigator confirmed at least one measurable lesion according to the RECIST 1.1 standard.
Exclusion Criteria:
small cell lung cancer or small cell lung cancer
Currently involved in interventional clinical research or treatment, or have received other research drugs or used research equipment within 4 weeks prior to the first dose;
Previously received the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors (eg, CTLA-4, OX-40, CD137);
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongchang Z MD, MD
Organizational Affiliation
Hunan Province Tumor Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunan Provincal Tumor Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Yongchang Z MD
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
12. IPD Sharing Statement
Learn more about this trial
Sintilimab Combined With Docetaxel for Standard Chemotherapy Failure Non-driver Gene Mutation Metastatic Non-small Cell Lung Cancer
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