Back to resultsStudy of Anlotinib Combined With Docetaxel in Non-Driver Mutation Non-squamous NSCLC: the Save Study (SAVE)
Primary Purpose
Non-Squamous Non Small Cell Lung Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anlotinib and Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Non-Squamous Non Small Cell Lung Cancer focused on measuring Anlotinib Combined With Docetaxel
Eligibility Criteria
Inclusion Criteria:
18，Pathologically proven Non squamous non small cell lung cancer
- No-drive gene mutaion (EGFR、ALK、ROS1） by NGS
- Progress after second line
- PS score 0-2
Exclusion Criteria:
- Patients received second line treatment
- Patients received treatment of Anlotinib or Docetaxel
- Patients with contraindication of chemotherapy
- Pregnant or breast feeding women
Sites / Locations
- Hunan Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cohorts
Arm Description
Phase II Study to evaluate the Effectiveness and Safety of Anlotinib combined with Docetaxel in Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer
Outcomes
Primary Outcome Measures
ORR
overall response rate
Secondary Outcome Measures
PFS
Progression survival time
OS
overall survival time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03646968
Brief Title
Study of Anlotinib Combined With Docetaxel in Non-Driver Mutation Non-squamous NSCLC: the Save Study
Acronym
SAVE
Official Title
Phase II Study to Evaluate the Effectiveness and Safety of Anlotinib Combined With Docetaxel in Progress After First Line Standard Cheomotherapy in Advanced Non-driver Mutation Non- Squamous Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the Effectiveness and Safety of Anlotinib combined with Docetaxel in Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer
Detailed Description
The purpose of this study is to evaluate the Effectiveness and Safety of Anlotinib combined with Docetaxel in Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer .According to the result of TAX317,the ORR of second line standard chemotherapy was 5- 8%. We expect the ORR was 20%. Using PASS11, we calculated the sample size of this study was 39 , according to 10% censoring,the expected sample size is 43.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Squamous Non Small Cell Lung Cancer
Keywords
Anlotinib Combined With Docetaxel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohorts
Arm Type
Experimental
Arm Description
Phase II Study to evaluate the Effectiveness and Safety of Anlotinib combined with Docetaxel in Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer
Intervention Type
Drug
Intervention Name(s)
Anlotinib and Docetaxel
Intervention Description
Patients who was Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer recieved the treatment of Anlotinib and Docetaxel (Anlotinib, 12mg, po,qd and Docetaxel 175mg/m2, ivgtt, every 21day)
Primary Outcome Measure Information:
Title
ORR
Description
overall response rate
Time Frame
may 2018- may 2019 (1 year)
Secondary Outcome Measure Information:
Title
PFS
Description
Progression survival time
Time Frame
may 2018- may 2019 (1 year)
Title
OS
Description
overall survival time
Time Frame
may 2018- may 2019 (1 year)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18，Pathologically proven Non squamous non small cell lung cancer
No-drive gene mutaion (EGFR、ALK、ROS1） by NGS
Progress after second line
PS score 0-2
Exclusion Criteria:
Patients received second line treatment
Patients received treatment of Anlotinib or Docetaxel
Patients with contraindication of chemotherapy
Pregnant or breast feeding women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongchang Zhang, MD
Phone
+8613873123436
Ext
7+861383123436
Email
yangnong0217@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yongchang Zhang, MD
Phone
+8613873123436
Ext
+8613873123436
Email
zhangyongchang@csu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongchang Zhang, MD
Organizational Affiliation
Hunan Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongchang Zhang, MD
Phone
+86 731 89762323
Email
zhangyongchang@csu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yongchang Zhang, MD
Phone
+86 731 89762321
Email
zhangyongchang@csu.edu.cn
First Name & Middle Initial & Last Name & Degree
Nong Yang, MD
12. IPD Sharing Statement
Learn more about this trial
Study of Anlotinib Combined With Docetaxel in Non-Driver Mutation Non-squamous NSCLC: the Save Study
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