Back to resultsApatinib Combined With Vinorelbine for Non-driver Gene Mutation Non-small Cell Lung Cancer
Primary Purpose
Advanced Non Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Apatinib Combined With Vinorelbine
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Non Small Cell Lung Cancer focused on measuring Apatinib plus Vinorelbine, NSCLC
Eligibility Criteria
Inclusion Criteria:
18，Pathologically proven non small cell lung cancer
- Adenocarcinoma，No-drive gene mutaion (EGFR、ALK、ROS1） by NGS
- Squamous cell carcinoma，no gene detection
- Progress after second line
- PS score >2
Exclusion Criteria:
- Patients received apatinib or Vinorelbine treatment before
- EGFR, ALK or ROS1 mutation
- Patients with contraindication of chemotherapy
- Pregnant or breast feeding women
Sites / Locations
- Hunan Provincal Tumor Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Apatinib Combined With Vinorelbine
Arm Description
Apatinib Combined With Vinorelbine Used for Driver Gene Mutation Negative Third-line and Third-line Post Progression Advanced 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
NCT03652857
Brief Title
Apatinib Combined With Vinorelbine for Non-driver Gene Mutation Non-small Cell Lung Cancer
Official Title
the Effectiveness and Safety Study on Apatinib Combined With Vinorelbine Used for Driver Gene Mutation Negative Third-line and Third-line Post Progression Advanced Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
December 31, 2019 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the safety and effectiveness of Apatinib Combined With Vinorelbine Used for Driver Gene Mutation Negative Third-line and Third-line Posterior Advanced Non-small Cell Lung Cancer
Detailed Description
This efficacy and safety research plan to explore the use of Apatinib combined with Vinorelbine to driven gene mutation negative three line and three line later non-small cell lung cancer.According to the result of TAX317,the investigators expect the effective rate is 20% and 80% of degree of assurance.Single arm bilateral experiment's sample size is calculated 27, according to 10% censoring,the expected sample size is 30.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Non Small Cell Lung Cancer
Keywords
Apatinib plus Vinorelbine, NSCLC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Apatinib Combined With Vinorelbine
Arm Type
Experimental
Arm Description
Apatinib Combined With Vinorelbine Used for Driver Gene Mutation Negative Third-line and Third-line Post Progression Advanced Non-small Cell Lung Cancer
Intervention Type
Drug
Intervention Name(s)
Apatinib Combined With Vinorelbine
Intervention Description
Vinorelbine 60mg/m2 d1qweek , Apatinib 500mg po Qd,evaluate every 2months
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
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18，Pathologically proven non small cell lung cancer
Adenocarcinoma，No-drive gene mutaion (EGFR、ALK、ROS1） by NGS
Squamous cell carcinoma，no gene detection
Progress after second line
PS score >2
Exclusion Criteria:
Patients received apatinib or Vinorelbine treatment before
EGFR, ALK or ROS1 mutation
Patients with contraindication of chemotherapy
Pregnant or breast feeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nong Yang, 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
12. IPD Sharing Statement
Citations:
PubMed Identifier
32191330
Citation
Zhang X, Xiong Y, Xia Q, Wu F, Liu L, Zhou Y, Zeng L, Zhou C, Xia C, Jiang W, Liao D, Xiao L, Liu L, Yang H, Guan R, Li K, Wang J, Lei G, Zhang Y, Yang N. Efficacy and Safety of Apatinib Plus Vinorelbine in Patients With Wild-Type Advanced Non-Small Cell Lung Cancer After Second-Line Treatment Failure: A Nonrandomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e201226. doi: 10.1001/jamanetworkopen.2020.1226.
Results Reference
derived
Learn more about this trial
Apatinib Combined With Vinorelbine for Non-driver Gene Mutation Non-small Cell Lung Cancer
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