Apatinib Combined With Vinorelbine for Non-driver Gene Mutation Non-small Cell Lung Cancer
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
1 other identifier
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2017
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
August 23, 2018
CompletedFirst Posted
Study publicly available on registry
August 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedFebruary 17, 2020
February 1, 2020
1.9 years
August 23, 2018
February 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ORR
To measure the patients's overall response rate
Approximately 1 years
Secondary Outcomes (2)
PFS
Approximately 1 years
OS
Approximately 1 years
Study Arms (1)
Apatinib Combined With Vinorelbine
EXPERIMENTALApatinib Combined With Vinorelbine Used for Driver Gene Mutation Negative Third-line and Third-line Post Progression Advanced Non-small Cell Lung Cancer
Interventions
Vinorelbine 60mg/m2 d1qweek , Apatinib 500mg po Qd,evaluate every 2months
Eligibility Criteria
You may qualify if:
- ，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
You may not qualify if:
- Patients received apatinib or Vinorelbine treatment before
- EGFR, ALK or ROS1 mutation
- Patients with contraindication of chemotherapy
- Pregnant or breast feeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yongchang Zhanglead
Study Sites (1)
Hunan Provincal Tumor Hospital
Changsha, Hunan, 410013, China
Related Publications (1)
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.
PMID: 32191330DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nong Yang, MD
Hunan Province Tumor Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 23, 2018
First Posted
August 29, 2018
Study Start
January 1, 2017
Primary Completion
November 30, 2018
Study Completion
December 31, 2019
Last Updated
February 17, 2020
Record last verified: 2020-02