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Apatinib Combined With Vinorelbine for Non-driver Gene Mutation Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652857
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Yongchang Zhang, Hunan Province Tumor Hospital

Tracking Information
First Submitted Date  ICMJE August 23, 2018
First Posted Date  ICMJE August 29, 2018
Last Update Posted Date February 17, 2020
Actual Study Start Date  ICMJE January 1, 2017
Actual Primary Completion Date November 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2018)
ORR [ Time Frame: Approximately 1 years ]
To measure the patients's overall response rate
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2018)
  • PFS [ Time Frame: Approximately 1 years ]
    Progression free survival
  • OS [ Time Frame: Approximately 1 years ]
    Overall survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Apatinib Combined With Vinorelbine for Non-driver Gene Mutation Non-small Cell Lung Cancer
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Non Small Cell Lung Cancer
Intervention  ICMJE Drug: Apatinib Combined With Vinorelbine
Vinorelbine 60mg/m2 d1qweek , Apatinib 500mg po Qd,evaluate every 2months
Study Arms  ICMJE Experimental: Apatinib Combined With Vinorelbine
Apatinib Combined With Vinorelbine Used for Driver Gene Mutation Negative Third-line and Third-line Post Progression Advanced Non-small Cell Lung Cancer
Intervention: Drug: Apatinib Combined With Vinorelbine
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2019)
30
Original Estimated Enrollment  ICMJE
 (submitted: August 24, 2018)
32
Actual Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date November 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03652857
Other Study ID Numbers  ICMJE VICTOR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yongchang Zhang, Hunan Province Tumor Hospital
Study Sponsor  ICMJE Yongchang Zhang
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nong Yang, MD Hunan Province Tumor Hospital
PRS Account Hunan Province Tumor Hospital
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP