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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

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

Condition or disease Intervention/treatment Phase
Advanced Non Small Cell Lung Cancer Drug: Apatinib Combined With Vinorelbine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Apatinib Combined With Vinorelbine
Vinorelbine 60mg/m2 d1qweek , Apatinib 500mg po Qd,evaluate every 2months




Primary Outcome Measures :
  1. ORR [ Time Frame: Approximately 1 years ]
    To measure the patients's overall response rate


Secondary Outcome Measures :
  1. PFS [ Time Frame: Approximately 1 years ]
    Progression free survival

  2. OS [ Time Frame: Approximately 1 years ]
    Overall survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652857


Locations
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China, Hunan
Hunan Provincal Tumor Hospital
Changsha, Hunan, China, 410013
Sponsors and Collaborators
Yongchang Zhang
Investigators
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Principal Investigator: Nong Yang, MD Hunan Province Tumor Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yongchang Zhang, Professor, Hunan Province Tumor Hospital
ClinicalTrials.gov Identifier: NCT03652857    
Other Study ID Numbers: VICTOR
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yongchang Zhang, Hunan Province Tumor Hospital:
Apatinib plus Vinorelbine
NSCLC
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Apatinib
Vinorelbine
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators