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

February 12, 2020 updated by: Yongchang Zhang

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Provincal Tumor Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: Approximately 1 years
To measure the patients's overall response rate
Approximately 1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: Approximately 1 years
Progression free survival
Approximately 1 years
OS
Time Frame: Approximately 1 years
Overall survival
Approximately 1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yongchang Zhang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

August 23, 2018

First Submitted That Met QC Criteria

August 24, 2018

First Posted (Actual)

August 29, 2018

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICTOR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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