Skip to main content
OpenTrials
Completed

NCT Number: NCT03652857

Apatinib Combined With Vinorelbine for Non-driver Gene Mutation 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Non Small Cell Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hunan Provincal Tumor Hospital

Changsha, Hunan, 410013, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apatinib Combined With Vinorelbine

Drug

Vinorelbine 60mg/m2 d1qweek , Apatinib 500mg po Qd,evaluate every 2months

Primary outcomes

  1. ORR

    Time frame: Approximately 1 years

    To measure the patients's overall response rate

Secondary outcomes

  1. PFS

    Time frame: Approximately 1 years

    Progression free survival

  2. OS

    Time frame: Approximately 1 years

    Overall survival

Sponsors and collaborators

Lead sponsor

Yongchang Zhang

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 29, 2018
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.