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

Phase 2

Completed

• Conditions: Advanced Non Small Cell Lung Cancer
• Interventions: Drug: Apatinib Combined With Vinorelbine

• Registration Number: NCT03652857
• Lead Sponsor: Yongchang Zhang

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 Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-24
• Study First Posted: 2018-08-29
• Primary Completion: 2018-11-30
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apatinib Combined With Vinorelbine	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

Primary Outcome Measures

Name	Time	Method
ORR	Approximately 1 years	To measure the patients's overall response rate

Secondary Outcome Measures

Name	Time	Method
PFS	Approximately 1 years	Progression free survival
OS	Approximately 1 years	Overall survival

Trial Locations

Locations (1)

Hunan Provincal Tumor Hospital; 🇨🇳 Changsha, Hunan, China