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

Overview

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

Full Title of Study: “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”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: November 30, 2018

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.

Interventions

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

Arms, Groups and Cohorts

• 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

Clinical Trial Outcome Measures

Primary Measures

• ORR
  • Time Frame: Approximately 1 years
  • To measure the patients’s overall response rate

Secondary Measures

• PFS
  • Time Frame: Approximately 1 years
  • Progression free survival
• OS
  • Time Frame: Approximately 1 years
  • Overall survival

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Yongchang Zhang
• Provider of Information About this Clinical Study
  • Sponsor-Investigator: Yongchang Zhang, Professor – Hunan Province Tumor Hospital
• Overall Official(s)
  • Nong Yang, MD, Principal Investigator, Hunan Province Tumor Hospital