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

Advanced Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03652857
• Other study ID #: VICTOR
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: Hunan Province Tumor Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Non Small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Hunan Provincal Tumor Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Yongchang Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	To measure the patients's overall response rate	Approximately 1 years
Secondary	PFS	Progression free survival	Approximately 1 years
Secondary	OS	Overall survival	Approximately 1 years