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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Advanced Non Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Apatinib Combined With Vinorelbine

Intervention Type DRUG

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

Interventions

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Apatinib Combined With Vinorelbine

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No