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

Yongchang Zhang

Status and phase: Completed; Phase 2

Conditions: Advanced Non Small Cell Lung Cancer

Treatments: Drug: Apatinib Combined With Vinorelbine

Study type: Interventional

Funder types: Other

Identifiers

NCT03652857

VICTOR

Details and patient eligibility

About

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 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Apatinib Combined With Vinorelbine

Experimental group

Description:

Apatinib Combined With Vinorelbine Used for Driver Gene Mutation Negative Third-line and Third-line Post Progression Advanced Non-small Cell Lung Cancer

Treatment:

Drug: Apatinib Combined With Vinorelbine