Advanced Non Small Cell Lung Cancer
Conditions
Keywords
Apatinib plus Vinorelbine, NSCLC
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.
Interventions
DRUGApatinib Combined With Vinorelbine
Vinorelbine 60mg/m2 d1qweek , Apatinib 500mg po Qd,evaluate every 2months
Sponsors
Yongchang Zhang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | Approximately 1 years | To measure the patients's overall response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | Approximately 1 years | Progression free survival |
| OS | Approximately 1 years | Overall survival |
Countries
China
Outcome results
None listed