Phase II Study to Evaluate the Effectiveness and Safety of Anlotinib Combined With Docetaxel in Progress After First Line Standard Cheomotherapy in Advanced Non-driver Mutation Non- Squamous Non-small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Yongchang Zhang
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- ORR
Overview
Brief Summary
The purpose of this study is to evaluate the Effectiveness and Safety of Anlotinib combined with Docetaxel in Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer
Detailed Description
The purpose of this study is to evaluate the Effectiveness and Safety of Anlotinib combined with Docetaxel in Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer .According to the result of TAX317,the ORR of second line standard chemotherapy was 5- 8%. We expect the ORR was 20%. Using PASS11, we calculated the sample size of this study was 39 , according to 10% censoring,the expected sample size is 43.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18，Pathologically proven Non squamous non small cell lung cancer
- •No-drive gene mutaion (EGFR、ALK、ROS1） by NGS
- •Progress after second line
- •PS score 0-2
Exclusion Criteria
- •Patients received second line treatment
- •Patients received treatment of Anlotinib or Docetaxel
- •Patients with contraindication of chemotherapy
- •Pregnant or breast feeding women
Arms & Interventions
Cohorts
Phase II Study to evaluate the Effectiveness and Safety of Anlotinib combined with Docetaxel in Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer
Intervention: Anlotinib and Docetaxel (Drug)
Outcomes
Primary Outcomes
ORR
Time Frame: may 2018- may 2019 (1 year)
overall response rate
Secondary Outcomes
- PFS(may 2018- may 2019 (1 year))
- OS(may 2018- may 2019 (1 year))
Investigators
Yongchang Zhang
Professor
Hunan Province Tumor Hospital