Study of Anlotinib Combined With Docetaxel in Non-Driver Mutation Non-squamous NSCLC: the Save Study

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

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

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.

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