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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Non-Squamous Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Anlotinib and Docetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohorts<br>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 | Drug: Anlotinib and Docetaxel<br>* Patients who was Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer recieved the treatment of Anlotinib and Docetaxel (Anlotinib, 12mg, po,qd and Docetaxel 175mg/m2, ivgtt, every 21day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | overall response rate | may 2018- may 2019 (1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression survival time | may 2018- may 2019 (1 year) | 
| OS | overall survival time | may 2018- may 2019 (1 year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anlotinib Combined With Docetaxel