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

Phase 2

Recruiting

• Conditions: Non-Squamous Non Small Cell Lung Cancer
• Interventions: Drug: Anlotinib and Docetaxel

• Registration Number: NCT03646968
• Lead Sponsor: Yongchang Zhang

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 Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-24
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-25
• Last Update Posted: 2023-12-27
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohorts	Anlotinib and Docetaxel	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

Primary Outcome Measures

Name	Time	Method
ORR	may 2018- may 2019 (1 year)	overall response rate

Secondary Outcome Measures

Name	Time	Method
PFS	may 2018- may 2019 (1 year)	Progression survival time
OS	may 2018- may 2019 (1 year)	overall survival time

Trial Locations

Locations (1)

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China