NCT03646968

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Yongchang Zhang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Squamous Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Anlotinib and Docetaxel	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)

Timeline

• Start date: 2018-08-01
• Primary completion: 2024-12-31
• Completion: 2025-06-01
• First posted: 2018-08-24
• Last updated: 2023-12-27

Locations

1 site across 1 country: China