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

Non-Squamous Non Small Cell Lung Cancer Clinical Trial

— SAVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03646968
• Other study ID #: SAVE
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2018
• Est. completion date: June 1, 2025

Study information

• Verified date: December 2023
• Source: Hunan Province Tumor Hospital
• Contact: Yongchang Zhang, MD
• Phone: +8613873123436
• Email: yangnong0217[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: June 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Squamous Non Small Cell Lung Cancer

Intervention

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)

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Yongchang Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	overall response rate	may 2018- may 2019 (1 year)
Secondary	PFS	Progression survival time	may 2018- may 2019 (1 year)
Secondary	OS	overall survival time	may 2018- may 2019 (1 year)