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

Sponsor

Yongchang Zhang (Other)

Overall Status

Recruiting

CT.gov ID

NCT03646968

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Non-Squamous Non Small Cell Lung Cancer	Drug: Anlotinib and Docetaxel	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

43 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohorts 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 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)

Arm

Intervention/Treatment

Experimental: Cohorts

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

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)

Outcome Measures

Primary Outcome Measures

ORR [may 2018- may 2019 (1 year)]
overall response rate

Secondary Outcome Measures

PFS [may 2018- may 2019 (1 year)]
Progression survival time
OS [may 2018- may 2019 (1 year)]
overall survival time

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hunan Cancer Hospital	Changsha	Hunan	China	410013

Sponsors and Collaborators

Yongchang Zhang

Investigators

Principal Investigator: Yongchang Zhang, MD, Hunan Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yongchang Zhang, Professor, Hunan Province Tumor Hospital

ClinicalTrials.gov Identifier:

NCT03646968

Other Study ID Numbers:

SAVE

First Posted:

Aug 24, 2018

Last Update Posted:

Mar 2, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yongchang Zhang, Professor, Hunan Province Tumor Hospital

Anlotinib Combined With Docetaxel

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Docetaxel

Study Results

No Results Posted as of Mar 2, 2022