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Study of Anlotinib Combined With Docetaxel in Non-Driver Mutation Non-squamous Non-small Cell Lung Cancer (SAVE)

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ClinicalTrials.gov Identifier: NCT03646968
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Yongchang Zhang, MD, Hunan Province Tumor Hospital

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
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 : August 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel

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)




Primary Outcome Measures :
  1. ORR [ Time Frame: may 2018- may 2019 (1 year) ]
    overall response rate


Secondary Outcome Measures :
  1. PFS [ Time Frame: may 2018- may 2019 (1 year) ]
    Progression survival time

  2. OS [ Time Frame: may 2018- may 2019 (1 year) ]
    overall survival time



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646968


Contacts
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Contact: Yongchang Z MD, MD +8613873123436 ext 7+861383123436 yangnong0217@163.com
Contact: Yongchang Z MD, PhD +8613873123436 ext +8613873123436 zhangyongchang@csu.edu.cn

Locations
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China, Hunan
Hunan Provincal Tumor Hospital Recruiting
Changsha, Hunan, China, 410013
Contact: Nong Yang, MD    +86 731 89762323    yangnong0217@163.com   
Contact: Chunhua Zhou, MD    +86 731 89762321    zhouchunhua@hnszlyy.com   
Principal Investigator: Nong Yang, MD         
Sponsors and Collaborators
Yongchang Zhang, MD

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Responsible Party: Yongchang Zhang, MD, Professor, Hunan Province Tumor Hospital
ClinicalTrials.gov Identifier: NCT03646968     History of Changes
Other Study ID Numbers: ANCVNSNCLC
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yongchang Zhang, MD, Hunan Province Tumor Hospital:
Anlotinib Combined With Docetaxel

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action