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Real World Study on Erlotinib/Gefitinib Combined With Bevacizumab in Advanced Non-aquamous Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT03647592
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Yongchang Zhang, Hunan Province Tumor Hospital

Brief Summary:
This study aims to explore the efficacy and safety of Erlotinib/Gefitinib combined with bevacizumab in the real world for advanced non-squamous cell lung cancer with EGFR mutation, explore new drug resistance mechanisms under the A+T regimen and consistency between plasma and tissue detection driving genes, and finally assess the predictive value of plasma dynamic detection driving gene mutation profiles in predicting disease. The role of disease progression risk.

Condition or disease Intervention/treatment
Efficacy and Safety of Erlotinib/Gefitinib Combined With Bevacizumab in EGFR Mutation Positive Advanced Non-squamous Non-small Cell Lung Cancer Drug: Erlotinib/Gefitinib combined with Bevacizumab

Detailed Description:
A retrospective study of 30 cases of advanced non-squamous non-small cell lung cancer (NSCLC) with EGFR mutation positive treated with A+T was conducted to observe the efficacy and safety of A+T regimen in the real world. Exploratory research contents are as follows: 1. Consistency between tissue gene test (NGS) and plasma gene test (NGS) at the initial diagnosis; 2. Consistency between tissue gene test (NGS) and plasma gene test (NGS) at the progression of A + T treatment; 3. New drug resistance mechanism of A + T treatment; 4. Plasma dynamics during A + T treatment. Detection (the first efficacy evaluation and a blood sampling before imaging PD) exploration and imaging progress sequence; 5. Plasma large panel dynamic drive gene mutation spectrum analysis to build disease progression risk model.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Real World Study to Evaluate the Efficacy and Resistant Mechanism of Erlotinib/Gefitinib Combined With Bevacizumab in First Line EGFR Mutation Positive Advanced Non-aquamous Non-small Cell Lung Cancer
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort Intervention/treatment
Cohorts 1 Drug: Erlotinib/Gefitinib combined with Bevacizumab
Erlotlnib,150mg po qd/gefitinib 250mg po qd +Bevacizumab(15mg/kg),lvgtt,every 21 day ,evaluate every 2 months




Primary Outcome Measures :
  1. PFS [ Time Frame: Approximately 1 years ]
    Progression free survival


Secondary Outcome Measures :
  1. OS [ Time Frame: Approximately 1 years ]
    Overall survival

  2. DCR [ Time Frame: Approximately 1 years ]
    Disease control rate


Biospecimen Retention:   Samples With DNA
tissue sample and plasma DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

30 non-saquamous non-small cell lung cancer with EGFR mutation positive (19del/L858R) were inrolled in this study.

ECOG PS 0-1 All the patients recieved the treatment of erlotinib combined with Bevacizumab.

Criteria

Inclusion Criteria:

  • EGFR mutation(19del/L858R)
  • advanced non-saquamous non-small cell lung cancer
  • primary treatment of first diagnosis
  • performance status(0-1)

Exclusion Criteria:

  • other genes mutation
  • saquamous

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): NCT03647592


Contacts
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Contact: Yongchang Z MD, MD +8613873123436 ext 7+861383123436 zhangyongchang@csu.edu.cn
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   
Sub-Investigator: Nong Yang, MD         
Sponsors and Collaborators
Hunan Province Tumor Hospital

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Responsible Party: Yongchang Zhang, professor, Hunan Province Tumor Hospital
ClinicalTrials.gov Identifier: NCT03647592     History of Changes
Other Study ID Numbers: WECAN
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019

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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, Hunan Province Tumor Hospital:
Non-small Cell Lung Cancer
Bevacizumab
Erlotinib/Gefitinib
EGFR mutation positive

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
Bevacizumab
Erlotinib Hydrochloride
Gefitinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action