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

Sponsor

Hunan Province Tumor Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03647592

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational

Anticipated 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 :

Jun 1, 2018

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Cohorts 1 patients with EGFR mutation-positive who received treatment of Erlotinib/Gefitinib Combined With Bevacizumab	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 Other Names: treatment of A+T

Arm

Intervention/Treatment

Cohorts 1

patients with EGFR mutation-positive who received treatment of Erlotinib/Gefitinib Combined With Bevacizumab

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

Other Names:

treatment of A+T

Outcome Measures

Primary Outcome Measures

PFS [Approximately 1 years]
Progression free survival

Secondary Outcome Measures

OS [Approximately 1 years]
Overall survival
DCR [Approximately 1 years]
Disease control rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

Hunan Province Tumor Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yongchang Zhang, professor, Hunan Province Tumor Hospital

ClinicalTrials.gov Identifier:

NCT03647592

Other Study ID Numbers:

WECAN

First Posted:

Aug 27, 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

Non-small Cell Lung Cancer

Bevacizumab

Erlotinib/Gefitinib

EGFR mutation positive

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Bevacizumab

Erlotinib Hydrochloride

Gefitinib

Study Results

No Results Posted as of Mar 2, 2022