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

Recruiting

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: Erlotinib/Gefitinib combined with Bevacizumab

• Registration Number: NCT03647592
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-27
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-25
• Last Update Posted: 2023-12-27
• Primary Completion: 2024-08-31
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohorts 1	Erlotinib/Gefitinib combined with Bevacizumab	patients with EGFR mutation-positive who received treatment of Erlotinib/Gefitinib Combined With Bevacizumab

Primary Outcome Measures

Name	Time	Method
PFS	Approximately 1 years	Progression free survival

Secondary Outcome Measures

Name	Time	Method
OS	Approximately 1 years	Overall survival
DCR	Approximately 1 years	Disease control rate

Trial Locations

Locations (1)

Hunan Provincal Tumor Hospital; 🇨🇳 Changsha, Hunan, China