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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Yongchang Z MD, MD; Phone Number: 7+861383123436 +8613873123436; Email: zhangyongchang@csu.edu.cn
• Study Contact Backup: Name: Yongchang Z MD, PhD; Phone Number: +8613873123436 +8613873123436; Email: zhangyongchang@csu.edu.cn

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Hunan Provincal Tumor Hospital
      • Contact: Chunhua Zhou, MD; Phone Number: +86 731 89762321; Email: zhouchunhua@hnszlyy.com
      • Sub-Investigator: Nong Yang, MD
      • Contact: Nong Yang, MD; Phone Number: +86 731 89762323; Email: yangnong0217@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression free survival	Approximately 1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall survival	Approximately 1 years
DCR	Disease control rate	Approximately 1 years

Collaborators and Investigators

• Sponsor: Hunan Province Tumor Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 27, 2018

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 25, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Bevacizumab; Non-small Cell Lung Cancer; EGFR mutation positive; Erlotinib/Gefitinib
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Erlotinib Hydrochloride; Gefitinib; Bevacizumab
• Other Study ID Numbers: WECAN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No