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

NCT03647592 | Unknown

• 1 other identifier: WECAN
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Keywords

Non-small Cell Lung Cancer; Bevacizumab; Erlotinib/Gefitinib; EGFR mutation positive

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression free survival

  Approximately 1 years

Secondary Outcomes (2)

• OS

  Approximately 1 years

• DCR

  Approximately 1 years

Study Arms (1)

Cohorts 1

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

Drug: Erlotinib/Gefitinib combined with Bevacizumab

Interventions

Erlotinib/Gefitinib combined with Bevacizumab DRUG

Erlotlnib,150mg po qd/gefitinib 250mg po qd +Bevacizumab(15mg/kg),lvgtt,every 21 day ,evaluate every 2 months

Also known as: treatment of A+T

Cohorts 1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• other genes mutation
• saquamous

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (1)

Hunan Provincal Tumor Hospital

Changsha, Hunan, 410013, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tissue sample and plasma DNA

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Bevacizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Yongchang Z MD, MD

CONTACT

+8613873123436; zhangyongchang@csu.edu.cn

Yongchang Z MD, PhD

CONTACT

+8613873123436; zhangyongchang@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 27, 2018
• Study Start: June 1, 2018
• Primary Completion: August 31, 2024
• Study Completion: December 1, 2025
• Last Updated: December 27, 2023

Record last verified: 2023-12

Locations

CN (1)