Study on Potential Biomarkers Associated With Clinical Phenotype of EGFR-TKIs in No-small Cell Lung Cancer in China

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT02381808
• Lead Sponsor: Guangdong Association of Clinical Trials

Brief Summary

To understand 295 gene mutation mutation status (include EGFR, HER2, KRAS, BRAF, PIK3CA,ect) by deep sequencing in Chinese patients with pulmonary adenocarcinoma and their relationships with the patients' clinical features (including sex, age, smoking history and adenocarcinoma subtype), specify the predictive significance of the genes mutations for new targeted therapies in NSCLC patients, and better understand the molecular mechanism drug resistance to EGFR-TKIs.

Detailed Description

This study is prospective to identify biomarkers to resistant to afatinib，gefitinib and erlotinib in non-small cell lung cancer patients. Mutations of whole exon of 295 gene are analysed by deep sequencing in Chinese patients with non-small cell lung cancer and their relationships with the patients' clinical features (including sex, age, smoking history and adenocarcinoma subtype), specify the predictive significance of the genes mutations for new targeted therapies in NSCLC patients, and better understand the molecular mechanism drug resistance to EGFR-TKIs.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-03-05
• Study First Submitted QC: 2015-03-05
• Study First Posted: 2015-03-06
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-05
• Last Update Posted: 2017-06-07
• Primary Completion: 2017-06-24
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Age>18 years,both male and female
• Histologically confirmed patients with pulmonary adenocarcinoma (Stage I-IV)
• ECOG 0-2
• Patients with enough paraffin tissue specimens or fresh tissue for detection
• Quality of the DNA extracted from the tissue samples ensures that the DNA can be used in DNA sequencing
• Subjects who provide detailed clinical and follow-up information

Exclusion Criteria

• Patients with other tumors
• Patients suffering from other serious diseases like infectious diseases (viral hepatitis, HIV,etc)
• Pregnant women shall be excluded

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Potential predictive biomarker to resistant to afatinib	baseline	Mutations of whole exon of 295 gene are analysed by deep sequencing in Chinese patients with NSCLC and their relationships with the patients' clinical features , specify the predictive significance of the genes mutations for new targeted therapies in NSCLC patients, and better understand the molecular mechanism drug resistance to EGFR-TKIs

Trial Locations

Locations (1)

Guangdong General Hospital & Guangdong Academy of Medical Sciences; 🇨🇳 Guangzhou, Guangdong, China