Acquired Resistant Mechanism of the First-generation EGFR TKIs

June 18, 2016 updated by: Yu Xinmin, Zhejiang Cancer Hospital

Identification of Genomic Mutation Profile Using Next Generation Sequencing for Non-small-cell Lung Cancer Patients With Activating EGFR Mutations Harboring Acquired Resistance to the First-generation EGFR TKIs.

Patients with advanced non-small-cell lung cancer (NSCLC) harboring sensitive epithelial growth factor receptor (EGFR) mutations invariably develop acquired resistance to EGFR tyrosine kinase inhibitors (TKIs). Identification of actionable genetic mutations can be helpful for guiding the subsequent treatment. This study aimed to analyze the genetic profile of NSCLC harboring acquired resistance to the first-generation EGFR TKIs using next generation sequencing (NGS).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Other: Genetic: mutation profile

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- Zhejiang
  - Hangzhou, Zhejiang, China, 310022
    - Recruiting
    - Zhejiang Cancer Hospital
    - Contact:
      
      Xinmin Yu, MD
      
      Phone Number: 86-571-88122082
      
      Email: yu_xinm@sina.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with NSCLC harboring sensitive EGFR mutations and received first-generation EGFR-TKIs who developed acquired drug resistance

Description

Inclusion Criteria:

Histologically proven stage IIIB or IV non-small cell lung cancer
patients harboring sensitive EGFR mutations and received first-generation EGFR-TKIs who developed acquired drug resistance
patients who can provide pre-treatment (EGFR TKIs) tumor tissues
patients with tumor lesions to be re-biopsy after drug resistance
patients must sign an informed consent indicating that they are aware of the .investigational nature of the study in keeping with the policy of the hospital.

Exclusion Criteria:

History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
patients with other systemic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
mutation profile Time Frame: 10 days	10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria