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Clinical Trials/NCT02804217
NCT02804217
Unknown
Not Applicable

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.

Zhejiang Cancer Hospital1 site in 1 country60 target enrollmentJune 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Non-small Cell Lung Cancer
Sponsor
Zhejiang Cancer Hospital
Enrollment
60
Locations
1
Primary Endpoint
mutation profile
Last Updated
9 years ago

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
June 2017
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yu Xinmin

Director

Zhejiang Cancer Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

mutation profile

Time Frame: 10 days

Study Sites (1)

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