Acquired Resistant Mechanism of the First-generation EGFR TKIs

Non-small Cell Lung Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02804217
• Other study ID #: IRB-2016-74
• Status: Recruiting
• Phase: N/A
• First received: June 14, 2016
• Last updated: June 18, 2016
• Start date: June 2016

Study information

• Verified date: June 2016
• Source: Zhejiang Cancer Hospital
• Contact: Ying Jin, MD
• Phone: 86-571-88122082
• Email: jinying_1987[@]sina.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aquired Resistance
• Carcinoma, Non-Small-Cell Lung
• EGFR TKIs
• Non-small Cell Lung Cancer

Intervention

Other:
• Genetic: mutation profile

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mutation profile		10 days	No