Acquired Resistant Mechanism of the First-generation EGFR TKIs

NCT ID: NCT02804217

Last Updated: 2016-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Non-small Cell Lung Cancer Aquired Resistance EGFR TKIs

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Genetic: mutation profile

Intervention Type OTHER

Other Intervention Names

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Procedure: Lung tumor biopsy Procedure: Blood sample

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yu Xinmin

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ying Jin, MD

Role: CONTACT

86-571-88122082

Facility Contacts

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Xinmin Yu, MD

Role: primary

86-571-88122082

Other Identifiers

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IRB-2016-74

Identifier Type: -

Identifier Source: org_study_id

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