EGFR-TKI Resistance Profile in Chinese Patients With Advanced EGFRm+ NSCLC

NCT ID: NCT02988141

Last Updated: 2017-01-20

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

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-31

Study Completion Date

2021-02-28

Brief Summary

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A Prospective Multi-center Study to Investigate the EGFR-TKI Resistance Profile in Chinese Patients with Advanced EGFRm+ NSCLC

Detailed Description

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Patients with EGFR mutation and presented secondary resistance to prior first-generation EGFR-TKI should have received biopsy of at least on progressed lesions and are able to provide tissues for pathological examination and NGS testing.All enrolled patients will be followed up to clinical outcome (treatments, tumor response, survival, etc).

Conditions

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Nonsmall Cell Lung Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent prior to any study specific procedures.
* Male or female patients aged 18 years and older.
* Histological confirmation of stage IIIB/IV NSCLC.
* Documented EGFR mutation positive .
* WHO Performance Status 0, 1 or 2

Exclusion Criteria

* Any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study.
* Previous (within 6 months) or current treatment with AZD9291.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Jianxing He

OTHER

Sponsor Role lead

Responsible Party

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Jianxing He

Principle Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jian Xing HE, MD

Role: PRINCIPAL_INVESTIGATOR

China

Central Contacts

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Jian Xing HE, MD

Role: CONTACT

86-20-83062338 ext. 0

Other Identifiers

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CCTC1601

Identifier Type: -

Identifier Source: org_study_id

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