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NCT02988141 Clinical Trial

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

Nonsmall Cell Lung Cancer Clinical Trial

— PRECENT  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02988141
Other study ID # CCTC1601
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 7, 2016
Last updated January 18, 2017
Start date March 2017
Est. completion date February 2021

Study information
Verified date January 2017
Source The First Affiliated Hospital of Guangzhou Medical University
Contact Jian Xing HE, MD
Phone 86-20-83062338
Email yxy701@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date February 2021
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Jianxing He AstraZeneca

Outcome
Type Measure Description Time frame Safety issue
Primary The biomarker profile of EGFR-TKI resistance Baseline
Secondary The concordance, sensitivity and specificity in paired blood and tissue samples Baseline
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