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

January 18, 2017 updated by: Jianxing He

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

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

Study Overview

Status

Unknown

Conditions

Detailed 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).

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jian Xing HE, MD
  • Phone Number: 86-20-83062338
  • Email: yxy701@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

EGFR mutation positive patients with paired tissue and blood samples

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The biomarker profile of EGFR-TKI resistance
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
The concordance, sensitivity and specificity in paired blood and tissue samples
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jianxing He

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Jian Xing HE, MD, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2017

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

December 7, 2016

First Submitted That Met QC Criteria

December 8, 2016

First Posted (Estimate)

December 9, 2016

Study Record Updates

Last Update Posted (Estimate)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCTC1601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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