NCT02988141

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

January 20, 2017

Status Verified

January 1, 2017

Enrollment Period

3.8 years

First QC Date

December 7, 2016

Last Update Submit

January 18, 2017

Conditions

Nonsmall Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • The biomarker profile of EGFR-TKI resistance

    Baseline

Secondary Outcomes (1)

  • The concordance, sensitivity and specificity in paired blood and tissue samples

    Baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

EGFR mutation positive patients with paired tissue and blood samples

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

ctDNA in blood and tissues

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jian Xing HE, MD

    China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Xing HE, MD

CONTACT

86-20-83062338yxy701@126.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

December 7, 2016

First Posted

December 9, 2016

Study Start

March 1, 2017

Primary Completion

December 1, 2020

Study Completion

February 1, 2021

Last Updated

January 20, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share