NCT01776684

Brief Summary

To detect resistance gene from serially collected plasma DNA in non-small cell lung cancer harbouring EGFR activating mutation who are being treated with EGFR TKIs by using castPCR method.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

June 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

January 28, 2013

Status Verified

January 1, 2013

Enrollment Period

1.9 years

First QC Date

January 23, 2013

Last Update Submit

January 25, 2013

Conditions

EGFR Mutation Positive Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • detection of resistant gene

    To evaluate the efficiency of castPCR method for detection of resistance genes, especially, T790M mutation from serially collected plasma DNA in non-small cell lung cancer patients harboring EGFR activating mutation who are being treated with EGFR TKIs

    24 months

Study Arms (1)

EGFR positive arm

EXPERIMENTAL

Patients with NSCLC harboring activating EGFR mutation (deletion in exon 19, L858R mutation in exon 21)

Drug: EGFR TKIs (gefitinib, erlotinib, afatinib, et al)

Interventions

EGFR TKIs (gefitinib, erlotinib, afatinib, et al)DRUG
EGFR positive arm

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Histologically confirmed NSCLC 2. Aged of or older than 20 years 3. ECOG performance status 0-2 4. Adequate hematological, renal, hepatic function 5. Patients with tumors harboring EGFR mutation (del 19 or L858R mutation) 6. Patient who are about to be treated with EGFR TKI (gefitinib, erlotinib or other EGFR TKI) 7. At least more than one measurable disease 8. Informed consent

You may not qualify if:

  • \. Active infection 2. Active bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Interventions

GefitinibErlotinib HydrochlorideAfatinib

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAmidesOrganic Chemicals

Central Study Contacts

Myung-Ju Ahn, M.D., Ph.D.

CONTACT

silkahn@skku.edu

Jong-Mu Sun, M.D., Ph.D.

CONTACT

tntntn3@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Professor

Study Record Dates

First Submitted

January 23, 2013

First Posted

January 28, 2013

Study Start

June 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2015

Last Updated

January 28, 2013

Record last verified: 2013-01

Locations

KR(1)