NCT01932229

Brief Summary

Advanced lung cancer (non-small cell lung cancer) with a mutation in the EGFR (epidermal growth factor receptor) gene, which have disease progression after treatment with an EGFR inhibitor (erlotinib or gefitinib), and have progression of disease also after treatment with chemotherapy will be recruited. The trial has only one arm, of afatinib daily treatment. Blood and exhaled breath samples will be collected for investigations aiming to identify factors that predict response to afatinib.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

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

February 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Last Updated

August 30, 2013

Status Verified

August 1, 2013

Enrollment Period

1.9 years

First QC Date

August 27, 2013

Last Update Submit

August 29, 2013

Conditions

NSCLC

Keywords

Advanced NSCLCEGFR mutationTKIsTyrosine Kinase Inhibitors

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    One year

Secondary Outcomes (1)

  • Overall survival

    One year

Study Arms (1)

Afatinib treatment

EXPERIMENTAL
Drug: Afatinib treatment

Interventions

Afatinib treatmentDRUG
Afatinib treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced NSCLC
  • EGFR mutation or six months or longer benefit from EGFR TKIs
  • Disease progression on chemotherapy, or inability to receive chemotherapy for medical reasons.
  • Disease progression on EGFR TKI, or the presence of an EGFR mutation that does predicts for poor response to first generation EGFR TKIs.

You may not qualify if:

  • Inability to take oral drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gat, 52621, Israel

RECRUITING

Central Study Contacts

Jair Bar, MD-PhD

CONTACT

+972-3-530-7096

Dina Vornstein, B.A.

CONTACT

Diana.Vorenshtein@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2013

First Posted

August 30, 2013

Study Start

February 1, 2013

Primary Completion

January 1, 2015

Last Updated

August 30, 2013

Record last verified: 2013-08

Locations

IL(1)