An Open Label Study of BIBW 2992/Afatinib in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib

Sheba Medical Center1 site in 1 country20 target enrollmentFebruary 2013

ConditionsNSCLC

InterventionsAfatinib treatment

DrugsAfatinib treatment

Overview

Phase: Phase 2
Intervention: Afatinib treatment
Conditions: NSCLC
Sponsor: Sheba Medical Center
Enrollment: 20
Locations: 1
Primary Endpoint: Progression free survival
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2013

End Date

January 2015

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sheba Medical Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.