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NCT01932229 Clinical Trial

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

NSCLC Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01932229
Other study ID # SHEBA-12-9547-JB-CTIL
Secondary ID
Status Recruiting
Phase Phase 2
First received August 27, 2013
Last updated August 29, 2013
Start date February 2013

Study information
Verified date August 2013
Source Sheba Medical Center
Contact Jair Bar, MD-PhD
Phone +972-3-530-7096
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Exclusion Criteria:

- Inability to take oral drugs

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Afatinib treatment

Locations
Country Name City State
Israel Sheba Medical Center Ramat Gat

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression free survival One year No
Secondary Overall survival One year Yes
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