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An Open Label Study of BIBW 2992/Afatinib in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib
Conditions
NSCLC
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords
Advanced NSCLC, EGFR mutation, TKIs, Tyrosine Kinase Inhibitors
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Afatinib treatment
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
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.
Exclusion Criteria:
- Inability to take oral drugs
- 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
Location
Sheba Medical Center
Ramat Gat, Israel
Status: Recruiting
Contact: Dina Vornstein - Diana.Vorenshtein@sheba.health.gov.il
Start Date
February 2013
Sponsors
Sheba Medical Center
Source
Sheba Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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