An Open Label Study of BIBW 2992/Afatinib in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib
- Registration Number
- NCT01932229
- Lead Sponsor
- Sheba Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
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.
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Exclusion Criteria
- Inability to take oral drugs
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Afatinib treatment Afatinib treatment -
- Primary Outcome Measures
Name Time Method Progression free survival One year
- Secondary Outcome Measures
Name Time Method Overall survival One year
Trial Locations
- Locations (1)
Sheba Medical Center
🇮🇱Ramat Gat, Israel