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Trial Title:
An Open Label Study of BIBW 2992/Afatinib in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib
NCT ID:
NCT01932229
Condition:
NSCLC
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Afatinib
Conditions: Keywords:
Advanced NSCLC
EGFR mutation
TKIs
Tyrosine Kinase Inhibitors
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Afatinib treatment
Arm group label:
Afatinib treatment
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:
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sheba Medical Center
Address:
City:
Ramat Gat
Zip:
52621
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Dina Vornstein
Email:
Diana.Vorenshtein@sheba.health.gov.il
Investigator:
Last name:
Jair Bar, MD-PhD
Email:
Principal Investigator
Start date:
February 2013
Lead sponsor:
Agency:
Sheba Medical Center
Agency class:
Other
Source:
Sheba Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01932229
