Status:
COMPLETED
Afatinib as Second-line Therapy for Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objectives of this single-arm, open-label trial are to assess the efficacy and safety of afatinib as second line treatment for patients with locally advanced or metastatic non-small cell lung canc...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
- Documented EGFR mutation (L858R and/or Deletion 19) with no other known EGFR mutation.
- Measureable disease according to RECIST 1.1.
- Radiologically confirmed progression or recurrence of disease during or following first line therapy with a platinum-based chemotherapy regimen.
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
- Adequate organ function.
- Exclusion criteria:
- More than one line of prior therapy for disease.
- Previously received less than 3 cycles of platinum-based chemotherapy due to toxicity and/or intolerance of treatment.
- Previous treatment with any EGFR targeting Tyrosine Kinase Inhibitor (TKI) or antibody.
- Known pre-existing interstitial lung disease.
Exclusion
Key Trial Info
Start Date :
October 2 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02208843
Start Date
October 2 2014
End Date
June 13 2017
Last Update
December 17 2018
Active Locations (21)
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1
Clinical Research Center, Alexandria University Hospital
Alexandria, Egypt, 21131
2
National Cancer Institute, Cairo University
Cairo, Egypt, 11796
3
Kasr Al Ainy Hospital
Cairo, Egypt, 12311
4
Nilai Medical Centre
Kampung Baharu Nilai, Malaysia, 71800