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Brief Title: Afatinib as Second-line Therapy for Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation
Official Title: An Open Label, Single-arm Phase IV Study to Assess the Efficacy and Safety of Afatinib as Second-line Therapy for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harbouring an EGFR Mutation (Del19 or L858R) Who Have Failed First-line Treatment With Platinum-based Chemotherapy
Study ID: NCT02208843
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 cancer (NSCLC) harbouring a common EGFR mutation who have failed first-line platinum-based chemotherapy and to demonstrate that the efficacy and safety are comparable to the results seen in previous trials.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Clinical Research Center, Alexandria University Hospital, Alexandria, , Egypt
National Cancer Institute, Cairo University, Cairo, , Egypt
Kasr Al Ainy Hospital, Cairo, , Egypt
Nilai Medical Centre, Nilai, , Malaysia
Baguio General Hospital and Medical Center, Baguio City, , Philippines
St. Luke's Medical Center, Taguig, , Philippines
University Clinical Center, Gdansk, Gdansk, , Poland
Specialist Hospital, Szczecin-Zdunowo, Szczecin-Zdunowo, , Poland
Oncol Centre M Sklodowska-Curie, Dept of Lung & Chest Cancer, Warsaw, , Poland
Braila County Emergency Hospital, Medical Oncology, Braila, , Romania
Institute of Oncology 'Prof. Dr. Alexandru Trestioreanu', Bucharest, , Romania
Sf. Nectarie Oncology Center, Craiova, Craiova, , Romania
Regional Oncology Institute of Iasi, Medical Oncology, Iasi, , Romania
Institute for Oncol & Radiol of Serbia, Clinic f. Med. Onco., Belgrade, , Serbia
Clinical Center of Serbia, Belgrade, , Serbia
Clinical Center Kragujevac, Kragujevac, , Serbia
Inst. for Pulm. Diseases of Vojvodine, Clinic f. Pulm. Oncol, Sremska Kamenica, , Serbia
Wattanosoth Hospital, Bangkok, , Thailand
King Chulalongkorn Memorial Hospital, Bangkok, , Thailand
Rajavithi Hospital, Bangkok, , Thailand
Songklanagarind Hospital, Songkhla, , Thailand
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR