Afatinib as Second-line Therapy for Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation

Phase 4

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Afatinib	Afatinib	Afatinib tablet once daily until progression

Primary Outcome Measures

Name	Time	Method
Objective Tumour Response (Complete Response [CR], Partial Response [PR]) as Assessed by the Investigator According to the RECIST Version 1.1	Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days	As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS) as Assessed by the Investigator According to RECIST 1.1.	Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days	Progression-free survival (PFS) is the time from treatment start to disease progression (or death if the patient died before progression). PFS as assessed based on investigator review according to the response evaluation criteria in solid tumours (RECIST) version 1.1.
Disease Control (CR, PR, Stable Disease [SD]) as Assessed by the Investigator According to RECIST 1.1	Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days	As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.

Locations (21): Sf. Nectarie Oncology Center, Craiova
🇷🇴
Craiova, Romania
Institute for Oncol & Radiol of Serbia, Clinic f. Med. Onco.
🇷🇸
Belgrade, Serbia
King Chulalongkorn Memorial Hospital
🇹🇭
Bangkok, Thailand
Songklanagarind Hospital
🇹🇭
Songkhla, Thailand
Braila County Emergency Hospital, Medical Oncology
🇷🇴
Braila, Romania
Rajavithi Hospital
🇹🇭
Bangkok, Thailand
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
Specialist Hospital, Szczecin-Zdunowo
🇵🇱
Szczecin-Zdunowo, Poland
Baguio General Hospital and Medical Center
🇵🇭
Baguio City, Philippines
St. Luke's Medical Center
🇵🇭
Taguig, Philippines
University Clinical Center, Gdansk
🇵🇱
Gdansk, Poland
Oncol Centre M Sklodowska-Curie, Dept of Lung & Chest Cancer
🇵🇱
Warsaw, Poland
Institute of Oncology 'Prof. Dr. Alexandru Trestioreanu'
🇷🇴
Bucharest, Romania
Clinical Center Kragujevac
🇷🇸
Kragujevac, Serbia
Regional Oncology Institute of Iasi, Medical Oncology
🇷🇴
Iasi, Romania
Inst. for Pulm. Diseases of Vojvodine, Clinic f. Pulm. Oncol
🇷🇸
Sremska Kamenica, Serbia
Clinical Center of Serbia
🇷🇸
Belgrade, Serbia
Wattanosoth Hospital
🇹🇭
Bangkok, Thailand