At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 60 enrolled
Drug / intervention
Afatinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Afatinib for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 60 participants across 21 sites in 7 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesEgypt, Malaysia, Philippines, Poland, Romania, Serbia, Thailand
Collaborators--
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 2014
Enrollment StartOct 2014
Primary CompletionMay 2017
Study CompletionJun 2017
TodayJul 2026
First PostedAug 5, 2014
Enrollment StartOct 2, 2014
Primary CompletionMay 17, 2017
Study CompletionJun 13, 2017
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 11.9 years ago
Interventions
Afatinibdrug
Afatinib tablet once daily until progression