At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 542 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, Multicentre, Single Arm Trial to Assess the Safety of Afatinib for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)
In Brief
A Phase 3 clinical trial evaluating Afatinib for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 542 participants across 33 sites in 5 countries.
Detailed Summary
Primary objective of the trial is to evaluate the safety of afatinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR (Epidermal growth factor receptor) mutation(s) and have never been treated with an EGFR-TKI (tyrosine kinase inhibitor). Secondary objective is to assess the time to symptomatic progression (as judged by investigator).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesChina, Hong Kong, India, Singapore, Taiwan
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartSep 2013
First PostedOct 2013
Primary CompletionJul 2018
TodayJul 2026
First PostedOct 1, 2013
Enrollment StartSep 30, 2013
Primary CompletionJul 6, 2018
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 12.8 years ago
Interventions
Afatinibdrug
Patient will receive afatinib once daily