CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 481 enrolled
Drug / intervention
Afatinibdrug
Likely dose
Afatinib 40 milligramsfrom 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.

Search/NCT01853826
NCT01853826Phase 3Completed
CompareCT.gov

An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)

Boehringer Ingelheim·interventional·Posted May 15, 2013·Updated Apr 11, 2025

In Brief

A Phase 3 clinical trial evaluating Afatinib for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 481 participants across 118 sites in 11 countries.

Detailed Summary

To evaluate the safety and tolerability of afatinib (Giotrif) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s) and have never been treated with an EGFR-TKI

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesAustralia, Austria, Czechia, Greece, Hungary, Israel, Italy, Poland, Portugal, Russia, Spain
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 15, 2013
Enrollment StartJul 17, 2013
Primary CompletionMar 6, 2024
TodayJul 2, 2026
Enrollment to primary: 10.6 yearsPosted 13.1 years ago

Interventions

Afatinibdrug

Patients received a daily dose of 40 milligrams (mg) of afatinib (Giotrif®), in the form of film-coated tablet over a 28 day cycle. Afatinib was taken orally with 250 milliliters (mL) of water at the same time of the day and without eating anything for at least 3 hours. Patients continued on treatment for as long as there was no disease progression or no other trial withdrawal criteria. The dose was reduced to 30 mg or 20 mg once daily when the initial dose was not tolerated by the patient.