144TiP - 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 meta...

Date 17 April 2015
Event ELCC 2015
Session Poster lunch
Topics Anti-Cancer Agents & Biologic Therapy
Non-Small-Cell Lung Cancer, Metastatic
Presenter Sumitra Thongprasert
Citation Annals of Oncology (2015) 26 (suppl_1): 29-44. 10.1093/annonc/mdv050
Authors S. Thongprasert1, H. Jones2, A. Cseh3, R.M. Gaafar4
  • 1Department Of Medicine, Faculty Of Medicine, Chiang Mai University, 50200 - Chiang Mai/TH
  • 2Oncology Department, Boehringer Ingelheim Ltd., Bracknell/UK
  • 3Oncology Department, Boehringer Ingelheim RCV GmbH & Co KG, 1121 - Vienna/AT
  • 4National Cancer Institute, Cairo University, Cairo/EG



Afatinib, an irreversible ErbB family blocker, is approved in many countries for the treatment of EGFR tyrosine kinase inhibitor (TKI)-naïve adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations, including Del19 and L858R. This indication is based on the results of two large randomized Phase 3 studies that showed superior progression-free survival (PFS), objective response rate and patient-reported outcomes for patients receiving first-line afatinib compared with standard chemotherapy. Recently, both trials also reported significant benefit in overall survival with first-line afatinib in patients with Del19 mutation. However, in some cases, patients are tested for EGFR mutation status subsequent to initiating first-line chemotherapy. This study is investigating the efficacy and safety of second-line afatinib in such patients.

Trial design

The aim of this ongoing single-arm open-label Phase IV trial is to evaluate the efficacy and safety of afatinib as second-line treatment in 60 patients with locally advanced or metastatic NSCLC (stage IIIB or IV) harbouring EGFR mutations, following failure of first-line platinum-based chemotherapy. Patients from centres located across Europe, Asia and North Africa will receive a single oral dose of afatinib 40mg/day until the development of progressive disease. Eligibility criteria include ≥18 years of age; ECOG PS 0–1; documented single Del19 or L858R EGFR mutation. Patients previously treated with any EGFR-targeted TKI or antibody are excluded. The primary endpoint is objective tumour response (complete response [CR], partial response [PR]) according to RECIST v1.1. Secondary endpoints are PFS and disease control (CR, PR, stable disease). All patients who receive at least one dose of afatinib will be included in the analysis of safety. This study is open for accrual; further details are at ClinicalTrials.gov (NCT02208843).


H. Jones and A. Cseh: employee of Boehringer Ingelheim.

R.M. Gaafar: advisory board participation for Pfizer, Boehringer Ingelheim, Eli Lilly and Novartis; and corporate sponsored research for Eli Lilly, Roche, AstraZeneca, Pfizer and Boehringer Ingelheim.

All other authors have declared no conflicts of interest.