477TiP - Phase IV study of afatinib as second-line therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring com...

Date 20 December 2015
Event ESMO Asia 2015 Congress
Session Poster presentation 2
Topics Anti-Cancer Agents & Biologic Therapy
Non-Small-Cell Lung Cancer, Metastatic
Presenter Sumitra Thongprasert
Citation Annals of Oncology (2015) 26 (suppl_9): 125-147. 10.1093/annonc/mdv532
Authors S. Thongprasert1, A. Alexandru2, M. Schenker3, A. Abdelaziz4, D.E. Clement5, C. Boldeanu6, D. Jovanovic7, J. Reyes-Igama8, M. Petrović9, S.L. Geater10, D. Radosavljevic11, B. Perin12, M.J. Krzakowski13, P. Serwatowski14, J.D. Parra15, V. Sriuranpong16, H. Jones17, A. Cseh18, R.M. Gaafar19
  • 1Department Of Medicine, Faculty Of Medicine, Chiang Mai University, 50200 - Chiang Mai/TH
  • 2Medical Oncology Department, Oncology Institute of Bucharest, Bucharest/RO
  • 3Department Of Medical Oncology, Oncology Center Sf Nectarie Ltd., Craiova/RO
  • 4Alexandria Clinical Research Centre, Alexandria University, Alexandria/EG
  • 5Medical Oncology, Regional Oncology Institute of Iasi, Iasi/RO
  • 6Brăila County, Emergency Hospital, Braila/RO
  • 7Clinic For Pulmonology, Clinical Center Serbia, Belgrade/RS
  • 8Department Of Medicine, Baguio General Hospital and Medical Center, Baguio City/PH
  • 9Pulmonary Department, Clinical Center Kragujevac, Kragujevac/RS
  • 10Songklanagarind Hospital, Prince of Songkla University, Songkhla/TH
  • 11Clinic For Medical Oncology, Institute for Oncology and Radiology of Serbia, Belgrade/RS
  • 12Faculty Of Medicine, Institute for Pulmonary Diseases of Vojvodine, Sremska Kamenica/RS
  • 13Lung & Thoracic Tumours Department, The Maria Sklodowska-Curie Institute of Oncology, Szczecin/PL
  • 14Chemotherapy Department, Specjalistyczny Szpital im. Prof. Alfreda SokoÅ‚owskiego, Szczecin/PL
  • 15St. Luke’s Medical Center, Bonifacio Global City, Taguig City/PH
  • 16Department Of Medicine, Faculty Of Medicine, Chulalongkorn University & The King Chulalongkorn Memorial Hospital, Bangkok/TH
  • 17Oncology Department, Boehringer Ingelheim Ltd., Bracknell/GB
  • 18Oncology Department, Boehringer Ingelheim RCV GmbH & Co. KG, Vienna/AT
  • 19National Cancer Institute, Cairo University, Cairo/EG

Abstract

Background

Afatinib, an oral, irreversible ErbB family blocker, improved progression-free survival (PFS), objective response rate and symptom control in patients with EGFR mutation-positive locally advanced or metastatic NSCLC, when compared with standard platinum-doublet chemotherapy in the first-line setting. Afatinib also significantly prolonged overall survival in patients with Del19 mutations. Some EGFR mutation-positive patients still receive first-line chemotherapy and there are limited data regarding the effect of afatinib in this patient population. This study was designed to evaluate the efficacy and safety of 40 mg/day afatinib in the second-line setting.

Trial design

This is an ongoing, single-arm, open-label, Phase IV trial to enroll 60 patients with locally advanced or metastatic adenocarcinoma of the lung (stage IIIB/IV) harboring EGFR mutations who have failed first-line platinum-based chemotherapy. Inclusion criteria include age ≥18 years, ECOG PS 0 or 1, and documented EGFR Del19 and/or L858R mutation. Patients previously treated with any EGFR-targeted tyrosine kinase inhibitor or antibody are excluded. Patients from centers across Europe, Asia and North Africa will receive oral afatinib 40 mg/day until the development of progressive disease. The primary endpoint is objective tumor response (complete response [CR], partial response [PR]) according to RECIST v1.1. Secondary endpoints include PFS, disease control (CR, PR, stable disease) and assessment of safety. All patients who received at least one dose of afatinib will be included in the safety analysis. Efficacy and safety will be evaluated in a descriptive manner; there are no formal statistical hypotheses. This trial was initiated in October 2014 and is open for accrual. Study locations include 22 trial sites in 7 countries. Trial sites are currently open to enrollment in Egypt, Romania, Serbia, Malaysia, the Philippines, Poland, and Thailand. The estimated completion date for the primary outcome is December 2016; further details are at ClinicalTrials.gov (NCT02208843).

Clinical trial identification

NCT02208843

Disclosure

D. Jovanovic: membership of advisory board for Boehringer Ingelheim. S. Geater: employment by Prince of Songkla University; advisory board participation for Boehringer Ingelheim; institutional research funds from Boehringer Ingelheim, AstraZeneca, Roche, Teva pharmaceutical and Eisai; and honoraria from Boehringer Ingelheim, Roche and AstraZeneca. M. Krzakowski: advisory board involvement for Boehringer Ingelheim and honoraria from Boehringer Ingelheim. V. Sriuranpong: corporate-sponsored research from Boehringer Ingelheim. H. Jones, A. Cseh: employment with Boehringer Inghelheim. All other authors have declared no conflicts of interest.