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Poster presentation 2

751 - Phase III study of afatinib vs methotrexate (MTX) for second-line recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) patients after platinum-based chemotherapy (CT) in Asia/Middle East/North Africa: LUX-Head & Neck 3 (LUX-H&N3)


20 Dec 2015


Poster presentation 2


Ping Zhang Tang


Annals of Oncology (2015) 26 (suppl_9): 93-102. 10.1093/annonc/mdv527


P.Z. Tang1, M.A. Ahn2, Q. Zhang3, A. Chan4, S.B. Kim5, C. Wang6, X. He7, W. Guo8, J.H. Kang9, A. Dechaphunkul10, P. Li11, A. Kandil12, E.E.W. Cohen13, G. Hu14, Y. Geng15, E. Ehrnrooth16, Y. Guo17

Author affiliations

  • 1 Cancer Institute & Hospital, Chinese Academy of Medical Sciences, 100021 - Beijing/CN
  • 2 Samsung Medical Centre, Sungkyunkwan University School of Medicine, Seoul/KR
  • 3 Department Of Medical Oncology, The Third Affiliated Hospital of Harbin Medical University, Harbin/CN
  • 4 Sir Yk Pao Centre For Cancer, The Chinese University of Hong Kong, Hong Kong/CN
  • 5 Asan Medical Center, University of Ulsan College of Medicine, Seoul/KR
  • 6 Department Of Cancer Center, Chang Gung Memorial Hospital- Keelung, Taipei/TW
  • 7 Cancer Hospital, Chinese Academy of Medical Science, Beijing/CN
  • 8 Department Of Oral And Maxillofacial Surgery, Shanghai Ninth People's Hospital, Shanghai/CN
  • 9 The Catholic University Of Korea, Seoul St. Mary's Hospital, Seoul/KR
  • 10 Department Of Internal Medicine, Prince of Songkla University, Songkhla/TH
  • 11 West China Hospital, Sichuan University, Chengdu/CN
  • 12 Faculty Of Medicine, Alexandria University School of Medicine, Alexandria/EG
  • 13 Department Of Medicine, University of California San Diego Moores Cancer Center, La Jolla/US
  • 14 Clinical Operations, Boehringer Ingelheim (China) Investment Co., Shanghai/CN
  • 15 Biometrics & Data Management, Boehringer Ingelheim (China) Investment Co., Shanghai/CN
  • 16 Ta Oncology, Boehringer Ingelheim, Danmark A/S/DK
  • 17 Shanghai Cancer Center, Fudan University, Shanghai/CN


Abstract 751


HNSCC patients who progress after first-line platinum-based CT for R/M disease have few treatment options. In the Phase III LUX-H&N1 trial, afatinib, an irreversible ErbB family blocker, significantly improved progression-free survival (PFS) and health-related quality of life (HRQoL) compared with MTX in this patient population (Machiels et al, Lancet Oncol 2015). The LUX-H&N3 trial, sharing a similar study design, evaluates afatinib vs MTX in the same treatment setting in patients in Asia/Middle East/North Africa.

Trial design

LUX-H&N3 is a Phase III, open-label, randomized trial evaluating efficacy and safety of afatinib vs MTX in R/M HNSCC patients progressing on/after first-line platinum-based CT (NCT01856478). Key eligibility criteria: age ≥18 years; ECOG PS 0 or 1; histologically or cytologically confirmed R/M HNSCC not amenable for salvage surgery or radiotherapy; documented progressive disease (PD) after ≥2 cycles of cisplatin/carboplatin for R/M disease (>1 systemic therapy not allowed). Prior treatment with EGFR-targeted antibody therapy but not EGFR-targeted small molecules is allowed. Patients are randomized 2:1 to afatinib (40 mg/day orally) or MTX (40 mg/m2 IV weekly), stratified by ECOG PS (0/1) and prior EGFR-targeted antibody therapy in the R/M setting (Yes/No). The initial afatinib dose must be escalated to 50 mg after ≥4 weeks with minimal drug-related adverse events (AEs), or reduced by 10 mg decrements to a minimum of 20 mg in case of drug-related grade ≥3 or selected grade 1/2 AEs. The MTX dose can be escalated to 50 mg/m2, or reduced by 10 mg/m2 decrements to a minimum of 20 mg/m2 in case of drug-related grade ≥2 or selected grade >1 AEs. Treatment will continue until PD or intolerable AEs. Treatment may continue beyond PD in case of clinical benefit as judged by the investigator. The primary endpoint is PFS; secondary endpoints include overall survival, objective response, HRQoL, and safety. Target enrollment is 300 patients; recruitment is ongoing.

Clinical trial identification



M.-J. Ahn: involvement with an advisory board for BMS, ARIAD and Lilly.

A. Chan: advisory board involvement with Merck and Pfizer and research funding from Merck, Eli Lilly, Boehringer Ingelheim and Amgen. J.H. Kang: advisory board involvement with Boehringer Ingelheim, Eli Lilly, Pfizer and ONO Pharmaceutical Co.; corporate-sponsored research for Eli Lilly; and honoraria from Pfizer, Novartis and Boehringer Ingelheim. E. Cohen: involvement with an advisory board for Merck and Pfizer and honoraria from Eisai and Bayer. G.-Q. Hu, Y. Geng, E. Ehrnrooth: employment with Boehringer Ingelheim.

All other authors have declared no conflicts of interest.

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