Tecemotide (L-BLP25) versus placebo after chemoradiotherapy for stage III non-small-cell lung cancer (START): a randomised, double-blind, phase 3 trial
Charles Butts, Mark A Socinski, Paul L Mitchell, Nick Thatcher, Libor Havel, Maciej Krzakowski, Sergiusz Nawrocki, Tudor-Eliade Ciuleanu, Lionel Bosquee, Jose Manuel Trigo, Alexander Spira, Lise Tremblay, Jan Nyman, Rodryg Ramlau, Gun Wickart-Johansson, Peter Ellis, Oleg Gladkov, Jose Rodrigues Pereira, Wilfried Ernst Erich Eberhardt, Christoph Helwig Show all
The Lancet Oncology | ELSEVIER SCIENCE INC | Published : 2014
BACKGROUND: Effective maintenance therapies after chemoradiotherapy for lung cancer are lacking. Our aim was to investigate whether the MUC1 antigen-specific cancer immunotherapy tecemotide improves survival in patients with stage III unresectable non-small-cell lung cancer when given as maintenance therapy after chemoradiation. METHODS: The phase 3 START trial was an international, randomised, double-blind trial that recruited patients with unresectable stage III non-small-cell lung cancer who had completed chemoradiotherapy within the 4-12 week window before randomisation and received confirmation of stable disease or objective response. Patients were stratified by stage (IIIA vs IIIB), re..View full abstract
This trial was sponsored by Merck KGaA, Darmstadt, Germany. We thank the patients and their families and the investigators and study teams involved. Medical writing assistance was provided by Paola Accalai (International Medical Press, London, UK) and was funded by Merck KGaA.