Supplementary appendix This appendix formed part of the original submission and has been peer reviewed. We post it as supplied by the authors. Supplement to: Ellis PM, Shepherd FA, Millwaråd M, et al, on behalf of the NCIC CTG, Australasian Lung Cancer Trials Group, and the NCI Naples Clinical Trials Unit. Dacomitinib compared with placebo in pretreated patients with advanced or metastatic non-small-cell lung cancer (NCIC CTG BR.26): a double-blind, randomised, phase 3 trial. Lancet Oncol 2014; published online Oct 15. http://dx.doi.org/10.1016/S14702045(14)70472-3 Appendix 1: Participating institutions Institution Name University Health Network-Princess Margaret Hospital BCCA - Vancouver Cancer Centre Yonsei University College of Medicine Yonsei Cancer Centre Oncologia Medica Toraco Polmonare, Istituto Nazionale Tumori "Fondazione G. Pascale" - IRCCS Juravinski Cancer Centre at Hamilton Health Sciences Ottawa Hospital Research Institute City Toronto Vancouver Seoul Napoli Hamilton Ottawa Country BR26 Role Centre Accrual Investigator Name PI Dr. Geoffrey Liu SI Dr. Frances Shepherd SI Dr. Natasha Leighl SI Dr. Ronald Feld PI Dr. Sophie Sun SI Dr. Janessa J. Laskin SI Dr. Barbara Melosky SI Dr. Cheryl Ho SI Dr. Emma Beardsley SI Dr. Nevin Murray PI Dr. Joo Hang Kim SI Dr. Byoung Chul Cho PI Dr. Alessandro Morabito SI Dr. Raffaele Costanzo SI Dr. Agnese Montanino SI Dr. Pasqualina Giordano SI Dr. Claudia Sandomenico PI Dr. Peter Ellis SI Dr. Andrew Arnold SI Dr. Callista Phillips SI Dr. John Goffin PI Dr. Paul Wheatley-Price SI Dr. Garth Nicholas SI Dr. Glenwood Goss Canada 76 Canada 48 South Korea Italy 31 30 Canada Canada 28 28 1 R.S. McLaughlin DRCC CHUM - Hopital Notre-Dame Cross Cancer Institute McGill University - Dept. Oncology U.O. Oncologia Medica II Istituto Oncologico Veneto Oshawa Montreal Edmonton Montreal Padova Canada Canada Canada Canada SI Dr. Scott Laurie PI Dr. Rafal Wierzbicki PI Dr. Normand Blais SI Dr. Moustapha Tehfe SI Dr. Marie Florescu PI Dr. Randeep Sangha SI Dr. Anil A. Joy SI Dr. Charles Butts SI Dr. Michael Smylie SI Dr. Quincy Chu PI Dr. Victor Cohen SI Dr. Jason Scott Agulnik SI Dr. Richard Dalfen SI Dr. Scott Owen SI Dr. Vera Hirsh PI Dr. Adolfo Favaretto SI Dr. Laura Bonanno SI Dr. Giulia Pasello SI Dr. Cristina Magro 22 18 18 18 Italy 18 The Catholic University of Korea, Seoul St. Mary's Hospital Seoul South Korea PI Dr. Jin-Hyoung Kang 17 Makati Medical Center Makati City Philippines PI Dr. Joseph Parra 15 PI Dr. Young-Chul Kim SI Dr. Kyu-Sik Kim SI Dr. In-Jae Oh PI Dr. Jennifer Sandoval-Tan SI Dr. Carina Chavente PI Dr. Virote Sriuranpong Chonnan National University Hwasun Hospital Phillippine General Hospital Section of Medical Oncology Chulalongkorn University Division of Medical Oncology Jeonnam Manila Bangkok South Korea 15 Philippines Thailand 14 14 2 Department of Medicine Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS Royal Prince Alfred Hospital BCCA - Fraser Valley Cancer Centre Meldola Camperdown Surrey GRAM - Grupo de Assistência Médica e Prestação de Serviço, São Sao Paulo Paulo - Brazil U.O.C di Pneumologia Oncologica I, Azienda Ospedaliera S. Camillo-Forlanini U.O. di Oncologia Ospedale Villa Scassi Auckland City Hospital Rome Genova Auckland SI Dr. Chanida Vinayanuwattikun PI Dr. Dino Amadori SI Dr. Marco Angelo Burgio SI Dr. Giovenzio Genestreti SI Dr. Nada Riva PI Prof. Michael Boyer SI Dr. Lisa Horvath PI Dr. Christopher W. Lee SI Dr. Angela Chan SI Dr. Balvindar S. Johal SI Dr. Thuan Do PI Dr. Jose R. Pereira SI Dr. Sueli Mayumi Nikaedo SI Dr. João Daniel Carneiro França PI Dr. Filippo De Marinis PI Dr. Maria Rita Migliorino SI Dr. Serena Ricciardi SI Dr. Alberto Fulvi PI Dr. Manlio Mencoboni SI Dr. Marina Bergaglio SI Dr. Andrea Bruzzone SI Dr. Lisette Del Corso PI Dr. Rita Sasidharan SI Dr. Dragan Damianovich SI Dr. Richard Sullivan Italy 13 Australia 12 Canada Brazil 12 11 Italy 11 Italy New Zealand 11 11 Maharaj Nakorn Chiangmai Hospital Chiangmai University Chiangmai Thailand PI Dr. Sumitra Thongprasert 11 Ramathibodi Hospital Oncology Unit, Dept. of Medicine Bangkok Thailand PI Dr. Vorachai Ratanatharathorn 11 3 Fundação Pio XII - Hospital de Câncer de Barretos Saint John Regional Hospital China Medical University Hospital Barretos Saint John Taichung SI Dr. Touch Ativitavas PI Dr. Jose Miziara SI Dr. Luciano de Souza Viana SI Dr. Carlos Maciel da Silva SI Dr. Danielle Calheiros Campelo Maia SI Dr. Gustavo Dix Junqueira Pinto SI Dr. Maximiliano Cadamuro Neto PI Dr. Tony Reiman PI Dr. Te-Chun Hsia SI Dr. Hung-Jen Chen SI Dr. Chih-Yen Tu Brazil Canada Taiwan 10 9 9 Peninsula Oncology Centre Frankston Australia PI Dr. Vinod Ganju 8 St. George Hospital Kogarah Australia PI A/Prof. Matthew Links 8 PI Dr. Fabio Andre Franke SI Dr. Flávia Bianchin PI Dr. Peter Briggs SI Dr. Ben Markman PI Prof. Michael John Millward SI Dr. Kevin Jasas SI Dr. Arman Hasani PI Dr. Sunil K. Yadav SI Dr. Florence Plaza Arnold SI Dr. Kamal Haider PI Dr. Francesco Rosetti SI Dr. Mario Bari SI Dr. Donata Sartori PI Dr. Mirta Varela Associação Hospital de Caridade de Ijui - CACON (Centro de Alta Ijuí Complexidade em Oncologia) Brazil Monash Medical Centre Australia Sir Charles Gairdner Hospital Saskatoon Cancer Centre U.O.C. di Oncologia U.L.S.S. 13 Divisione di Oncologia Medica Centro de Oncología e Investigación Buenos Aires (COIBA) Clayton Nedlands Saskatoon Mirano Buenos Aires Australia Canada Italy Argentina 8 7 7 7 7 6 4 The Prince Charles Hospital Allan Blair Cancer Centre Chermside Regina PI Dr. Jeffrey C.H. Goh SI Dr. Brett G. M. Hughes PI Dr. Muhammad Salim SI Dr. A. Saranya Kakumanu SI Dr. Haji Ibrahim Chalchal SI Dr. Miroslav T. Jancewicz SI Dr. Vamsee Torri Australia Canada 6 6 Seoul Veterans Hospital Seoul South Korea PI Dr. Bong-Seog Kim 6 Siriraj Hospital, Oncology Unit Bangkok Thailand PI Dr. Vichien Srimuninnimit 6 Austin Health Heidelberg Australia PI Dr. Thomas John 5 PI Prof. Michael Paul Brown SI Dr. Nimit Singhal SI Dr. Sudarsha Selva-Nayagam PI Dr. Rina Hui PI Dr. Alan Azambuja SI Dr. Christina Oppermann PI Dr. Chaudhary Ejaz Ahmad SI Dr. Joy McCarthy SI Dr. Stewart Rorke PI Dr. Wojciech Morzycki SI Dr. Mary MacNeil SI Dr. Stephanie Snow PI Dr. Chao-Hsun Chen SI Dr. Chao-Jung Tsao SI Dr Wen-Tsung Tuang Royal Adelaide Hospital Adelaide Australia Westmead Hospital Westmead Australia Centro de Oncologia e Radioterapia (COR) Mãe de Deus Porto Alegre Brazil Dr. H. Bliss Murphy Cancer Centre QEII Health Sciences Centre Capital District Health Authority Chi Mei Foundation Hospital, Liouying, Department of Internal Medicine, Division of Hema-Oncology St. John's Halifax Tainan Canada Canada Taiwan 5 5 5 5 5 5 Prince of Wales Hospital Randwick Australia PI Dr. Craig R. Lewis 4 Western Health Footscray Australia PI Dr. Dishan Gunawardana 4 5 Cancer Centre of Southeastern Ontario at Kingston General Hospital Kingston Azienda USL di Piacenza, Ospedale Guglielmo Saliceto Dipartimento di Oncologia Medica ed Ematologia Piacenza U.O. di Oncologia Medica Azienda Ospedaliera G Rummo Benevento Damic-Fundación Rusculleda Oxion Hospital Dia Oncologia LTDA. - Oxion Medicina Oncológica BCCA - Abbotsford Centre Cattedra di Oncologia Medica Seconda Università di Napoli Cordoba Canada PI Dr. Richard W. Gregg SI Dr. Anna Tomiak SI Dr. Mihaela Mates PI Dr. Luigi Cavanna SI Dr. Maria Angela Palladino PI Dr. Bruno Daniele SI Dr. Emiddio Barletta PI Dr. Norma Pilnik SI Dr. Alejandra Ibero PI Dr. Charles Padua SI Dr. Bruno Gustavo Muzzi Carvalho e Carneiro PI Dr. Robert Davis Winston SI Dr. Anagha Gurjal SI Dr. Ann K. L. Tan PI Dr. Fortunato Ciardiello SI Dr. Floriana Morgillo PI Dr. Vincenzo Adamo SI Dr. Tindara Franchina Italy 4 Italy 4 Argentina 3 Belo Horizonte Brazil Abbotsford Napoli 4 Canada 3 3 Italy 3 Dipartimento di Patologia Umana Università degli Studi di Messina Messina & UOC di Oncologia Medica AOOR Papardo-Piemonte Italy Tri-Service General Hospital 3F Division of Hematology/Oncology Taipei Taiwan PI Dr. Ching-Liang Ho 3 Concord Repatriation General Hospital Concord Australia PI Dr. Janette Vardy 2 Nambour General Hospital Nambour Australia PI Dr. Geoffrey Hawson 2 Royal North Shore Hospital St. Leonards Australia PI A/Prof. Nick Pavlakis 2 PI Dr. Carlos Alexandre Sydow Cerny SI Dr. Danielle Cristina Ovigli Silva Lopes SI Dr. Letícia Maria N. de Carvalho PI Dr. Claudio Verusio ESHO - Empresa de Serviços Hospitalares Ltda. Ospedale Generale Provinciale di Saronno, Oncologia Medica Sao Paulo Saronno Brazil Italy 3 2 2 6 Centro di Riferimento Oncologico - CRO Aviano Italy PI Dr. Alessandra Bearz 2 Perpetual Succour Hospital Cebu City Philippines PI Dr. Jemela Anne Osorio-Sanchez 2 Ajou University Hospital GyeongGi-Do South Korea PI Dr. Jin-Hyuk Choi 2 Centro Médico San Roque San Miguel de Argentina Tucumán PI Dr. Carlos Medina 1 PI Dr. Z. Yasmin Alam Windsor Regional Cancer Centre Windsor SI Dr. Swati Kulkarni Canada 1 Dipartimento Oncologico di III livello U.O. di Oncologia Medica della Casa di Cura di Alta Specialità “La Maddalena” Palermo Italy PI Dr. Vittorio Gebbia 1 Ospedale Eugenio Morelli-Sondalo, Azienda Ospedaliera della Valtellina e della Valchiavenna Sondalo Italy PI Dr. Giuseppe Valmadre 1 Ospedale Santa Croce Fano Italy PI Dr. Rodolfo Mattioli 1 Hospital Nacional Luis N. Sáenz De La Policía Nacional De Perú Lima Perú PI Dr. Carlos Alberto Farfan Tello 1 PI Dr. K. Joseph Philip Clintell, Inc. Skokie USA SI Dr. Elyse Lambiase PI Dr. Sharon Yee PI Dr. Francesco Perrone SI Dr. Jane Bryce Shapiro, Stafford and Yee Arcadia USA Unità Sperimentazioni Cliniche, Istituto Nazionale Tumori "Fondazione G. Pascale" - IRCCS Napoli Italy 1 1 7 Appendix 2: Subset analysis for response rate Variable Dacomitinib Number of Response responders rate Placebo Number of Response responders Rate Total ECOG PS 0 or 1 2 or 3 Smoking Never Past/ present Best response to prior EGFR TKI PD other Weight loss <5% ≥5% 480 240 Ethnicity East Asian Other K-RAS Mutation WT Unknown EGFR Mutation WT Unknown 28/361 6/119 7.8% 5.0% 2/182 1/58 1.1% 1.7% 21/178 13/302 11.8% 4.3% 0/86 3/154 0% 1.9% 4/157 30/323 2.5% 9.3% 1/66 2/174 1.5% 1.1% 30/394 4/86 7.6% 4.7% 2/193 1/47 1.0% 2.1 11/141 23/339 7.8% 6.8% 0/70 3/170 0% 1.8% 0/57 20/220 14/203 0% 9.1% 6.9% 0/21 1/120 2/99 0% 0.8% 2.0% 13/114 10/235 11/131 11.4% 4.3% 8.4% 1/68 0/114 2/58 1.5% 0% 3.4% 8