Table 1. Overview of randomised phase III trials investigating first-line treatment of patients with epidermal growth factor receptor mutation-positive nonsmall cell lung cancer
CONSORT checklist entry [24]Study [ref.]
NEJ002 [12, 23]WJTOG3405 [13, 25]IPASS# [8, 14]EURTAC [9]LUX-Lung 3 [15]OPTIMAL [10, 11]LUX-Lung 6 [16, 26]ENSURE [17]
Publication statusFully published as primary manuscript; overall survival update published subsequentlyFully published as primary manuscript; updated overall survival published at ASCO 2012Fully published as primary manuscript; overall survival update published subsequentlyFully published as primary manuscriptFully published as primary manuscriptFully published as primary manuscript; overall survival update published at ASCO 2012Primary outcomes and quality of life data published at ASCO 2013Primary outcome published at WCLC 2013
Generic nameGefitinibGefitinibGefitinibErlotinibAfatinibErlotinibAfatinibErlotinib
Registration numberUMIN-CTR number C000000376UMIN-CTR number 000000539NCT00322452NCT00446225NCT00949650NCT00874419NCT01121393NCT01342965
Inclusion of protocol in the primary manuscriptNot attached to primary paperNot attached to primary paperAbbreviated CSR freely available onlineNot attached to primary paperRedacted trial protocol part of the primary paperPart of the primary paperCurrently only conference presentations availableCurrently only conference presentation available
Trial funding sourceJapan Society for Promotion of Science; Japanese Foundation for the Multidisciplinary Treatment of Cancer and Tokyo Cooperative Oncology Group (IIT)No sole study sponsor for this trial (IIT)AstraZenecaRoche (IIT)Boehringer IngelheimRoche (IIT)Boehringer IngelheimRoche

  • CONSORT: Consolidated Standards of Reporting Trials; WJTOG: West Japan Thoracic Oncology Group; NEJ002: North East Japan 002; IPASS: Iressa Pan-Asia Study; EURTAC: European Randomised Trial of Tarceva versus Chemotherapy; ASCO: American Society of Clinical Oncology; CSR: clinical study report; WCLC: World Conference on Lung Cancer; IIT: investigator-initiated trial #: all patients; : www.ClinicalTrials.gov unless otherwise stated.