Fig. 1

Patient disposition. ^a For 1 patient (n = 1), this occurred after primary data cut of 21 March 2014. ^b For the BTH1677 arm, ‘Other’ included investigator decision (n = 2), patient ineligibility (n = 2), radiotherapy following response (n = 1), tumor necrosis (n = 1), and sponsor ended study (n = 1); For the Control arm, ‘Other’ included planned surgery (n = 2), administrative decision (n = 1), investigator decision (n = 1), and sponsor ended study (n = 1). ^c Final data lock for OS analysis (16 March 2016) was performed approximately 3 years after the randomization date of last patient enrolled into the study. ^d Reasons for exclusion from efficacy analyses related to central radiology review in the BTH1677 arm were no evaluable baseline and/or post-baseline CT scan (n = 10; none of these patients had a best response of disease progression ie, clinical progression, reported by the investigator), and additionally 1 patient did not have histologically-confirmed NSCLC; in the Control arm, the primary reason for exclusion was no evaluable post-baseline CT scan (n = 8; 2 of these patients had a best response of disease progression ie, clinical progression, reported by the investigator). ^e Per protocol, to be “response evaluable” patients with best response of stable disease had to exhibit this response for at least 42 days (6 weeks) post randomization – if last scan occurred prior to this they were not “response evaluable”. Two patients in the BTH1677 arm were not evaluable for objective response, as their only on-study scan showed stable disease < 6 weeks post randomization. Abbreviations: CT computed tomography, N overall sample size, n number of patients, NSCLC non-small cell lung cancer, OS overall survival