This is a randomised, open-label, phase IIb trial of afatinib to compare to gefitinib in first-line treatment setting with patients who are having epidermal growth factor receptor mutation positive advanced adenocarcinoma of the lung.
Name: Afatinib
Description: afatinib once dailyType: Drugafatinib
Name: gefitinib
Description: Gefitinib once dailyType: Druggefitinib
Description: Progression-free survival (PFS) defined as the time from the date of randomisation to the date of disease progression, or to date of death if a patient died earlier. Disease progression was primarily evaluated by an independent central imaging review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
Measure: Progression-free Survival Time: From first drug administration until last drug administration, up to 1293 daysDescription: Time to Treatment Failure (TTF) which was the time from the date of randomisation to the date of i.e. permanent treatment discontinuation for any reason.
Measure: Time to Treatment Failure (TTF) Time: From first drug administration until last drug administration, up to 1293 daysDescription: Overall survival (OS) which was defined as the time from the date of randomisation to the date of death.
Measure: Overall Survival Time: From first drug administration until last drug administration, up to 1482 daysDescription: Objective response rate (ORR) which was defined as the number of participants with complete response (CR) or partial response (PR) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. divided by the total number of participants who received treatment. Per RECIST v1.1. for target lesions and assessed by CT-scan or Magnetic Resonance Imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions from baseline; Overall Response (OR) = CR + PR
Measure: Objective Response Rate Time: From first drug administration until last drug administration, up to 1293 daysDescription: Number of participants with objective response over time, cumulative number of participants is displayed. Time to objective response was defined as the time from randomisation to the first recorded objective response.
Measure: Time to Objective Response Time: From first drug administration until last drug administration, up to 1293 daysDescription: Duration of objective response defined as the time of first objective response to the time of progression or death, whichever occurred first (or date of censoring for progression free survival (PFS))
Measure: Duration of Objective Response Time: From first drug administration until last drug administration, up to 1293 daysDescription: Disease control which was defined as objective response (complete response or partial response) or stable disease (SD).
Measure: Disease Control Time: From first drug administration until last drug administration, up to 1293 daysDescription: Duration of disease control was measured from randomisation to the time of progressive disease (PD) or death, whichever occurred first (or date of censoring for progression free survival (PFS))
Measure: Duration of Disease Control Time: From first drug administration until last drug administration, up to 1293 daysDescription: Tumour shrinkage assessed by minimum sum of post-baseline target lesion diameters recorded after randomisation. A positive value shows a decrease in tumour size.
Measure: Tumour Shrinkage Time: From first drug administration until last drug administration, up to 1293 daysDescription: Health-related quality of life (HRQoL) measured using European Quality of life - 5 Dimensions (EQ-5D) score for United Kingdom (UK) and Belgium and European European Quality Visual Analogue Scale (EQ-VAS). EQ-5D utility scores range from 0 (worst health) to 1 (full health). EQ-VAS scores range from 0 (worst imaginable health state) to 100 (best imaginable health state). Results display the mean score up to 56 weeks.
Measure: Health-related Quality of Life Time: Every 8 weeks, up to 56 weeksAllocation: Randomized
Parallel Assignment
There is one SNP
2. Documented activating epidermal growth factor receptor mutation (Del19 and/or L858R) with tumour tissues. --- L858R ---