The purpose of this study is to determine whether continuing erlotinib beyond disease progression in combination with chemotherapy is beneficial for NSCLC patients who have EGFR mutant disease or who have responded to EGFR TKI.
A Phase II randomised, multicenter study to assess the efficacy and safety of continuing erlotinib in addition to chemotherapy versus chemotherapy alone in patients who have EGFR mutant or EGFR TKI responsive NSCLC and have progressed on EGFR TKI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Helsinki University Hospital
Espoo, Finland
Helsinki University Hospital
Helsinki, Finland
Oulu University Hospital
Oulu, Finland
Pori Central Hospital
Pori, Finland
Progression-free survival of the whole study population and in the strata 1-2
Time frame: An expected average of 36 weeks after last subject enrolled into our study
Overall Survival
Time frame: An expected average of 52 weeks after last subject enrolled into our study
Overall Response Rate
Time frame: An expected average of 36 weeks after last subject enrolled into our study
Rate of non-progression at 9 and 18 weeks
Time frame: 18 weeks after date of randomization of a last patient
Safety and toxicity
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: An expected average of 52 weeks after last subject enrolled into our study
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Tampere University Hospital
Tampere, Finland
Turku University Hopital
Turku, Finland
Vaasa Central Hospital
Vaasa, Finland