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Keep this study
Lead
Finnish Lung Cancer Group
With
Roche Pharma AG
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed stage IIIB/IV NSCLC.
Investigator confirmed progression according RECIST 1.1 during EGFR TKI treatment within 28 days of the randomization
Activating mutation (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q) in the EGFR gene or have had at least partial response with EGFR TKI lasting ≥ 6 months
Performance status: WHO 0-2
Measurable disease according to RECIST 1.1
Patients must be able to comply with study treatments
Women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study