Phase II Study of AZD9291 in Advanced Stage NSCLC With EGFR and T790M Mutations Detected in Plasma Ct-DNA
Status:
Unknown status
Trial end date:
2020-02-24
Target enrollment:
Participant gender:
Summary
Circulating tumor DNA (ctDNA) is a highly specific and effective biomarker for the detection
of EGFR mutation status. We hypothesise AZD9291 is efficacious in patients with EGFR
sensitizing mutations and T790M detected in plasma ctDNA.
This is a prospective, open label, multi-centre single arm phase II study assessing the
efficacy and safety of AZD9291 monotherapy in patients with stage IIIB or IV harboring
sensitising EGFR mutation (exon 19 deletions or exon 21 L858R substitution mutations) and
T790M who have progressed following prior treatment with an approved EGFR TKI. Approximately
106 subjects will be enrolled.
All patients must have documented radiological progression on EGFR-TKI treatment and on the
last treatment administered prior to enrolling in the study.