A Randomised Phase II Trial of Olaparib Maintenance Versus Placebo Monotherapy in Patients With Chemosensitive Advanced Non-Small Cell Lung Cancer
This is a multicentre randomised phase II trial. Patients are initially registered either
before or during induction chemotherapy, their response to which will be used to determine
whether they are eligible for randomisation. All patients will be asked to consent to
archival tissue collection for translational analysis and to provide a translational blood
sample. The second consent will precede randomisation to one of two groups of maintenance
therapy (olaparib or placebo) with 1:1 randomisation if they have had an objectively
measured complete or partial response following standard chemotherapy.
Randomised patients will receive olaparib or placebo until disease progression. They will be
monitored by CT scan every two cycles until disease progression, where they will be managed
according to local practice. Follow up will be for a maximum of 12 months from the point of
randomisation or until disease progression.
All randomised patients for whom we have a baseline translational blood sample will be asked
to provide a follow up blood sample upon randomisation and again at radiological
progression. Registered patients with progressive disease after the initial induction
chemotherapy will be asked to provide a follow-up blood sample at the end of induction
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
To establish the anti-tumour activity of Olaparib (measured by progression free survival),we will document the time from randomisation to any disease progression and/or death, defined according to strict RECIST (Response Evaluation Criteria in Solid Tumours) v1.1. Lesions will be compared to baseline measurements to assess progression.
Dean Fennell, Professor
University of Leicester
United Kingdom: Medicines and Healthcare Products Regulatory Agency