The PRIMING study
Research type
Research Study
Full title
PembRolIzuMab and stereotactic body radiotherapy In metastatic Non-small-cell lunG cancer patients
IRAS ID
211803
Contact name
Fiona McDonald
Contact email
Sponsor organisation
Royal Marsden NHS Foundation Trust
Eudract number
2016-002962-30
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
This is a single centre non-randomised, open label, dose escalation phase 1 clinical trial of lung stereotactic body radiotherapy (SBRT) to part of a lung lesion in patients with advanced non-small cell lung cancer (NSCLC) in combination with pembrolizumab. This study will recruit up to 24 patients whose lung cancer has progressed beyond one line of palliative chemotherapy, and an EGFR or ALK inhibitor if an EGFR driver mutation or ALK gene rearrangement is present, respectively, and now requires further palliative systemic treatment.
The study will be conducted in two parts; an initial lung SBRT dose escalation phase (Part A) where the first dose level is 30Gy in 3# and the second is 54Gy in 3#, followed by a lung SBRT dose expansion cohort (Part B). The dose escalation phase is based on a 3+3 design such that patients will be treated in cohorts of 3-6 patients.
During the dose expansion cohort, 12 patients will have lung SBRT dosed at the RP2D determined during the dose escalation phase in combination with pembrolizumab to obtain additional safety and response data.
All patients in Part A and Part B will receive pembrolizumab dosed at 200 mg every 3 weeks, until disease progression, unacceptable toxicities, the patient withdraws consent from the trial, or the patient has completed 24 months of treatment.
REC name
London - Central Research Ethics Committee
REC reference
17/LO/1591
Date of REC Opinion
11 Jan 2018
REC opinion
Further Information Favourable Opinion