STILE version 1.0
Research type
Research Study
Full title
Stereotactic body radiotherapy with immunotherapy in early stage non-small cell lung cancer: tolerability and lung effects
IRAS ID
223158
Contact name
Merina Ahmed
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Eudract number
2016-005187-34
Duration of Study in the UK
3 years, 6 months, 1 days
Research summary
Currently, no adjuvant systemic treatment is offered to patients treated with stereotactic body radiotherapy (SBRT) in early stage non small-cell lung cancer (NSCLC). In this more elderly population, overall survival and cancer-specific survival appear inferior with SBRT than with surgical wedge resection. Immunotherapy, with its more favourable toxicity profile compared to chemotherapy may provide a more attractive adjuvant treatment in this population.
This is a single arm, multi-centre, phase Ib/II open label study of nivolumab administered on completion of SBRT to patients with early stage NSCLC. Nivolumab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody that is specific for a receptor on human immune cells, PD-1. By blocking this receptor nivolumab can activate a T cell anti-tumour immune response. Nivolumab is a licenced, second-line treatment of advanced NSCLC.
The study will recruit 31 patients with histologically verified NSCLC deemed by a local MDT to have anatomical stage T1-3 (≤5cm) N0 M0 by means of CT and FDG-PET, amenable to radical treatment with SBRT and inoperable due to medical co-morbidity, being technically unresectable or patient declining surgery after offer of surgical assessment.
Patients will receive nivolumab at 240 mg q2w as in IV infusion over 30 minutes every 2 weeks to complete 1 year. The first nivolumab infusion will be given after the final fraction of SBRT (within 24 hours) Patients will receive a total of 54 Gy if delivered in 3 fractions or 55 Gy if delivered in 5 fractions. Patients will be followed up for 2 years from the end of their SBRT.
The primary objective is to assess the lung toxicity associated with treatment. The secondary objectives are to assess the overall safety and to assess disease relapse rates and overall survival.
The study is sponsored by Royal Marsden NHS Foundation trust and the funding for the study is provided by Bristol-Myers Squibb.
REC name
London - Riverside Research Ethics Committee
REC reference
17/LO/1301
Date of REC Opinion
17 Aug 2017
REC opinion
Favourable Opinion