SBRT With Immunotherapy in Early Stage Non-small Cell Lung Cancer: Tolerability and Lung Effects
Status:
Recruiting
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
Summary
This is a single arm, multi-centre, phase II open label study of nivolumab with stereotactic
body radiotherapy (SBRT) for early stage non-small cell lung cancer.
SBRT will be delivered in either 3 or 5 fractions. A flat dose of 240 mg nivolumab infusion
will begin after the final fraction of SBRT, within 24 hours and typically on the same day.
Nivolumab will subsequently be given every 2 weeks at a flat dose of 240 mg until 1 year of
total treatment unless any study drug discontinuation criteria are met.
Assessment of toxicities will be performed at each clinic visit during treatment, at 30 days
after the final nivolumab infusion and until 100 days after the final nivolumab infusion.
Changes in spirometry values and PFTs will be assessed throughout the trial.
Relapse rates will be assessed with staging CT scans at 3, 6, 12, 18 and 24 months post SBRT.
An exploratory assessment will be made of the effect pre-treatment pulmonary function tests
(PFTs) have on outcome measures.