SBRT With Immunotherapy in Early Stage Non-small Cell Lung Cancer: Tolerability and Lung Effects (NCT03383302) | Clinical Trial Compass
CompletedPhase 1/2
SBRT With Immunotherapy in Early Stage Non-small Cell Lung Cancer: Tolerability and Lung Effects
United Kingdom36 participantsStarted 2018-02-08
Plain-language 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 for peripheral disease or 8 fractions in central disease. 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 for a further 13 cycles followed by Nivolumab 480mg Q4W for 7 cycles until 20 cycles in total are complete, unless any study drug discontinuation criteria are met. Treatment (20 cycles) will take a minimum of 1 year to complete but may exceed this timeframe if treatment delays are encountered.
(Patients who have enrolled on Nivolumab Q2W 240mg regimen for 26 cycles and are beyond cycle 14 will receive 26 cycles Q2W in total to complete treatment).
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. . Female CrCl= \[(140- age in years) X weight in kg X 0.85) ÷ (72 X serum creatinine in mg/ dL)\]
. . Male CrCl= \[(140- age in years) X weight in kg X 1.00) ÷ (72 X serum creatinine in mg/ dL)\] vi) AST ≤ 3 X ULN vii) ALT ≤ 3 X ULN viii) Total bilirubin ≤ 1.5 X ULN (except subjects with Gilbert Syndrome, who must have total bilirubin \< 50 μmol/L)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combined SBRT radiation with an immunotherapy drug called nivolumab for early-stage non-small cell lung cancer, and it specifically measured lung inflammation — called pneumonitis — as its main safety concern. Given that I have early-stage NSCLC, how worried should I be about that risk, and how does it compare to what's known from this completed trial?
2Since this was a Phase 1/2 trial, the main goal was still figuring out whether the combination is safe and tolerable — not yet proving it works better than standard treatment. Does the data from this trial give us enough confidence about both safety and effectiveness to consider this approach for my situation, or is the evidence still limited?
3SBRT is already used as a standard treatment for early-stage lung cancer in patients who can't have surgery. Would standard SBRT alone, or surgery if I'm eligible, be a more proven option for me right now compared to this combination approach that was still being studied?
4Because this trial has completed, would the doctors who ran it have published results I could look at, and is there any way you could walk me through what those results showed about how patients like me actually did?
5The trial studied both Stage I and Stage II non-small cell lung cancer — does the stage of my specific diagnosis affect how relevant this trial's findings are to my case, and whether my oncologist would even consider this treatment combination?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of Lung Toxicity (Pneumonitis) From Treatment With Nivolumab After SBRT for Early Stage NSCLC
Timeframe: Six months from final dose of SBRT (2-3 weeks) administered for each patient