Version: 1.0.0 | Published: 28 Aug 2026 | Updated: 15 days ago
Documentation
Associated Media:
Description:
Study designed to meet need in patients treated with stereotactic body radiotherapy (SBRT) in early stage non small-cell lung cancer (NSCLC), for whom adjuvant systemic treatment is not usually offered. This is generally a more elderly population for whom surgery or chemotherapy is not deemed appropriate/desirable.
Immunotherapy, with its more favourable toxicity profile may provide a more attractive adjuvant treatment in this population.
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.
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 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.
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.
Coverage
Spatial:
United Kingdom
Typical Age Range:
18-150
Follow Up:
Other
Pathway:
Participants recruited through screening of NSCLC patients unsuitable or
unwilling to have surgery. SBRT delivered in either 3 or 5 fractions for
peripheral disease or 8 fractions in central disease. Participants received a
total of 54 Gy if delivered in 3 fractions or 55 Gy if delivered in 5 fractions.
Participants received first nivolumab infusion within 24 hours after the final
fraction of SBRT - thereafter 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 completed, unless any study drug discontinuation criteria met.
Assessment of toxicities performed at each clinic visit during treatment, and at
30 days and 100 days after the final nivolumab infusion. Changes in spirometry
values and PFTs assessed throughout the trial. Follow up of 2 years from the end
of SBRT; including Health-related quality of life (HRQoL) score, using EORTC
Quality of Life Questionnaire (QLQ-C30) version 3, at screening, and 3, 6, 9,
12, 18, 24 months post-SBRT IDMC performed safety review when first 5 patients
recruited and again when they reached 3Months follow-up. Recruitment continued
as planned and completed with 33 participants.
Provenance
Origin
Purposes:
Study
Sources:
Other
Collection Situations:
Cohort, study, trial
Temporal
Accrual Periodicity:
Static
Start Date:
17 January 2018
End Date:
26 June 2025
Time Lag:
Not applicable
Accessibility
Access
Access Rights:
in progress
Access Service:
Although not required, there is an option to use The Royal Marsden’s Trusted
Research Environment and informatics platform: BRIDgE (Biomedical Research
Informatics Digital Environment). BRIDgE is managed by The Royal Marsden’s
Information Team with support by the NIHR Biomedical Research Centre at The
Royal Marsden and ICR. The aim of the platform is to transform clinical practice
and improve outcomes for patients by enabling researchers to access real-world
cancer data within secure, collaborative, cloud-based workspaces. Learn more by
visiting the BRIDgE site within the NIHR BRC area of The Royal Marsden and ICR
website: https://www.cancerbrc.org/BRIDgE
Access Request Cost:
Depends on type of access. Costing available on application.
Delivery Lead Time:
Variable
Jurisdictions:
UK
Data Controller:
Royal Marsden NHS Foundation Trust
Data Processor:
Royal Marsden NHS Foundation Trust
Usage
Data Use Limitations:
Research-specific restrictions
Data Use Requirements:
- Ethics approval required
- Institution-specific restrictions
- Not for profit use
- User-specific restriction
Resource Creators:
The Royal Marsden NHS Foundation Trust;
The Royal Marsden Cancer Charity;
NIHR Biomedical Research Centre at The Royal Marsden and the ICR;
Bristol-Myers Squibb
Format and Standards
Vocabulary Encoding Schemes:
LOCAL
Conforms To:
LOCAL
Languages:
en
Observations
Statistical Population
Population Description
Population Size
Measured Property
Observation Date
Persons
Patients recruited from multiple sites over several years. Observation date given is last recruitment date.
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01 February 2024