SBRT With Immunotherapy in Early Stage Non-small Cell Lung Cancer: Tolerability and Lung Effects

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

February 8, 2018

Primary Completion Date

August 12, 2024

Study Completion Date

June 26, 2025

Conditions
Non-small Cell Lung Cancer Stage IINon-small Cell Lung Cancer Stage I
Interventions
RADIATION

Stereotactic body radiotherapy

Patients will receive a total of 54 Gy if delivered in 3 fractions, 55 Gy if delivered in 5 fractions or 60 Gy if delivered in 8 fractions.

DRUG

Nivolumab

Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody, that binds to the PD-1 receptor and blocks interaction with its ligands PD-L1 and PD-L2. Nivolumab will be administered intravenously at a flat dose of 240 mg q2w over 30 minutes for 13 cycles followed by 480mg q4w over 60 minutes for 7 cycles, until 20 cycles in total to complete (a minimum of 1 year of treatment if no delays are encountered).

Trial Locations (1)

SM2 5PT

Royal Marsden Hospital, Sutton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Royal Marsden NHS Foundation Trust

OTHER