IMRT 2018

Nivolumab: RTOG 3505

A phase III, double-blind trial of cisplatin and etoposide plus thoracic radiation therapy followed by nivolumab or placebo for locally advanced NSCLC

Start Date: June 2016 Estimated Primary Completion Date: October 2022 Status: Not yet open for recruitment Sponsor: RTOG Foundation, Inc CT scan with IV contrast of lung and upper abdomen and MRI of brain with contrast within 60 days prior to enrollment ▪ Whole body FDG-PET within 60 days prior to registration ▪ Zubrod PS 0-1 ▪ Archived tumor block or punches available for PD-L1 analysis Key Inclusion Criteria ▪ Unresectable, inoperable Stage IIIA or IIIB NSCLC (or patients who refuse surgery) ▪

N=660

Thoracic RT + Cisplatin + Etoposide

Nivoluma b Q2W

Continue for 1 year

R

Thoracic RT + Cisplatin + Etoposide

Placebo Q2W

Primary Endpoints: OS, PFS Secondary Endpoints: None provided

Abbreviations and references can be found in the speaker notes. AEs = adverse events; BSC = best supportive care; DFS = disease-free survival; ECOG = Eastern Cooperative Oncology Group; HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human immunodeficiency virus; MLND = mediastinal lymph node dissection; NSCLC = non-small cell lung cancer; OS = overall survival; PD-L1 = programmed death-ligand 1; PK = pharmacokinetics; PS = performance status; R = randomized; Q3W = once every 3 weeks.

1. Clinicaltrials.gov. NCT02486718. Accessed July 27, 2016.