RTOG Foundation Study 3505

Study Date: January 23, 2019 | Status Terminated

Randomized, Double Blinded Phase III Trial of Cisplatin and Etoposide Plus Thoracic Radiation Therapy Followed By Nivolumab/Placebo For Locally Advanced Non-Small Cell Lung Cancer

Principal Investigator

David E. Gerber, MD

Primary Objective

To compare the overall survival (OS) for patients with Stage III unresectable non-small cell lung cancer treated with or without nivolumab following concurrent chemoradiation.

Patient Population

Patients with Stage IIIA or stage IIIB pathologically proven NSCLC with unresectable, medically inoperable disease, or patients who refuse resection.

Study Results

This study was terminated early due to the reporting of another study which changed this population's standard of care and rendered the control arm obsolete. Eight of the planned 550 analyzable participants were enrolled at the time of termination. No publication was generated for this study due to its early termination. Study results are posted on ClinicalTrials.gov.

Participating Sites

Institution NameCityState/Country
Case Western Reserve UniversityClevelandOH
Cleveland Clinic FoundationClevelandOH
Emory University/Winship Cancer CenterAtlantaGA
Greater Baltimore Medical CenterBaltimoreMD
Henry Ford HospitalDetroitMI
Inova Fairfax HospitalFalls ChurchVA
Nancy N. & J.C. Lewis Research and Cancer Pavilion @St. Joseph’s/CandlerSavannahGA
McGill University Department of OncologyMontrealQC
Memorial Sloan Kettering Cancer CenterNew YorkNY
Mercy Medical CenterBaltimoreMD
MetroHealth Medical CenterClevelandOH
Mount Sinai Medical CenterMiami BeachFL
Reading HospitalWest ReadingPA
Stanford Cancer InstitutePalo AltoCA
Toledo Cancer CenterToledoOH
UC San Diego Moores Cancer CenterLa JollaCA
University of FloridaGainesvilleFL
University of KentuckyLexingtonKY
University of RochesterRochesterNY
University of Wisconsin Hospital and ClinicsMadisonWI