Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-20-118
Prinicipal Investigator
Machtay, Mitchell
Phase
Phase II/III
Age Group
Adult
Scope
National
Secondary Protocol No.
NRG-LU007
Title
NRG-LU007 Randomized Phase II/III Trial Of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR trial
Objective
Primary Objective
Phase II:
To compare investigator-assessed progression free survival (PFS) between atezolizumab plus radiotherapy and atezolizumab alone

Phase III:
To compare overall survival (OS) between atezolizumab plus radiotherapy and atezolizumab alone

Secondary Objectives
To assess the toxicity between the atezolizumab plus radiotherapy arm and the atezolizumab arm
To assess the impact of adding radiotherapy on PFS and OS in patients with 1-3 visible tumors and >3 visible tumors
To assess the impact of adding radiotherapy on PFS and OS in patients receiving consolidation radiotherapy to all visible disease ( complete consolidation ) and patients who do not receive consolidation radiation to all visible disease ( incomplete consolidation )

Exploratory Objectives
To assess the association between pre-treatment tumor burden (determined by central radiographic assessment, using both tumor number and tumor volume), and PFS and OS benefit
Applicable Disease Sites
Other
Status
Open
Participating Institutions
Hershey Medical Center