Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-22-026
Prinicipal Investigator
Miccio, Joseph

Rovito, Marc
Phase
Phase II/III
Age Group
Adult
Scope
National
Secondary Protocol No.
A082002
Title
A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy With or Without SBRT for PD-L1-Negative, Advanced Non-Small Cell Lung Cancer
Objective
Primary objective:
To assess if SBRT improves the progression free survival (PFS, phase II portion) and overall survival (OS, phase III portion) of advanced stage NSCLC patients with PD-L1 TPS <1% who receive immunotherapy with or without chemotherapy.

Secondary objectives:
To estimate and compare the rates of ≥ grade 3-4 and all grade adverse events by CTCAEv5.0 between the arms. To summarize and compare progression-free survival (PFS) per RECIST between the arms. To determine and compare the objective response rate (ORR) per RECIST between the arms (including at both irradiated and un-irradiated sites).
Applicable Disease Sites
Lung
Status
Open
Participating Institutions
Hershey Medical Center

St. Joseph Cancer Center