Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

November 20, 2017

Primary Completion Date

March 28, 2019

Study Completion Date

August 11, 2020

Conditions
Small Cell Lung CancerSmall Cell Lung Cancer Extensive Stage
Interventions
DRUG

Nivolumab

Nivolumab is administered intravenously

RADIATION

177Lu-DOTA0-Tyr3-Octreotate

"177Lu-DOTA0-Tyr3-Octreotate will be administered every 8 weeks. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab. Each dose is infused over 30 minutes. On the day of 177Lu-DOTA0-Tyr3-Octreotate infusion, an intravenous bolus of anti-emetics will be given (suggested options: ondansetron (8 mg), granisetron (3 mg), or tropisetron (5 mg)). Administration of 177Lu-DOTA0-Tyr3-Octreotate may be given one day earlier or delayed up to 1 week due to holidays, inclement weather, conflicts, or similar reasons.~Concurrent amino acids are given with each dose of 177Lu-DOTA0-Tyr3-Octreotate since co-infusion of amino acids leads to a significant reduction (47%) in the mean radiation dose to the kidneys. The amino acid solution and 177Lu-DOTA0-Tyr3-Octreotate are administered in parallel by peripheral vein infusion"

Trial Locations (2)

20007

Georgetown Lombardi Comprehensive Cancer Center, Washington D.C.

07601

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

Advanced Accelerator Applications

INDUSTRY

lead

Georgetown University

OTHER