drugset / Trial / NCT05142696

A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab

NCT05142696 ↗

Phase 1/2 Active not recruiting 55 enrolled Novartis Pharmaceuticals
RandomizedSequentialOpen-labelTreatment

Summary

This study aims to establish a safe and well tolerated dose of \[177Lu\]Lu-DOTA-TATE in combination with carboplatin, etoposide and atezolizumab in this setting and to assess preliminary efficacy of this combination treatment versus the combination of carboplatin, etoposide, and atezolizumab.The study will be essential to assess a new potential therapeutic option in participants with this aggressive cancer type.

Timeline

Start
2022-07-13
Primary completion
2028-03-07
Completion
2028-03-07

Drugs

EvaluationDrugModalityDoseRoute
Subject [177Lu]Lu-DOTA-TATE Other / unclassified 3700 mbq —
Subject [177Lu]Lu-DOTA-TATE Other / unclassified 5550 mbq —
Subject [177Lu]Lu-DOTA-TATE Other / unclassified 7400 mbq —
Subject [177Lu]Lu-DOTA-TATE Other / unclassified 9250 mbq —
Background Atezolizumab Monoclonal antibody 1200 mg —
Background [68Ga]Ga-DOTA-TATE Diagnostic / imaging agent 2 mbq/kg —