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

Active:	Yes
Cancer Type:	Lung Cancer	NCT ID:	NCT05142696
Trial Phases:	Phase I Phase II	Protocol IDs:	CAAA601A42101 (primary) NCI-2022-04397 2021-004155-16 2024-513185-19-00
Eligibility:	18 - 100 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Novartis Pharmaceuticals Corporation
NCI Full Details:	http://clinicaltrials.gov/show/NCT05142696

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.

Objectives

The study for each participant consists of a Screening period, a Treatment period that
includes an Induction treatment period and a Maintenance treatment period, and a
Follow-up period.

The study will consist of a Phase Ib dose escalation with concurrent backfill part and a
randomised controlled Phase II part.

During the screening period of up to 28 days before starting SCLC treatment, each
participant will be assessed for somatostatin receptor (SSTR) expression by
[68Ga]Ga-DOTA-TATE imaging PET/scan.

The dose escalation part in this study will be guided by the dose limiting toxicity (DLT)
rate observed during the DLT period. To achieve a more robust dataset and to aid dose
decisions, additional participants may be backfilled in each dose level.

Upon dedclaring RD, a 1:1 randomised Phase II with approximately 140 participants with
newly diagnosed ES-SCLC will be enrolled and receive either [177Lu]Lu-DOTA-TATE at the RD
in combination with carboplatin, etoposide and atezolizumab (experimental arm) or
carboplatin, etoposide and atezolizumab alone (control arm).

Treatment Sites in Georgia

University Cancer and Blood Center, LLC - Athens Medical Oncology
3320 Old Jefferson Road
Building 800
Athens, GA 30607
www.universitycancer.com

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.