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A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab
Sponsor: Novartis Pharmaceuticals
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.
Official title: A Phase Ib/II Dose Finding Study Assessing Safety and Efficacy of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC) in Combination With Carboplatin, Etoposide, and Atezolizumab in Induction and With Atezolizumab in Maintenance Phase
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2022-07-13
Completion Date
2029-03-23
Last Updated
2026-03-17
Healthy Volunteers
No
Conditions
Interventions
[177Lu]Lu-DOTA-TATE
Solution for infusion of \[177Lu\]Lu-DOTA-TATE will be administered as follows: * 2 administrations during the induction period on either Day 3, 4 or 5 of Week 1 and on Week 7 Day 3 * 1 to 4 administrations during the maintenance period on Week 13 Day 1, Week 16 Day 1, Week 19 Day 1 and Week 22 Day 1, depending on the dose assessed
Atezolizumab
Atezolizumab 1200 mg on Day 1 from Cycle 2 every 3 weeks in induction and maintenance period
[68Ga]Ga-DOTA-TATE
2 MBq/kg of body weight (0.054 mCi/kg), with a minimum dose of 100 MBq (2.7 mCi) and maximum dose of 200 MBq (5.4 mCi)
Carboplatin
Four cycles of carboplatin AUC 5 on Day 1 every 3 weeks (Weeks 1, 4, 7 and 10) in induction period
Etoposide
Four cycles of etoposide 100 mg/m2 on Day 1-3, every 3 weeks (Weeks 1, 4, 7 and 10) in induction period
Locations (40)
Georgetown University Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Advent Health Cancer Institute
Orlando, Florida, United States
University Cancer and Blood Center LLC
Athens, Georgia, United States
University of Kentucky
Lexington, Kentucky, United States
St. Louis University
St Louis, Missouri, United States
Hackensack Meridian Health
Edison, New Jersey, United States
University Hospitals Of Cleveland
Cleveland, Ohio, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Ctr
Nashville, Tennessee, United States
Novartis Investigative Site
Innsbruck, Tyrol, Austria
Novartis Investigative Site
Linz, Upper Austria, Austria
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Shanghai, China
Novartis Investigative Site
Olomouc, Czechia
Novartis Investigative Site
Bron, France
Novartis Investigative Site
Lille, France
Novartis Investigative Site
Marseille, France
Novartis Investigative Site
Montpellier, France
Novartis Investigative Site
Nantes, France
Novartis Investigative Site
Villejuif, France
Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Hong Kong, Hong Kong
Novartis Investigative Site
Beersheba, Israel
Novartis Investigative Site
Haifa, Israel
Novartis Investigative Site
Ramat Gan, Israel
Novartis Investigative Site
Tel Aviv, Israel
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Naples, Italy
Novartis Investigative Site
Amersfoort, Netherlands
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Málaga, Spain
Novartis Investigative Site
Taoyuan District, Taiwan
Novartis Investigative Site
Guildford, Surrey, United Kingdom