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
Who is this study for? Patients with Extensive Stage Small Cell Lung Cancer
What treatments are being studied? [177Lu]Lu-DOTA-TATE+Tislelizumab+[68Ga]Ga-DOTA-TATE+Carboplatin+Etoposide
Status: Recruiting
Location: See all (44) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• Participant is \>= 18 years on the day of signing informed consent form
• Histologically or cytologically confirmed ES-SCLC
• Presence of measurable disease
• No prior systemic treatment for ES-SCLC (except the first cycle of chemotherapy with or without atezolizumab of the induction period
• ECOG status =\< 1
• Provision of tumor tissue to support exploratory biomarker analysis
• Life expectancy of \>= 6 months
Locations
United States
Washington, D.c.
Georgetown University Lombardi Cancer Center
RECRUITING
Washington D.c.
Florida
Advent Health Cancer Institute
RECRUITING
Orlando
Georgia
University Cancer and Blood Center LLC
RECRUITING
Athens
Kentucky
University of Kentucky
RECRUITING
Lexington
Missouri
St. Louis University
RECRUITING
St Louis
New Jersey
Hackensack Meridian Health
RECRUITING
Edison
Ohio
University Hospitals Of Cleveland
RECRUITING
Cleveland
Pennsylvania
Fox Chase Cancer Center
RECRUITING
Philadelphia
Other Locations
Austria
Novartis Investigative Site
RECRUITING
Innsbruck
Novartis Investigative Site
RECRUITING
Linz
Novartis Investigative Site
RECRUITING
Vienna
Canada
Novartis Investigative Site
RECRUITING
Montreal
Novartis Investigative Site
RECRUITING
Montreal
Novartis Investigative Site
RECRUITING
Toronto
China
Novartis Investigative Site
RECRUITING
Beijing
France
Novartis Investigative Site
RECRUITING
Bron
Novartis Investigative Site
RECRUITING
Lille
Novartis Investigative Site
RECRUITING
Marseille
Novartis Investigative Site
RECRUITING
Montpellier
Novartis Investigative Site
RECRUITING
Villejuif
Germany
Novartis Investigative Site
RECRUITING
Cologne
Novartis Investigative Site
RECRUITING
Essen
Hong Kong Special Administrative Region
Novartis Investigative Site
RECRUITING
Hong Kong
Israel
Novartis Investigative Site
RECRUITING
Beersheba
Novartis Investigative Site
RECRUITING
Haifa
Novartis Investigative Site
RECRUITING
Ramat Gan
Novartis Investigative Site
RECRUITING
Tel Aviv
Italy
Novartis Investigative Site
RECRUITING
Milan
Novartis Investigative Site
RECRUITING
Napoli
Netherlands
Novartis Investigative Site
RECRUITING
Amersfoort
Novartis Investigative Site
RECRUITING
Utrecht
Republic of Korea
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Singapore
Novartis Investigative Site
RECRUITING
Singapore
Spain
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Málaga
Novartis Investigative Site
RECRUITING
Salamanca
Taiwan
Novartis Investigative Site
RECRUITING
Taichung
Novartis Investigative Site
RECRUITING
Taipei
Novartis Investigative Site
RECRUITING
Taoyuan District
United Kingdom
Novartis Investigative Site
RECRUITING
Guildford
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2022-07-13
Estimated Completion Date: 2029-03-23
Participants
Target number of participants: 200
Treatments
Experimental: Dose Level 1 (DL1)
Dose Level 1 (DL1): \[177Lu\]Lu-DOTA-TATE 100 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3, and atezolizumab 1200 mg in induction period, then \[177Lu\]Lu-DOTA-TATE 100 mCi plus atezolizumab 1200 mg in the maintenance period.
Experimental: Dose Level 2a (DL2a)
Dose Level 2a (DL2a): \[177Lu\]Lu-DOTA-TATE 150 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3 and atezolizumab 1200 mg in induction period, then \[177Lu\]Lu-DOTA-TATE 150 mCi plus atezolizumab 1200 mg in the maintenance period.
Experimental: Dose Level 2b (DL2b)
Dose Level 2b (DL2b): \[177Lu\]Lu-DOTA-TATE 150 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3 and atezolizumad 1200 mg in induction period, then \[177Lu\]Lu-DOTA-TATE 200 mCi plus atezolizumab 1200 in the maintenance period.
Experimental: Dose Level 3a (DL3a)
Dose Level 3a (DL3a): \[177Lu\]Lu-DOTA-TATE 200 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3, and atezolizumab 1200 mg in induction period, then \[177Lu\]Lu-DOTA-TATE 200 mCi plus atezolizumab 1200 mg in the maintenance period.
Experimental: Dose Level 3b (DL3b)
Dose Level 3b (DL3b): \[177Lu\]Lu-DOTA-TATE 200 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3, and atezolizumab 1200 mg in induction period, then \[177Lu\]Lu-DOTA-TATE 250 mCi plus atezolizumab 1200 mg in the maintenance period.
Experimental: Dose Level 4 (DL4)
Dose Level 4 (DL4): \[177Lu\]Lu-DOTA-TATE 250 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3 and atezolizumab 1200 mg in induction period, then \[177Lu\]Lu-DOTA-TATE 250 mCi plus atezolizumab 1200 mg in the maintenance period.
Experimental: Phase II Experimental arm
\[177Lu\]Lu-DOTA-TATE at recommended dose declared in phase I part in combination with carboplatin, etoposide and atezolizumab (experimental arm)
Other: Phase II Control arm
Carboplatin, etoposide and atezolizumab alone (control arm)
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals