A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab
NCT ID: NCT05142696
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
140 participants
INTERVENTIONAL
2022-07-13
2029-03-23
Brief Summary
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Detailed Description
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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 declaring 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).
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
[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
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.
[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
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.
[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
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.
[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
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.
[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
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.
[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
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)
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
Phase II Control arm
Carboplatin, etoposide and atezolizumab alone (control arm)
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
Interventions
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[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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Active autoimmune diseases or history of autoimmune diseases that may relapse
* Severe chronic or active infections (including active tuberculosis, HBV, or HCV infection) requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks before Cycle 1 Day 1
* Any major surgical procedure requiring general anesthesia =\< 28 days before Cycle 1 Day 1
* History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for participants participating in the study
* Known hypersensitivity to the active substances or any of the excipients of the study drugs
* Concurrent participation in another therapeutic clinical study
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
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Linz, Upper Austria, Austria
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Vienna, , Austria
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Beijing, , China
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Shanghai, , China
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Olomouc, , Czechia
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Bron, , France
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Lille, , France
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Marseille, , France
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Montpellier, , France
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Nantes, , France
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Villejuif, , France
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Cologne, North Rhine-Westphalia, Germany
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Essen, , Germany
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Hong Kong, , Hong Kong
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Beersheba, , Israel
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Haifa, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Milan, MI, Italy
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Napoli, , Italy
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Amersfoort, , Netherlands
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Utrecht, , Netherlands
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Singapore, , Singapore
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Seoul, , South Korea
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Seoul, , South Korea
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Salamanca, Castille and León, Spain
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Barcelona, Catalonia, Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Taichung, Taiwan ROC, Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Guildford, Surrey, United Kingdom
Countries
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Other Identifiers
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2021-004155-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-513185-19-00
Identifier Type: OTHER
Identifier Source: secondary_id
CAAA601A42101
Identifier Type: -
Identifier Source: org_study_id
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