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NCT05142696Active, not recruitingPhase 1/2

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

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

Source: ClinicalTrials.gov · Last updated 19 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
55 (actual)
First submitted
15 Nov 2021
Start date
13 Jul 2022
Primary completion date
7 Mar 2028
Lead sponsor
Novartis Pharmaceuticals
Diseases
Lung cancer
NCT number
NCT05142696
EU CT number
2024-513185-19-00
EudraCT number
2021-004155-16

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 55
  • From 13 Jul 2022 to the primary completion date, 7 Mar 2028
  • 44 sites in 15 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participant has received prior therapy with an antibody or drug against immune checkpoint pathways
  • 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
  • Concurrent participation in another therapeutic clinical study

Other illness

  • Active autoimmune diseases or history of autoimmune diseases that may relapse
  • Known hypersensitivity to the active substances or any of the excipients of the study drugs

Other

  • History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for participants participating in the study

Who the study is looking for

  • 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

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (44)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medizinische Universitaet Innsbruck
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InnsbruckAustriaActive, not recruiting
Kepler Universitaetsklinikum GmbH
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LinzAustriaActive, not recruiting
Medical University of Vienna
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ViennaAustriaActive, not recruiting
Universitair Ziekenhuis Antwerpen
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EdegemBelgiumCompleted
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumCompleted
-
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MontrealCanadaUnknown status
-
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BeijingChinaUnknown status
-
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ShanghaiChinaUnknown status
University Hospital Olomouc
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OlomoucCzechiaCompleted
University Hospital Cologne AöR
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CologneGermanyCompleted
Universitaetsklinikum Essen (AoR)
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EssenGermanyCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Clínico San Carlos
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MadridSpainActive, not recruiting
Hospital Universitario Regional de Málaga
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MálagaSpainActive, not recruiting
Hospital Universitario De Salamanca
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SalamancaSpainActive, not recruiting
Hospices Civils de Lyon
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BronFranceActive, not recruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceActive, not recruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceActive, not recruiting
Institut Regional Du Cancer De Montpellier
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Montpellier Cedex 5FranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceActive, not recruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceActive, not recruiting
Institut Gustave Roussy
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VillejuifFranceActive, not recruiting
-
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GuildfordUnited KingdomUnknown status
-
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BeershebaIsraelUnknown status
-
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Ramat GanIsraelUnknown status
-
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Tel AvivIsraelUnknown status
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyCompleted
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyCompleted
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyCompleted
-
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SeoulSouth KoreaUnknown status
Meander Medisch Centrum
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AmersfoortNetherlandsCompleted
St Antonius Ziekenhuis
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UtrechtNetherlandsCompleted
-
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SingaporeSingaporeUnknown status
University Cancer And Blood Center LLC
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AthensUnited StatesUnknown status
University Hospitals Of Cleveland
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ClevelandUnited StatesUnknown status
Hackensack University Medical Ctr
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HackensackUnited StatesUnknown status
University of Kentucky
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LexingtonUnited StatesUnknown status
AdventHealth
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OrlandoUnited StatesUnknown status
Fox Chase Cancer Center
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PhiladelphiaUnited StatesUnknown status
St Louis University
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St LouisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.