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
Sites (44)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Active, not recruiting |
| Kepler Universitaetsklinikum GmbH Coordinator of this site? Confirm its status | Linz | Austria | Active, not recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Active, not recruiting |
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Completed |
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Completed |
| - Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| - Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| University Hospital Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Completed |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Completed |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Active, not recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Active, not recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Institut Regional Du Cancer De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Active, not recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Active, not recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Guildford | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Meander Medisch Centrum Coordinator of this site? Confirm its status | Amersfoort | Netherlands | Completed |
| St Antonius Ziekenhuis Coordinator of this site? Confirm its status | Utrecht | Netherlands | Completed |
| - Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| University Cancer And Blood Center LLC Coordinator of this site? Confirm its status | Athens | United States | Unknown status |
| University Hospitals Of Cleveland Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Hackensack University Medical Ctr Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| AdventHealth Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Fox Chase Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| St Louis University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.