NCT05091567Active, not recruitingPhase 3
A study of lurbinectedin in combination with atezolizumab compared with atezolizumab as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) following first-line induction therapy with carboplatin, etoposide and atezolizumab
A Phase III, Randomized, Open-Label, Multicenter Study of Lurbinectedin in Combination with Atezolizumab Compared with Atezolizumab as Maintenance Therapy in Participants with Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following First-Line Induction Therapy with Carboplatin, Etoposide and Atezolizumab
Source: EU CTIS (euclinicaltrials.eu) · Last updated 30 Jul 2026
Brief summary (registry, in English)
To evaluate the efficacy of maintenance treatment with lurbinectedin in combination with atezolizumab compared with atezolizumab based on Independent Review Facility (IRF)-assessed progression-free survival (PFS) and overall survival (OS)
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 332 (estimated)
- First submitted
- 31 May 2024
- Start date
- 14 Feb 2022
- Lead sponsor
- F. Hoffmann-La Roche AG
- Diseases
- Lung cancer
- EU CT number
- 2023-503868-16-00
- EudraCT number
- 2021-001930-20
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 332
- 43 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned consolidative chest radiation
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, or lurbinectedin or trabectedin
Other illness
- Presence or history of CNS metastases
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- Disease progression following induction treatment
Other
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures
Who the study is looking for
- Histologically or cytologically confirmed ES-SCLC (per the VALG staging system)
- Adequate hematologic and end-organ function
- ECOG PS 0 or 1
- No prior systemic treatment for ES-SCLC
- Ongoing response or stable disease per RECIST v1.1 after completion of the induction therapy
- Toxicities attributed to prior induction anti-cancer therapy or PCI resolved to Grade 1 or better
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (43)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Jules Bordet Coordinator of this site? Confirm its status | Anderlecht | Belgium | Completed |
| JESSA Ziekenhuis Coordinator of this site? Confirm its status | Hasselt | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| A.Z. Sint-Maarten Coordinator of this site? Confirm its status | Mechelen | Belgium | Completed |
| Vitaz Coordinator of this site? Confirm its status | Sint-Niklaas | Belgium | Completed |
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Coordinator of this site? Confirm its status | Yvoir | Belgium | Completed |
| Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Helios Klinikum Emil von Behring GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Klinikum Chemnitz gGmbH Coordinator of this site? Confirm its status | Chemnitz | Germany | Active, not recruiting |
| KEM I Evang. Kliniken Essen-Mitte gGmbH Coordinator of this site? Confirm its status | Essen | Germany | Active, not recruiting |
| Asklepios Klinik Gauting GmbH Coordinator of this site? Confirm its status | Gauting | Germany | Active, not recruiting |
| LungenClinic Grosshansdorf GmbH Coordinator of this site? Confirm its status | Grosshansdorf | Germany | Active, not recruiting |
| Martha-Maria Krankenhaus Halle-Doelau gGmbH Coordinator of this site? Confirm its status | Halle (saale) | Germany | Active, not recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Luebeck | Germany | Active, not recruiting |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Active, not recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Henry Dunant Hospital Center Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| Thoracic General Hospital of Athens "I Sotiria" Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| General University Hospital of Larissa Coordinator of this site? Confirm its status | Larissa | Greece | Active, not recruiting |
| Athens Medical Center S.A. Coordinator of this site? Confirm its status | Thessaloniki | Greece | Active, not recruiting |
| St. Luke's Hospital S.A. Coordinator of this site? Confirm its status | Thessaloniki | Greece | Active, not recruiting |
| Orszagos Koranyi Pulmonologiai Intezet Coordinator of this site? Confirm its status | Budapest XII | Hungary | Active, not recruiting |
| University of Pecs Coordinator of this site? Confirm its status | Pécs | Hungary | Active, not recruiting |
| Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointézet Coordinator of this site? Confirm its status | Szolnok | Hungary | Active, not recruiting |
| Református Pulmonológiai Centrum Coordinator of this site? Confirm its status | Törökbálint | Hungary | Active, not recruiting |
| Azienda Unita Sanitaria Locale Della Romagna Coordinator of this site? Confirm its status | Faenza | Italy | Completed |
| Azienda Ospedaliero Universitaria Ospedali Riuniti Coordinator of this site? Confirm its status | Foggia | Italy | Completed |
| Azienda Sociosanitaria 3 Coordinator of this site? Confirm its status | Genoa | Italy | Completed |
| Azienda Unita Sanitaria Locale Della Romagna Coordinator of this site? Confirm its status | Lugo | Italy | Completed |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Istituto Europeo di Oncologia s.r.l Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Azienda Unità Sanitaria Locale della Romagna Coordinator of this site? Confirm its status | Ravenna | Italy | Completed |
| Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie Coordinator of this site? Confirm its status | Olsztyn | Poland | Active, not recruiting |
| Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy Coordinator of this site? Confirm its status | Otwock | Poland | Active, not recruiting |
| Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.