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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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (43)

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

SiteCityCountrySite status
Institut Jules Bordet
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AnderlechtBelgiumCompleted
JESSA Ziekenhuis
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HasseltBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
A.Z. Sint-Maarten
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MechelenBelgiumCompleted
Vitaz
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Sint-NiklaasBelgiumCompleted
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
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YvoirBelgiumCompleted
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
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BerlinGermanyActive, not recruiting
Helios Klinikum Emil von Behring GmbH
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BerlinGermanyActive, not recruiting
Klinikum Chemnitz gGmbH
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ChemnitzGermanyActive, not recruiting
KEM I Evang. Kliniken Essen-Mitte gGmbH
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EssenGermanyActive, not recruiting
Asklepios Klinik Gauting GmbH
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GautingGermanyActive, not recruiting
LungenClinic Grosshansdorf GmbH
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GrosshansdorfGermanyActive, not recruiting
Martha-Maria Krankenhaus Halle-Doelau gGmbH
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Halle (saale)GermanyActive, not recruiting
Universitaetsklinikum Schleswig-Holstein AöR
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LuebeckGermanyActive, not recruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainActive, not recruiting
Hospital del Mar
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BarcelonaSpainActive, not recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Henry Dunant Hospital Center
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AthensGreeceActive, not recruiting
Thoracic General Hospital of Athens "I Sotiria"
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AthensGreeceActive, not recruiting
General University Hospital of Larissa
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LarissaGreeceActive, not recruiting
Athens Medical Center S.A.
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ThessalonikiGreeceActive, not recruiting
St. Luke's Hospital S.A.
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ThessalonikiGreeceActive, not recruiting
Orszagos Koranyi Pulmonologiai Intezet
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Budapest XIIHungaryActive, not recruiting
University of Pecs
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PécsHungaryActive, not recruiting
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointézet
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SzolnokHungaryActive, not recruiting
Református Pulmonológiai Centrum
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TörökbálintHungaryActive, not recruiting
Azienda Unita Sanitaria Locale Della Romagna
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FaenzaItalyCompleted
Azienda Ospedaliero Universitaria Ospedali Riuniti
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FoggiaItalyCompleted
Azienda Sociosanitaria 3
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GenoaItalyCompleted
Azienda Unita Sanitaria Locale Della Romagna
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LugoItalyCompleted
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyCompleted
Istituto Europeo di Oncologia s.r.l
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MilanItalyCompleted
Azienda Unità Sanitaria Locale della Romagna
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RavennaItalyCompleted
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
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CracowPolandActive, not recruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandActive, not recruiting
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
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OlsztynPolandActive, not recruiting
Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy
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OtwockPolandActive, not recruiting
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow
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PoznanPolandActive, not recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandActive, not recruiting

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