A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer
NCT ID: NCT05091567
Last Updated: 2025-12-29
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
660 participants
INTERVENTIONAL
2021-11-18
2026-08-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Atezolizumab+Lurbinectedin
Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles.
Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle in combination with lurbinectedin on Day 1 of each 21-day cycle.
Atezolizumab
Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle for 4 cycles in the induction phase. Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle in the maintenance phase.
Lurbinectedin
Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 of each 21-day cycle in the maintenance phase.
Carboplatin
Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.
Etoposide
Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.
Arm B: Atezolizumab
Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles.
Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle.
Atezolizumab
Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle for 4 cycles in the induction phase. Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle in the maintenance phase.
Carboplatin
Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.
Etoposide
Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.
Interventions
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Atezolizumab
Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle for 4 cycles in the induction phase. Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle in the maintenance phase.
Lurbinectedin
Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 of each 21-day cycle in the maintenance phase.
Carboplatin
Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.
Etoposide
Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No prior systemic therapy for ES-SCLC
* Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
* Histologically or cytologically confirmed ES-SCLC
* Adequate hematologic and end-organ function to receive 4 cycles of induction treatment with carboplatin, etoposide and atezolizumab
* Measurable disease, as defined by RECIST v1.1
* Negative HIV test and no evidence of active Hepatitis B or Hepatitis C at screening
* ECOG PS of 0 or 1
* Ongoing response or stable disease per RECIST 1.1 after 4 cycles of induction therapy
* Toxicities attributed to prior induction anti-cancer therapy or PCI resolved to Grade \<=1
* Adequate hematologic and end-organ function
Exclusion Criteria
* Active or history of autoimmune disease or deficiency
* History of malignancies other than SCLC within 5 years prior to enrollment
* 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
* 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
* Treatment with investigational therapy within 28 days prior to enrollment
* Presence or history of CNS metastases
* Receiving consolidative chest radiation
* Severe infection within 2 weeks prior to randomization into the maintenance
* Treatment with therapeutic oral or IV antibiotics at the time of randomization
18 Years
ALL
No
Sponsors
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Jazz Pharmaceuticals
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
Marietta, Georgia, United States
Illinois Cancer Care
Peoria, Illinois, United States
New England Cancer Specialists
Scarborough, Maine, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
Mercy Research - St. Louis
St Louis, Missouri, United States
Clinical Research Alliance
Westbury, New York, United States
The Mark H. Zangmeister Ctr
Columbus, Ohio, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Hollings Cancer Center
Charleston, South Carolina, United States
Greco-Hainesworth Centers for Research
Chattanooga, Tennessee, United States
West Clinic
Germantown, Tennessee, United States
Sarah Cannon Research Institute / Tennessee Oncology
Nashville, Tennessee, United States
Institut Jules Bordet
Anderlecht, , Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
AZ St Maarten Campus Leopoldstr
Mechelen, , Belgium
CHU UCL Mont-Godinne
Mont-godinne, , Belgium
Vitaz
Sint-Niklaas, , Belgium
Zentralklinik Bad Berka GmbH
Bad Berka, , Germany
Evang. Lungenklinik Berlin Klinik für Pneumologie
Berlin, , Germany
Helios Klinikum Emil von Behring GmbH
Berlin, , Germany
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
KEM/Evang. Kliniken Essen Mitte gGmbH
Essen, , Germany
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
Georgsmarienhütte, , Germany
LungenClinic Großhansdorf GmbH
Großhansdorf, , Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH
Halle, , Germany
Fachklinik für Lungenerkrankungen
Immenhausen, , Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, , Germany
Asklepios Klinik Gauting
München-Gauting, , Germany
Sotiria Thoracic Diseases Hospital of Athens
Athens, , Greece
Errikos Dynan Hospital
Athens, , Greece
University Hospital of Larissa
Larissa, , Greece
Euromedical General Clinic of Thessaloniki
Thessaloniki, , Greece
Ag. Loukas Hospital
Thessaloniki, , Greece
Diavalkaniko Hospital
Thessaloniki, , Greece
Orszagos Koranyi Pulmonologiai Intezet
Budapest, , Hungary
Pécsi Tudományegyetem
Pécs, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
Szolnok, , Hungary
Tudogyogyintezet Torokbalint
Törökbálint, , Hungary
AUSL della Romagna
Ravenna, Emilia-Romagna, Italy
ASL 3 Genovese
Genoa, Liguria, Italy
Irccs Istituto Europeo di Oncologia (IEO)
Milan, Lombardy, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
Milan, Lombardy, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti
Torrette Di Ancona, The Marches, Italy
Health Pharma Professional Research
Mexico City, Mexico CITY (federal District), Mexico
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Morelia, , Mexico
Uniwersyteckie Centrum Kliniczne
Gda?sk, , Poland
Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II
Krakow, , Poland
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
Olsztyn, , Poland
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
Otwock, , Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
Poznan, , Poland
Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie
Warsaw, , Poland
Chungbuk National University Hospital
Cheongju-si, , South Korea
Chilgok Kyungpook National University Medical Center
Daegu, , South Korea
Samsung Changwon Hospital
Gyeongsangnam-do, , South Korea
Gyeongsang National University Hospital
Gyeongsangnam-do, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Ulsan University Hosiptal
Ulsan, , South Korea
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, LA Coruna, Spain
Hospital del Mar
Barcelona, , Spain
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
E-DA Hospital
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Adana Baskent University Hospital
Adana, , Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, , Turkey (Türkiye)
Liv Hospital Ankara
Ankara, , Turkey (Türkiye)
Ankara City Hospital
Ankara, , Turkey (Türkiye)
Uludag Uni Hospital
Bursa, , Turkey (Türkiye)
Pamukkale University School Of Medicine
Denizli, , Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne, , Turkey (Türkiye)
Ba?c?lar Medipol Mega Üniversite Hastanesi
Istanbul, , Turkey (Türkiye)
Istanbul Uni Cerrahpasa Medical Faculty Hospital
Istanbul, , Turkey (Türkiye)
Ac?badem Altunizade Hastanesi
Istanbul, , Turkey (Türkiye)
Izmir Medical Point Hospital
Izmir, , Turkey (Türkiye)
Kocaeli University Faculty of Medicine
İzmit, , Turkey (Türkiye)
Goztepe Prof.Dr. Suleyman Yalcin City Hospital
Kadiköy, , Turkey (Türkiye)
Medikal Park Samsun
Samsun, , Turkey (Türkiye)
TC Necmettin Erbakan University Meram Medical Faculty Hospital
Selçuklu, , Turkey (Türkiye)
Blackpool Victoria Hospital
Blackpool, , United Kingdom
Christie NHS Foundation Trust
GB Manchester, , United Kingdom
Castle Hill Hospital
Hull, , United Kingdom
St James University Hospital
Leeds, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Guy's Hospital
London, , United Kingdom
Countries
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References
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Paz-Ares L, Borghaei H, Liu SV, Peters S, Herbst RS, Stencel K, Majem M, Sendur MAN, Czyzewicz G, Caro RB, Lee KH, Johnson ML, Karadurmus N, Grohe C, Baka S, Csoszi T, Ahn JS, Califano R, Yang TY, Kemal Y, Ballinger M, Cuchelkar V, Graupner V, Lin YC, Chakrabarti D, Bhatt K, Cai G, Iannone R, Reck M; IMforte investigators. Efficacy and safety of first-line maintenance therapy with lurbinectedin plus atezolizumab in extensive-stage small-cell lung cancer (IMforte): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2025 Jun 14;405(10495):2129-2143. doi: 10.1016/S0140-6736(25)01011-6. Epub 2025 Jun 2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2023-503868-16-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
GO43104
Identifier Type: -
Identifier Source: org_study_id