Lung Cancer Clinical Trial

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

Summary

Study GO43104 is a Phase III, randomized, open-label, multicenter study of lurbinectedin in combination with atezolizumab compared with atezolizumab alone administered as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and atezolizumab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and atezolizumab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will be randomized in a 1:1 ratio to receive either lurbinectedin plus atezolizumab or atezolizumab in the maintenance phase.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria for the Induction Phase:

ECOG PS of 0 or 1
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

Exclusion Criteria for the Induction Phase:

Presence or history of CNS metastases
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

Inclusion Criteria for the Maintenance Phase:

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 for the Maintenance Phase:

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

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

690

Study ID:

NCT05091567

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 99 Locations for this study

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Alabama Oncology
Birmingham Alabama, 35205, United States
Va Palo Alto Health Care System
Palo Alto California, 94304, United States
National Jewish Health
Denver Colorado, 80206, United States
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
Marietta Georgia, 30060, United States
Illinois Cancer Care
Peoria Illinois, 61615, United States
Hematology Oncology Clinic
Baton Rouge Louisiana, 70809, United States
New England Cancer Specialists
Scarborough Maine, 04074, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Cancer & Hematology Centers of Western Michigan; Spectrum Health Butterworth Research Pharmacy
Grand Rapids Michigan, 49503, United States
Mercy Research - St. Louis
Saint Louis Missouri, 63141, United States
Mercy Research SPRG
Springfield Missouri, 65804, United States
Optum Health Care
Las Vegas Nevada, 89102, United States
Clinical Research Alliance
Westbury New York, 11590, United States
The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.
Columbus Ohio, 43219, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Tennessee Oncology - Chattanooga; Tennessee Oncology - East Third Street
Chattanooga Tennessee, 37404, United States
West Clinic
Germantown Tennessee, 38138, United States
Tennessee Oncology; Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Michael E. DeBakey VA Medical Center
Houston Texas, 77030, United States
Institut Jules Bordet
Anderlecht , 1070, Belgium
UZ Leuven Gasthuisberg
Leuven , 3000, Belgium
CHU UCL Mont-Godinne
Mont-godinne , 5530, Belgium
Evang. Lungenklinik Berlin Klinik für Pneumologie
Berlin , 13125, Germany
Helios Klinikum Emil von Behring GmbH
Berlin , 14165, Germany
Klinikum Chemnitz gGmbH
Chemnitz , 09116, Germany
Kliniken Essen Mitte Evang. Huyssens Stiftung/Knappschaft GmbH
Essen , 45136, Germany
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
Georgsmarienhütte , 49124, Germany
LungenClinic Großhansdorf GmbH
Großhansdorf , 22927, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
Halle , 06120, Germany
KRH Klinikum Siloah-Oststadt-Heidehaus
Hannover , 30459, Germany
Fachklinik für Lungenerkrankungen
Immenhausen , 34376, Germany
Universitätsklinikum Schleswig-Holstein; Campus Lübeck
Lübeck , 23538, Germany
Asklepios Klinik München-Gauting
München-Gauting , 82131, Germany
Sotiria Thoracic Diseases Hospital of Athens; 3rd University Pathology Clinic
Athens , 115 2, Greece
ERRIKOS DYNAN HOSPITAL; 4th ONCOLOGY CLINIC
Athens , 11526, Greece
University Hospital of Larissa;Department of Medical Oncology
Larissa , 411 1, Greece
Euromedical General Clinic of Thessaloniki; Oncology Department
Thessaloniki , 546 4, Greece
Diavalkaniko Hospital
Thessaloniki , 570 0, Greece
Orszagos Koranyi Pulmonologiai Intezet
Budapest , 1121, Hungary
Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
Pécs , 7623, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
Szolnok , 5000, Hungary
Tudogyogyintezet Torokbalint
Torokbalint , 2045, Hungary
AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia
Ravenna Emilia-Romagna, 48121, Italy
ASL 3 Genovese
Genova Liguria, 16125, Italy
Irccs Ospedale San Raffaele;Oncologia Medica
Milano Lombardia, 20132, Italy
Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia
Milano Lombardia, 20141, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti
Torrette Di Ancona Marche, 60126, Italy
Chungbuk National University Hospital
Cheongju-si , 28644, Korea, Republic of
Samsung Changwon Hospital
Gyeongsangnam-do , 51353, Korea, Republic of
Gyeongsang National University Hospital
Gyeongsangnam-do , 52727, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si , 13605, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Ulsan University Hosiptal
Ulsan , 44033, Korea, Republic of
Health Pharma Professional Research
Cdmx Mexico CITY (federal District), 03100, Mexico
Christus Muguerza Clinica Vidriera
Monterrey Nuevo LEON, 64570, Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca de Juárez Oaxaca, 68020, Mexico
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara , 44280, Mexico
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
Gdańsk , 80-21, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawła II; Oddział Onkologiczny
Kraków , 31-20, Poland
Warminsko-Mazurskie Centrum Chorób Płuc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
Olsztyn , 10-35, Poland
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy; Oddzial III Chorob Pluc
Otwock , 05-40, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu; Oddzial Onkologii Klinicznej
Poznan , 60-56, Poland
Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie; Klinika Nowotworow Pluca i Klatki Piersiowej
Warszawa , 02-78, Poland
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
A Coruña LA Coruña, 15006, Spain
Hospital del Mar; Servicio de Oncologia
Barcelona , 08003, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona , 08041, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid , 28041, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla , 41013, Spain
E-DA Hospital; Chest
Kaohsiung , 824, Taiwan
Taichung Veterans General Hospital; Dept of Internal Medicine
Taichung , 407, Taiwan
National Cheng Kung University Hospital; Oncology
Tainan , 00704, Taiwan
Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
Taipei , 112, Taiwan
Adana Baskent University Hospital; Medical Oncology
Adana , 01120, Turkey
Gülhane Eğitim Ve Araştırma Hastanesi
Ankara , 06010, Turkey
Memorial Ankara Hastanesi
Ankara , 06520, Turkey
Liv Hospital Ankara; Medical Oncology
Ankara , 06680, Turkey
Ankara City Hospital; Oncology
Ankara , 06800, Turkey
Uludag Uni Hospital; Oncology
Bursa , 16059, Turkey
Pamukkale University School Of Medicine; Oncology Department
Denizli , 20070, Turkey
Dicle University Faculty of Medicine
Diyarbakir , 21280, Turkey
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne , 22030, Turkey
Bağcılar Medipol Mega Üniversite Hastanesi; Oncology
Istanbul , 34214, Turkey
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
Istanbul , 34300, Turkey
İzmir Medical Park; Onkoloji
Izmır , 35575, Turkey
Kocaeli University Faculty of Medicine; Medical oncology
Izmit , 31380, Turkey
Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
Kadiköy , 34722, Turkey
TC Necmettin Erbakan University Meram Medical Faculty Hospital
Konya , 42080, Turkey
Medikal Park Samsun
Samsun , 55200, Turkey
Acıbadem Altunizade Hastanesi; Oncology
Üsküdar , 34662, Turkey
Ysbyty Gwynedd Hospital
Bangor , LL57 , United Kingdom
Blackpool Victoria Hospital
Blackpool , FY3 8, United Kingdom
Western General Hospital; Edinburgh Cancer Center
Edinburgh , EH4 2, United Kingdom
Christie NHS Foundation Trust
GB Manchester , M20 4, United Kingdom
Castle Hill Hospital; The Queen's Centre for Oncology & Haematology
Hull , HU16 , United Kingdom
St James University Hospital
Leeds , LS9 7, United Kingdom
Leicester Royal Infirmary
Leicester , LE1 5, United Kingdom
University College London Hospital
London , NW1 -, United Kingdom
Guy's Hospital; Oncology & Haematology Clinical Trials (OHCT) Unit. GI/Urology Research Office
London , SE1 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

690

Study ID:

NCT05091567

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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