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

Trial Title: 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

Condition: Small-Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Carboplatin
Etoposide
Atezolizumab

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Atezolizumab
Description: 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.
Arm group label: Arm A: Atezolizumab+Lurbinectedin
Arm group label: Arm B: Atezolizumab

Other name: Tecentriq, RO5541267

Intervention type: Drug
Intervention name: Lurbinectedin
Description: Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 of each 21-day cycle in the maintenance phase.
Arm group label: Arm A: Atezolizumab+Lurbinectedin

Other name: PM01183/JZP712

Intervention type: Drug
Intervention name: Carboplatin
Description: Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.
Arm group label: Arm A: Atezolizumab+Lurbinectedin
Arm group label: Arm B: Atezolizumab

Intervention type: Drug
Intervention name: Etoposide
Description: Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.
Arm group label: Arm A: Atezolizumab+Lurbinectedin
Arm group label: Arm B: Atezolizumab

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Florida Cancer Specialists - Fort Myers (Broadway)

Address:
City: Fort Myers
Zip: 33901
Country: United States

Facility:
Name: Florida Cancer Specialist, North Region

Address:
City: Saint Petersburg
Zip: 33705
Country: United States

Facility:
Name: SCRI Florida Cancer Specialists PAN

Address:
City: Tallahassee
Zip: 32308
Country: United States

Facility:
Name: Florida Cancer Specialists

Address:
City: West Palm Beach
Zip: 33401
Country: United States

Facility:
Name: Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

Address:
City: Marietta
Zip: 30060
Country: United States

Facility:
Name: Illinois Cancer Care

Address:
City: Peoria
Zip: 61615
Country: United States

Facility:
Name: Hematology Oncology Clinic

Address:
City: Baton Rouge
Zip: 70809
Country: United States

Facility:
Name: New England Cancer Specialists

Address:
City: Scarborough
Zip: 04074
Country: United States

Facility:
Name: Dana Farber Cancer Institute

Address:
City: Boston
Zip: 02215
Country: United States

Facility:
Name: Cancer & Hematology Centers of Western Michigan; Spectrum Health Butterworth Research Pharmacy

Address:
City: Grand Rapids
Zip: 49503
Country: United States

Facility:
Name: Mercy Research - St. Louis

Address:
City: Saint Louis
Zip: 63141
Country: United States

Facility:
Name: Mercy Research SPRG

Address:
City: Springfield
Zip: 65804
Country: United States

Facility:
Name: Clinical Research Alliance

Address:
City: Westbury
Zip: 11590
Country: United States

Facility:
Name: The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.

Address:
City: Columbus
Zip: 43219
Country: United States

Facility:
Name: Fox Chase Cancer Center

Address:
City: Philadelphia
Zip: 19111
Country: United States

Facility:
Name: Rhode Island Hospital

Address:
City: Providence
Zip: 02903
Country: United States

Facility:
Name: Hollings Cancer Center

Address:
City: Charleston
Zip: 29425
Country: United States

Facility:
Name: Greco-Hainesworth Centers for Research; ETN (East Tennessee)

Address:
City: Chattanooga
Zip: 37404
Country: United States

Facility:
Name: West Clinic

Address:
City: Germantown
Zip: 38138
Country: United States

Facility:
Name: Sarah Cannon Research Institute / Tennessee Oncology

Address:
City: Nashville
Zip: 37203
Country: United States

Facility:
Name: Institut Jules Bordet

Address:
City: Anderlecht
Zip: 1070
Country: Belgium

Facility:
Name: Jessa Zkh (Campus Virga Jesse)

Address:
City: Hasselt
Zip: 3500
Country: Belgium

Facility:
Name: UZ Leuven Gasthuisberg

Address:
City: Leuven
Zip: 3000
Country: Belgium

Facility:
Name: AZ St Maarten Campus Leopoldstr

Address:
City: Mechelen
Zip: 2800
Country: Belgium

Facility:
Name: CHU UCL Mont-Godinne

Address:
City: Mont-godinne
Zip: 5530
Country: Belgium

Facility:
Name: Vitaz

Address:
City: Sint Niklaas
Zip: 9100
Country: Belgium

Facility:
Name: Zentralklinik Bad Berka GmbH; Abteilung Onkologie und Hämatologie

Address:
City: Bad Berka
Zip: 99437
Country: Germany

Facility:
Name: Evang. Lungenklinik Berlin Klinik für Pneumologie

Address:
City: Berlin
Zip: 13125
Country: Germany

Facility:
Name: Helios Klinikum Emil von Behring GmbH

Address:
City: Berlin
Zip: 14165
Country: Germany

Facility:
Name: Klinikum Chemnitz gGmbH

Address:
City: Chemnitz
Zip: 09116
Country: Germany

Facility:
Name: KEM/Evang. Kliniken Essen Mitte gGmbH; Klinik für Internistische Onkologie / Hämatologie

Address:
City: Essen
Zip: 45136
Country: Germany

Facility:
Name: Asklepios Klinik Gauting; Onkologisches Studienzentrum

Address:
City: Gauting
Zip: 82131
Country: Germany

Facility:
Name: Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH

Address:
City: Georgsmarienhütte
Zip: 49124
Country: Germany

Facility:
Name: LungenClinic Großhansdorf GmbH; Klinische Forschung

Address:
City: Großhansdorf
Zip: 22927
Country: Germany

Facility:
Name: Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II

Address:
City: Halle
Zip: 06120
Country: Germany

Facility:
Name: KRH Klinikum Siloah-Oststadt-Heidehaus

Address:
City: Hannover
Zip: 30459
Country: Germany

Facility:
Name: Fachklinik für Lungenerkrankungen

Address:
City: Immenhausen
Zip: 34376
Country: Germany

Facility:
Name: Universitätsklinikum Schleswig-Holstein; Campus Lübeck

Address:
City: Lübeck
Zip: 23538
Country: Germany

Facility:
Name: Krankenhaus Barmherziger Brüder; Klinik für Internistische Onkologie / Hämatologie

Address:
City: Regensburg
Zip: 93049
Country: Germany

Facility:
Name: Sotiria Thoracic Diseases Hospital of Athens; 3rd University Pathology Clinic

Address:
City: Athens
Zip: 115 27
Country: Greece

Facility:
Name: ERRIKOS DYNAN HOSPITAL; 4th ONCOLOGY CLINIC

Address:
City: Athens
Zip: 11526
Country: Greece

Facility:
Name: University Hospital of Larissa;Department of Medical Oncology

Address:
City: Larissa
Zip: 411 10
Country: Greece

Facility:
Name: Euromedical General Clinic of Thessaloniki; Oncology Department

Address:
City: Thessaloniki
Zip: 546 45
Country: Greece

Facility:
Name: Diavalkaniko Hospital

Address:
City: Thessaloniki
Zip: 570 01
Country: Greece

Facility:
Name: Orszagos Koranyi Pulmonologiai Intezet

Address:
City: Budapest
Zip: 1121
Country: Hungary

Facility:
Name: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

Address:
City: Pécs
Zip: 7623
Country: Hungary

Facility:
Name: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.

Address:
City: Szolnok
Zip: 5000
Country: Hungary

Facility:
Name: Tudogyogyintezet Torokbalint

Address:
City: Torokbalint
Zip: 2045
Country: Hungary

Facility:
Name: AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia

Address:
City: Ravenna
Zip: 48121
Country: Italy

Facility:
Name: ASL 3 Genovese

Address:
City: Genova
Zip: 16125
Country: Italy

Facility:
Name: Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia

Address:
City: Milano
Zip: 20141
Country: Italy

Facility:
Name: Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda); Oncologico -Onc.Falck

Address:
City: Milano
Zip: 20162
Country: Italy

Facility:
Name: Azienda Ospedaliero Universitaria Ospedali Riuniti

Address:
City: Torrette Di Ancona
Zip: 60126
Country: Italy

Facility:
Name: Chungbuk National University Hospital

Address:
City: Cheongju-si
Zip: 28644
Country: Korea, Republic of

Facility:
Name: Chilgok Kyungpook National University Medical Center

Address:
City: Daegu
Zip: 702-210
Country: Korea, Republic of

Facility:
Name: Samsung Changwon Hospital

Address:
City: Gyeongsangnam-do
Zip: 51353
Country: Korea, Republic of

Facility:
Name: Gyeongsang National University Hospital

Address:
City: Gyeongsangnam-do
Zip: 52727
Country: Korea, Republic of

Facility:
Name: Seoul National University Bundang Hospital

Address:
City: Seongnam-si
Zip: 463-707
Country: Korea, Republic of

Facility:
Name: Asan Medical Center

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Facility:
Name: Samsung Medical Center

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Facility:
Name: Ulsan University Hosiptal

Address:
City: Ulsan
Zip: 44033
Country: Korea, Republic of

Facility:
Name: Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

Address:
City: Guadalajara
Zip: 44280
Country: Mexico

Facility:
Name: Health Pharma Professional Research

Address:
City: Cdmx
Zip: 03100
Country: Mexico

Facility:
Name: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

Address:
City: Gdansk
Zip: 80-214
Country: Poland

Facility:
Name: Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II; Oddzia? Onkologiczny

Address:
City: Kraków
Zip: 31-202
Country: Poland

Facility:
Name: Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii

Address:
City: Olsztyn
Zip: 10-357
Country: Poland

Facility:
Name: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy; Oddzial III Chorob Pluc

Address:
City: Otwock
Zip: 05-400
Country: Poland

Facility:
Name: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu; Oddzial Onkologii Klinicznej

Address:
City: Poznan
Zip: 60-569
Country: Poland

Facility:
Name: Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie; Klinika Nowotworow Pluca i Klatki Piersiowej

Address:
City: Warszawa
Zip: 02-781
Country: Poland

Facility:
Name: Hospital Univ Vall d'Hebron; Servicio de Oncologia

Address:
City: Sant Andreu de La Barca
Zip: 08740
Country: Spain

Facility:
Name: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

Address:
City: A Coruña
Zip: 15006
Country: Spain

Facility:
Name: Hospital del Mar; Servicio de Oncologia

Address:
City: Barcelona
Zip: 08003
Country: Spain

Facility:
Name: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

Address:
City: Barcelona
Zip: 08041
Country: Spain

Facility:
Name: Hospital Universitario 12 de Octubre; Servicio de Oncologia

Address:
City: Madrid
Zip: 28041
Country: Spain

Facility:
Name: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

Address:
City: Malaga
Zip: 29010
Country: Spain

Facility:
Name: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

Address:
City: Sevilla
Zip: 41013
Country: Spain

Facility:
Name: E-DA Hospital; Chest

Address:
City: Kaohsiung
Zip: 824
Country: Taiwan

Facility:
Name: Taichung Veterans General Hospital; Dept of Internal Medicine

Address:
City: Taichung
Zip: 407
Country: Taiwan

Facility:
Name: National Cheng Kung University Hospital; Oncology

Address:
City: Tainan
Zip: 00704
Country: Taiwan

Facility:
Name: Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology

Address:
City: Taipei
Zip: 112
Country: Taiwan

Facility:
Name: Adana Baskent University Hospital; Medical Oncology

Address:
City: Adana
Zip: 01120
Country: Turkey

Facility:
Name: Gülhane E?itim Ve Ara?t?rma Hastanesi

Address:
City: Ankara
Zip: 06010
Country: Turkey

Facility:
Name: Memorial Ankara Hastanesi

Address:
City: Ankara
Zip: 06520
Country: Turkey

Facility:
Name: Liv Hospital Ankara; Medical Oncology

Address:
City: Ankara
Zip: 06680
Country: Turkey

Facility:
Name: Ankara City Hospital; Oncology

Address:
City: Ankara
Zip: 06800
Country: Turkey

Facility:
Name: Uludag Uni Hospital; Oncology

Address:
City: Bursa
Zip: 16059
Country: Turkey

Facility:
Name: Pamukkale University School Of Medicine; Oncology Department

Address:
City: Denizli
Zip: 20070
Country: Turkey

Facility:
Name: Dicle University Faculty of Medicine

Address:
City: Diyarbakir
Zip: 21280
Country: Turkey

Facility:
Name: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

Address:
City: Edirne
Zip: 22030
Country: Turkey

Facility:
Name: Ba?c?lar Medipol Mega Üniversite Hastanesi; Oncology

Address:
City: Istanbul
Zip: 34214
Country: Turkey

Facility:
Name: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

Address:
City: Istanbul
Zip: 34300
Country: Turkey

Facility:
Name: ?zmir Medical Park; Onkoloji

Address:
City: Izmir
Country: Turkey

Facility:
Name: Kocaeli University Faculty of Medicine; Medical oncology

Address:
City: Izmit
Zip: 31380
Country: Turkey

Facility:
Name: Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology

Address:
City: Kadiköy
Zip: 34722
Country: Turkey

Facility:
Name: Medikal Park Samsun

Address:
City: Samsun
Zip: 55200
Country: Turkey

Facility:
Name: TC Necmettin Erbakan University Meram Medical Faculty Hospital

Address:
City: Selçuklu
Zip: 42080
Country: Turkey

Facility:
Name: Ac?badem Altunizade Hastanesi; Oncology

Address:
City: Üsküdar
Zip: 34662
Country: Turkey

Facility:
Name: Ysbyty Gwynedd Hospital

Address:
City: Bangor
Zip: LL57 2PW
Country: United Kingdom

Facility:
Name: Blackpool Victoria Hospital

Address:
City: Blackpool
Zip: FY3 8NR
Country: United Kingdom

Facility:
Name: Western General Hospital; Edinburgh Cancer Center

Address:
City: Edinburgh
Zip: EH4 2XU
Country: United Kingdom

Facility:
Name: Christie NHS Foundation Trust

Address:
City: GB Manchester
Zip: M20 4BX
Country: United Kingdom

Facility:
Name: Castle Hill Hospital; The Queen's Centre for Oncology & Haematology

Address:
City: Hull
Zip: HU16 5JQ
Country: United Kingdom

Facility:
Name: St James University Hospital

Address:
City: Leeds
Zip: LS9 7TF
Country: United Kingdom

Facility:
Name: Leicester Royal Infirmary

Address:
City: Leicester
Zip: LE1 5WW
Country: United Kingdom

Facility:
Name: University College London Hospital

Address:
City: London
Zip: N7 9NH
Country: United Kingdom

Facility:
Name: Guy's Hospital; Oncology & Haematology Clinical Trials (OHCT) Unit. GI/Urology Research Office

Address:
City: London
Zip: SE1 9RT
Country: United Kingdom

Start date: November 18, 2021

Completion date: March 6, 2026

Lead sponsor:
Agency: Hoffmann-La Roche
Agency class: Industry

Collaborator:
Agency: Jazz Pharmaceuticals
Agency class: Industry

Source: Hoffmann-La Roche

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05091567