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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

660

Participants

Timeline

Start Date

November 18, 2021

Primary Completion Date

July 29, 2024

Study Completion Date

August 13, 2026

Conditions
Small-Cell Lung Cancer
Interventions
DRUG

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.

DRUG

Lurbinectedin

Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 of each 21-day cycle in the maintenance phase.

DRUG

Carboplatin

Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.

DRUG

Etoposide

Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.

Trial Locations (92)

112

Taipei Veterans General Hospital, Taipei

407

Taichung Veterans General Hospital, Taichung

824

E-DA Hospital, Kaohsiung City

1070

Institut Jules Bordet, Anderlecht

1121

Orszagos Koranyi Pulmonologiai Intezet, Budapest

2045

Tudogyogyintezet Torokbalint, Törökbálint

2800

AZ St Maarten Campus Leopoldstr, Mechelen

3000

UZ Leuven Gasthuisberg, Leuven

3500

Jessa Zkh (Campus Virga Jesse), Hasselt

5000

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int., Szolnok

5530

CHU UCL Mont-Godinne, Mont-godinne

7623

Pécsi Tudományegyetem, Pécs

9100

Vitaz, Sint-Niklaas

11526

Errikos Dynan Hospital, Athens

11590

Clinical Research Alliance, Westbury

13125

Evang. Lungenklinik Berlin Klinik für Pneumologie, Berlin

13605

Seoul National University Bundang Hospital, Seongnam-si

15006

Complejo Hospitalario Universitario A Coruña (CHUAC), A Coruña

16059

Uludag Uni Hospital, Bursa

16125

ASL 3 Genovese, Genoa

19111

Fox Chase Cancer Center, Philadelphia

20070

Pamukkale University School Of Medicine, Denizli

20141

Irccs Istituto Europeo di Oncologia (IEO), Milan

20162

Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda), Milan

22030

Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi, Edirne

22927

LungenClinic Großhansdorf GmbH, Großhansdorf

23538

Universitätsklinikum Schleswig-Holstein, Lübeck

28041

Hospital Universitario 12 de Octubre, Madrid

28644

Chungbuk National University Hospital, Cheongju-si

29010

Hospital Clinico Universitario Virgen de la Victoria, Málaga

29425

Hollings Cancer Center, Charleston

30060

Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital, Marietta

31380

Kocaeli University Faculty of Medicine, İzmit

33401

Florida Cancer Specialists, West Palm Beach

34214

Ba?c?lar Medipol Mega Üniversite Hastanesi, Istanbul

34300

Istanbul Uni Cerrahpasa Medical Faculty Hospital, Istanbul

34376

Fachklinik für Lungenerkrankungen, Immenhausen

34660

Ac?badem Altunizade Hastanesi, Istanbul

34722

Goztepe Prof.Dr. Suleyman Yalcin City Hospital, Kadiköy

35101

Izmir Medical Point Hospital, Izmir

37203

Sarah Cannon Research Institute / Tennessee Oncology, Nashville

37403

Greco-Hainesworth Centers for Research, Chattanooga

38138

West Clinic, Germantown

41013

Hospital Universitario Virgen del Rocio, Seville

42080

TC Necmettin Erbakan University Meram Medical Faculty Hospital, Selçuklu

43219

The Mark H. Zangmeister Ctr, Columbus

44033

Ulsan University Hosiptal, Ulsan

45136

KEM/Evang. Kliniken Essen Mitte gGmbH, Essen

48121

AUSL della Romagna, Ravenna

49124

Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH, Georgsmarienhütte

49503

Cancer & Hematology Centers of Western Michigan, Grand Rapids

51353

Samsung Changwon Hospital, Gyeongsangnam-do

52727

Gyeongsang National University Hospital, Gyeongsangnam-do

55200

Medikal Park Samsun, Samsun

58260

Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde, Morelia

60126

Azienda Ospedaliero Universitaria Ospedali Riuniti, Torrette Di Ancona

61615

Illinois Cancer Care, Peoria

63141

Mercy Research - St. Louis, St Louis

82131

Asklepios Klinik Gauting, München-Gauting

99437

Zentralklinik Bad Berka GmbH, Bad Berka

04074

New England Cancer Specialists, Scarborough

02215

Dana Farber Cancer Institute, Boston

02903

Rhode Island Hospital, Providence

09116

Klinikum Chemnitz gGmbH, Chemnitz

115 27

Sotiria Thoracic Diseases Hospital of Athens, Athens

411 10

University Hospital of Larissa, Larissa

546 45

Euromedical General Clinic of Thessaloniki, Thessaloniki

570 01

Diavalkaniko Hospital, Thessaloniki

03100

Health Pharma Professional Research, Mexico City

80-214

Uniwersyteckie Centrum Kliniczne, Gda?sk

31-202

Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II, Krakow

10-357

Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie, Olsztyn

05-400

Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy, Otwock

60-569

Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu, Poznan

02-781

Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie, Warsaw

702-210

Chilgok Kyungpook National University Medical Center, Daegu

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08003

Hospital del Mar, Barcelona

08035

Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Barcelona

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

00704

National Cheng Kung University Hospital, Tainan City

01120

Adana Baskent University Hospital, Adana

06520

Memorial Ankara Hastanesi, Ankara

06680

Liv Hospital Ankara, Ankara

06800

Ankara City Hospital, Ankara

FY3 8NR

Blackpool Victoria Hospital, Blackpool

M20 4BX

Christie NHS Foundation Trust, GB Manchester

HU16 5JQ

Castle Hill Hospital, Hull

LS9 7TF

St James University Hospital, Leeds

LE1 5WW

Leicester Royal Infirmary, Leicester

SE1 9RT

Guy's Hospital, London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Jazz Pharmaceuticals

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY