- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04256421
A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer (SKYSCRAPER-02)
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab (Anti-Tigit Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
This study will evaluate the efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with chemotherapy-naive extensive-stage small cell lung cancer (ES-SCLC). Eligible participants will be stratified by Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), LDH (</= upper limit of normal [ULN] vs. > ULN), and presence or history of brain metastasis (yes vs. no) and randomly assigned in a 1:1 ratio to receive one of the following treatment regimens during induction phase:
- Arm A: Tiragolumab plus atezolizumab plus CE
- Arm B: Placebo plus atezolizumab plus CE
Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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New South Wales
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Camperdown, New South Wales, Australia, 2050
- Chris O'Brien Lifehouse
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Kingswood, New South Wales, Australia, 2747
- Nepean Hospital; Nepean Cancer Care Centre
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Queensland
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Birtinya, Queensland, Australia, 4575
- Sunshine Coast University Hospital; The Adem Crosby Centre
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South Australia
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Elizabeth Vale, South Australia, Australia, 5112
- Lyell McEwin Hospital; Oncology Clinical Trials, Chemotherapy Day Unit
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Innsbruck, Austria, 6020
- Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
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Wien, Austria, 1210
- Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie
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Wien, Austria, 1140
- Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten
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Mechelen, Belgium, 2800
- AZ St Maarten Campus Leopoldstr
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Namur, Belgium, 5000
- Clinique Ste-Elisabeth
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Roeselare, Belgium, 8800
- AZ Delta (Campus Rumbeke)
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Sint Niklaas, Belgium, 9100
- Vitaz
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BA
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Salvador, BA, Brazil, 41253-190
- Hospital Sao Rafael - HSR
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CE
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Fortaleza, CE, Brazil, 60130-241
- Oncocentro Servicos Medicos e Hospitalares Ltda
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RS
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Passo Fundo, RS, Brazil, 99010-260
- Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia
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Porto Alegre, RS, Brazil, 91350-200
- Hospital Nossa Senhora da Conceicao
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SC
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Blumenau, SC, Brazil, 89010-340
- Clinica de Oncologia Reichow
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SP
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Sao Paulo, SP, Brazil, 01246-000
- Instituto do Cancer do Estado de Sao Paulo - ICESP
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Olomouc, Czechia, 779 00
- Fakultni nemocnice Olomouc; Pneumologicka klinika
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Ostrava, Czechia, 703 84
- Vitkovicka Nemocnice Bma, A.S.; Plicni Oddeleni
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Praha 4 - Krc, Czechia, 140 59
- Thomayerova nemocnice; Pneumologicka klinika 1.LF UK TN
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Berlin, Germany, 14165
- Helios Klinikum Emil von Behring GmbH
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Gauting, Germany, 82131
- Asklepios Klinik Gauting; Onkologisches Studienzentrum
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Großhansdorf, Germany, 22927
- LungenClinic Grosshansdorf GmbH
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Hamburg, Germany, 21075
- Asklepios Klinik Harburg
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Immenhausen, Germany, 34376
- Fachklinik für Lungenerkrankungen
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Lübeck, Germany, 23538
- Universitätsklinikum Schleswig-Holstein; Campus Lübeck
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Asvestochori, Greece, 570 10
- General Hospital "G.Papanikolaou"; Pulmonogy Clinic
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Athens, Greece, 115 27
- Uoa Sotiria Hospital; Oncology
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Cholargos, Greece, 155 62
- Metropolitan General Hospital
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Heraklion, Greece, 711 10
- Univ General Hosp Heraklion; Medical Oncology
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Budapest, Hungary, 1121
- Orszagos Koranyi Tbc es Pulmonologiai Intezet
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Szolnok, Hungary, 5000
- Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
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Torokbalint, Hungary, 2045
- Tudogyogyintezet Torokbalint
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Campania
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Napoli, Campania, Italy, 80131
- AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico
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Emilia-Romagna
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Ravenna, Emilia-Romagna, Italy, 48121
- AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia
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Lombardia
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Rozzano (MI), Lombardia, Italy, 20089
- IRCCS Istituto Clinico Humanitas; Oncologia
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Piemonte
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Orbassano, Piemonte, Italy, 10043
- Azienda Sanitaria Ospedaliera S Luigi Gonzaga
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Puglia
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Bari, Puglia, Italy, 70124
- Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
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Sicilia
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Catania, Sicilia, Italy, 95123
- Azienda Ospedaliero-Universitaria ?PoliclinicoVittorio Emanuele?- P.O. G. Rodolico; Oncologia Medica
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Toscana
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Siena, Toscana, Italy, 53100
- Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
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Veneto
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Padova, Veneto, Italy, 35128
- IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
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Chiba, Japan, 277-8577
- National Cancer Center Hospital East
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Fukuoka, Japan, 812-8582
- Kyushu University Hospital
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Niigata, Japan, 951-8566
- Niigata Cancer Center Hospital
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Osaka, Japan, 589-8511
- Kindai University Hospital
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Osaka, Japan, 541-8567
- Osaka International Cancer Institute
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Saitama, Japan, 362-0806
- Saitama Cancer Center
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Sakai-shi, Japan, 591-8555
- National Hospital Organization Kinki-chuo Chest Medical Center
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Shizuoka, Japan, 411-8777
- Shizuoka Cancer Center
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Tokyo, Japan, 104-0045
- National Cancer Center Hospital
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Tokyo, Japan, 135-8550
- The Cancer Institute Hospital of JFCR
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Wakayama, Japan, 641-8510
- Wakayama Medical University Hospital
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Cheongju-si, Korea, Republic of, 28644
- Chungbuk National University Hospital
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Goyang-si, Korea, Republic of, 10408
- National Cancer Center
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Gyeongsangnam-do, Korea, Republic of, 51353
- Samsung Changwon Hospital
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Seongnam-si, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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Seoul, Korea, Republic of, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, Korea, Republic of, 05505
- Asan Medical Center
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Seoul, Korea, Republic of, 06351
- Samsung Medical Center
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Seoul, Korea, Republic of, 06591
- Seoul St Mary's Hospital
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Ulsan, Korea, Republic of, 44033
- Ulsan University Hosiptal
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Maastricht, Netherlands, 6229 HX
- Maastricht University Medical Center
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Rotterdam, Netherlands, 3015 GD
- Erasmus MC
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Auckland, New Zealand, 1023
- Auckland City Hospital; Clinical Oncology
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Brzozów, Poland, 36-200
- Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny
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Gdansk, Poland, 80-214
- Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
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Krakow, Poland, 31-202
- Krakowski Szpital Specjalistyczny im sw.Jana Pawla II
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Olsztyn, Poland, 10-357
- Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
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Otwock, Poland, 05-400
- Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
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Poznan, Poland, 60-569
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
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Warszawa, Poland, 02-781
- Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers
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Moskovskaja Oblast
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Moscow, Moskovskaja Oblast, Russian Federation, 105229
- Principal Military Clinical Hospital n.a. N.N. Burdenko
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Moscow, Moskovskaja Oblast, Russian Federation
- BLOKHIN CANCER RESEARCH CENTER; CLINICAL ONCOLOGY; Clinical pharmacology and chemotheraphy
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Sankt Petersburg
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Saint Petersburg, Sankt Petersburg, Russian Federation, 187758
- Scientific Research Institute n.a. N.N. Petrov
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Belgrade, Serbia, 11000
- Clinical Center of Serbia; Clinic for Pulmonary Diseases
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Belgrade, Serbia, 11080
- Clinical Hospital Center ''Bezanijska Kosa''; Department of Pulmology
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Sremska Kamenica, Serbia, 21204
- Institute for Pulmonary Diseases of Vojvodina; Clinic for Pulmonary Oncology
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Singapore, Singapore, 119228
- National University Hospital; National University Cancer Institute, Singapore (NCIS)
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Singapore, Singapore, 168583
- National Cancer Centre; Medical Oncology
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Barcelona, Spain, 08036
- Hospital Clinic Barcelona; Servicio de oncologia
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Barcelona, Spain, 08035
- Vall d?Hebron Institute of Oncology (VHIO), Barcelona
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Madrid, Spain, 28046
- Hospital Universitario La Paz; Servicio de Oncologia
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Madrid, Spain, 28040
- Fundacion Jimenez Diaz; Servicio de Oncologia
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Malaga, Spain, 29010
- Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
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Sevilla, Spain, 41013
- Hospital Universitario Virgen del Rocio; Servicio de Oncologia
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Valencia, Spain, 46010
- Hospital Clínico Universitario de Valencia; Servicio de Oncología
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Zaragoza, Spain, 50009
- Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia
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Lausanne, Switzerland, 1011
- CHUV; Departement d'Oncologie
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Zürich, Switzerland, 8091
- UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
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Tainan, Taiwan
- National Cheng-Kung University Hospital
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Taipei City, Taiwan, 11217
- Taipei Veterans General Hospital
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Taoyuan, Taiwan, 333
- Chang-Gung Medical Foundation, Linkou Branch
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Zhongzheng Dist., Taiwan, 10048
- National Taiwan University Hospital; Oncology
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Adana, Turkey, 01120
- Adana Baskent University Hospital; Medical Oncology
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Ankara, Turkey, 06100
- Ankara University Medical Faculty; Medikal Onkoloji
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Ankara, Turkey, 06500
- Gazi University Medical Faculty
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Istanbul, Turkey, 34214
- Medipol University Medical Faculty; Oncology Department
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Istanbul, Turkey, 34098
- Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty; Medikal Onkoloji Departmani
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Izmir, Turkey
- ?zmir Medical Park; Onkoloji
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Edinburgh, United Kingdom, EH4 2XU
- NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital
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London, United Kingdom, SE1 9RT
- Guys and St Thomas Hospital
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Manchester, United Kingdom, M20 4BX
- Christie Foundation Trust
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Sutton, United Kingdom, SM2 5PT
- Royal Marsden Hospital (Sutton)
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Truro, United Kingdom, TR1 3LQ
- Royal Cornwall Hospital
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Colorado
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Lone Tree, Colorado, United States, 80124
- Rocky Mountain Cancer Centers - Lone Tree
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District of Columbia
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Washington, District of Columbia, United States, 20007
- MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)
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Florida
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Fort Myers, Florida, United States, 33901
- Florida Cancer Specialists; SCRI; Florida Cancer Specialists - Sarasota (Golf St)
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Saint Petersburg, Florida, United States, 33705
- SCRI Florida Cancer Specialists North; Research Office North Region.
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Georgia
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Marietta, Georgia, United States, 30060
- Northwest Georgia Oncology Centers PC - Marietta
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Illinois
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Peoria, Illinois, United States, 61615
- Illinois Cancer Care
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Maine
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Scarborough, Maine, United States, 04074
- New England Cancer Specialists
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Maryland
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Baltimore, Maryland, United States, 21237
- Weinberg Cancer Institution at Franklin Square
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Minnesota
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Saint Paul, Minnesota, United States, 55102
- Minnesota Oncology Hematology
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Nevada
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Las Vegas, Nevada, United States, 89128
- Comprehensive Cancer Centers of Nevada
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New York
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Binghamton, New York, United States, 13905
- Broome Oncology - Binghamton
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New York, New York, United States, 11101
- Memorial Sloan Kettering Cancer Center
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New York, New York, United States, 10029
- Mount Sinai - PRIME; Icahn School of Medicine at Mount Sinai
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- SCRI Tennessee Oncology Chattanooga
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Nashville, Tennessee, United States, 37203
- SARAH CANNON RESEARCH INST.; Tennessee Oncology, PLLC
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Texas
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Austin, Texas, United States, 78731
- Texas Oncology Cancer Center
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Virginia
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Fairfax, Virginia, United States, 22031
- Virginia Cancer Specialists
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Roanoke, Virginia, United States, 24014
- Blue Ridge Cancer Care
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin School of Medicine and Public Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC)
- No prior systemic treatment for ES-SCLC
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- Adequate hematologic and end-organ function
- 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
Exclusion Criteria:
- Symptomatic or actively progressing central nervous system (CNS) metastases
- Malignancies other than small cell lung cancer (SCLC) within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
- Active or history of autoimmune disease or immune deficiency
- 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
- Positive test result for human immunodeficiency virus (HIV)
- Active hepatitis B or hepatitis C
- Severe infection at the time of randomization
- Treatment with any other investigational agent within 28 days prior to initiation of study treatment
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-cytotoxic T lymphocyte-associated protein 4 (anti-CTLA-4), anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug elimination half-lives prior to randomization
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Tiragolumab + Atezolizumab + CE
Participants will receive atezolizumab on Day 1 of each 21-day cycle followed by tiragolumab on Day 1 of each 21-day cycle.
Carboplatin will be administered followed by etoposide on Day 1 for 4 cycles.
Participants will also receive etoposide on Days 2 and 3.
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Tiragolumab 600 milligrams (mg) administered by IV infusion on Day 1 of each 21-day cycle.
Other Names:
Atezolizumab 1200 mg administered by IV infusion on Day 1 of each 21-day cycle.
Other Names:
Carboplatin was administered by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
Etoposide 100 mg/m^2 administered by IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles.
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Active Comparator: Placebo + Atezolizumab + CE
Participants will receive atezolizumab on Day 1 of each 21-day cycle followed by placebo on Day 1 of each 21-day cycle.
Carboplatin will be administered followed by etoposide on Day 1 for 4 cycles.
Participants will also receive etoposide on Days 2 and 3.
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Atezolizumab 1200 mg administered by IV infusion on Day 1 of each 21-day cycle.
Other Names:
Carboplatin was administered by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
Etoposide 100 mg/m^2 administered by IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles.
Placebo administered by IV infusion on Day 1 of each 21-day cycle.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Investigator-Assessed Progression Free Survival (PFS) in the Primary Analysis Set (PAS)
Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 50 months)
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From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 50 months)
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Overall Survival (OS) in the PAS
Time Frame: From randomization to death from any cause (up to 50 months)
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From randomization to death from any cause (up to 50 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS in the Full Analysis Set (FAS)
Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 50 months)
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From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 50 months)
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OS in the FAS
Time Frame: From randomization to death from any cause (up to 50 months)
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From randomization to death from any cause (up to 50 months)
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Investigator-Assessed Confirmed Objective Response Rate (ORR) in the PAS
Time Frame: From randomization up to 50 months
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From randomization up to 50 months
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Investigator-Assessed Confirmed ORR in the FAS
Time Frame: From randomization up to 50 months
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From randomization up to 50 months
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Investigator-Assessed PFS Rates at 6 Months and 12 Months in the PAS
Time Frame: 6 months, 12 months
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6 months, 12 months
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Investigator-Assessed PFS Rates at 6 Months and 12 Months in the FAS
Time Frame: 6 months, 12 months
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6 months, 12 months
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Overall Survival Rates at 12 Months and 24 Months in the PAS
Time Frame: 12 months, 24 months
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12 months, 24 months
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Overall Survival Rates at 12 Months and 24 Months in the FAS
Time Frame: 12 months, 24 months
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12 months, 24 months
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Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score in the PAS
Time Frame: From randomization until the first confirmed clinically meaningful deterioration up to 50 months
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TTCD using EORTC QLQ-C30 is an initial 10-point decrease in global health status (GHS)/quality of life (QoL) and functioning from baseline that must be held for at least two consecutive assessments or an initial clinically meaningful decrease above baseline followed by death.
EORTC QLQ-C30: a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting and pain), GHS and QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) with a recall period of the previous week.
Functioning items are scored on a 4-point scale: 1=Not at all to 4=Very much, with higher score indicating worse outcome.
Symptom items (GHS and QoL) are scored on a 7-point scale: 1=Very poor to 7=Excellent.
Scores will be linearly transformed with a minimum score of 0 and maximum score of 100.
Higher score indicates better outcome.
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From randomization until the first confirmed clinically meaningful deterioration up to 50 months
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TTCD Assessed Using EORTC QLQ-C30 Score in the FAS
Time Frame: From randomization until the first confirmed clinically meaningful deterioration up to 50 months
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TTCD using EORTC QLQ-C30 is an initial 10-point decrease in global health status (GHS)/quality of life (QoL) and functioning from baseline that must be held for at least two consecutive assessments or an initial clinically meaningful decrease above baseline followed by death.
EORTC QLQ-C30: a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting and pain), GHS and QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) with a recall period of the previous week.
Functioning items are scored on a 4-point scale: 1=Not at all to 4=Very much, with higher score indicating worse outcome.
Symptom items (GHS and QoL) are scored on a 7-point scale: 1=Very poor to 7=Excellent.
Scores will be linearly transformed with a minimum score of 0 and maximum score of 100.
Higher score indicates better outcome.
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From randomization until the first confirmed clinically meaningful deterioration up to 50 months
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Percentage of Participants With Adverse Events
Time Frame: Up to 50 months
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Up to 50 months
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Cmin of Atezolizumab
Time Frame: Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to 50 months)
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Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to 50 months)
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Maximum Serum Concentration (Cmax) of Tiragolumab
Time Frame: Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to 50 months)
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Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to 50 months)
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Cmax of Atezolizumab
Time Frame: Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to 50 months)
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Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to 50 months)
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Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab
Time Frame: Predose on Day 1 of Cycles 1 (each cycle is 21 days), 2, 3, 4, 8,12 and 16 and at TD visit (up to 50 months)
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Predose on Day 1 of Cycles 1 (each cycle is 21 days), 2, 3, 4, 8,12 and 16 and at TD visit (up to 50 months)
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Percentage of Participants With ADAs to Atezolizumab
Time Frame: Predose on Day 1 of Cycles 1 (each cycle is 21 days), 2, 3, 4, 8,12 and 16 and at TD visit (up to 50 months)
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Predose on Day 1 of Cycles 1 (each cycle is 21 days), 2, 3, 4, 8,12 and 16 and at TD visit (up to 50 months)
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Change from Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index-based and Visual Analog Scale Scores
Time Frame: From baseline up to 50 months
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The EQ-5D-5L is a validated self-report health status questionnaire that is used to calculate a health status utility score for use in health economic analyses.
There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a visual analog scale (VAS) that measures health state.
A single composite score is calculated based on the responses as an indicator of the participant's health status.
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From baseline up to 50 months
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Investigator-Assessed Duration of Response (DOR) in the PAS
Time Frame: From the first occurrence of a documented confirmed objective response to disease progression or death from any cause, whichever occurs first (up to 50 months)
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From the first occurrence of a documented confirmed objective response to disease progression or death from any cause, whichever occurs first (up to 50 months)
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Investigator-Assessed DOR in the FAS
Time Frame: From the first occurrence of a documented confirmed objective response to disease progression or death from any cause, whichever occurs first (up to 50 months)
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From the first occurrence of a documented confirmed objective response to disease progression or death from any cause, whichever occurs first (up to 50 months)
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Minimum Serum Concentration (Cmin) of Tiragolumab
Time Frame: Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at treatment discontinuation (TD) visit (up to 50 months)
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Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at treatment discontinuation (TD) visit (up to 50 months)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Carboplatin
- Etoposide
- Atezolizumab
Other Study ID Numbers
- GO41767
- 2019-003301-97 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Small Cell Lung Cancer
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AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
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University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
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WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
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National Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung CancerUnited States
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University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
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Washington University School of MedicineMerck Sharp & Dohme LLCWithdrawnNSCLC | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Small Cell Lung Extensive Stage
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Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedTobacco Use Disorder | Stage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Limited Stage Small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB...United States
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Shanghai Chest HospitalRecruitingSmall Cell Lung Carcinoma | Small-cell Lung Cancer | Small Cell Lung Cancer Limited Stage | Small Cell Lung Cancer Extensive Stage | Small Cell Lung Cancer, Combined TypeChina
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Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
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National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
Clinical Trials on Tiragolumab
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Yonsei UniversityNot yet recruitingNon-small Cell Lung CancerKorea, Republic of
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Alain AlgaziGenentech, Inc.RecruitingCarcinoma | Cancer | Head and Neck Cancer | Squamous Cell CarcinomaUnited States
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Hoffmann-La RocheActive, not recruitingEsophageal Squamous Cell CarcinomaUnited States, France, Spain, Australia, Korea, Republic of, Argentina, Belgium, China, Portugal, Taiwan, Japan, Germany, Poland, Thailand, United Kingdom, Switzerland, Turkey, Russian Federation, Morocco, Greece, Italy, New Zealand, South Africa and more
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Hoffmann-La RocheActive, not recruiting
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Hoffmann-La RocheActive, not recruitingEsophageal CancerKorea, Republic of, China, Hong Kong, Thailand, Taiwan
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Hoffmann-La RocheRecruitingUrothelial CancerKorea, Republic of, United States, Brazil, China, France, Germany, Mexico, Poland, Denmark, Turkey, Australia, Greece, Spain, United Kingdom, Italy
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M.D. Anderson Cancer CenterRecruitingMetastatic MalignancyUnited States
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Hoffmann-La RocheActive, not recruitingNon-small Cell Lung Cancer (NSCLC)United States, Belgium, Korea, Republic of, Canada, China, Denmark, Spain, Thailand, United Kingdom, Taiwan, Brazil, Germany, Mexico, Italy, Switzerland, Hong Kong, Japan, France, Turkey, New Zealand, Kenya, Poland
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Washington University School of MedicineGenentech, Inc.Terminated
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Hoffmann-La RocheRecruitingPD-L1-selected Solid TumorsKorea, Republic of, United States, Spain, Taiwan, Turkey, Greece, Canada, Croatia, Serbia, Mexico, Cyprus