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JOURNAL ONKOLOGIE – STUDIE
SKYSCRAPER-01

A Study of Tiragolumab in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer

Rekrutierend

NCT-Nummer:
NCT04294810

Studienbeginn:
März 2020

Letztes Update:
13.04.2021

Wirkstoff:
Atezolizumab, Tiragolumab, Matching Placebo

Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Hoffmann-La Roche

Collaborator:
-

Studienleiter

Clinical Trial
Study Director
Hoffmann-La Roche

Kontakt

Reference Study ID Number: GO41717 www.roche.com/about_roche/roche_worldwide.htm
Kontakt:
Phone: 888-662-6728 (U.S. Only)
E-Mail: global-roche-genentech-trials@gene.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 172)

Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie
60488 Frankfurt
(Hessen)
GermanyRekrutierend» Google-Maps
LungenClinic Großhansdorf GmbH
22927 Großhansdorf
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin I
06120 Halle (Saale)
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Fachklinik für Lungenerkrankungen
34376 Immenhausen
(Hessen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Klinik Loewenstein gGmbH; Onk & Pal
74245 Loewenstein
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Gemeinschaftspraxis für Hämatologie und Onkologie
48149 Münster
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Klinik Schillerhöhe; Pneumologische Onkologie
70376 Stuttgart
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Rocky Mountain Cancer Center - Denver
80120 Littleton
United StatesRekrutierend» Google-Maps
Yale Cancer Center
06520 New Haven
United StatesNoch nicht rekrutierend» Google-Maps
SCRI Florida Cancer Specialists North; Research Office North Region.
33705 Saint Petersburg
United StatesRekrutierend» Google-Maps
SCRI Florida Cancer Specialists PAN
32308 Tallahassee
United StatesRekrutierend» Google-Maps
Illinois Cancer Specialists
60005 Arlington Heights
United StatesRekrutierend» Google-Maps
Karmanos Cancer Institute..
48201 Detroit
United StatesZurückgezogen» Google-Maps
US oncology research at Minnesota Oncology
55404 Minneapolis
United StatesRekrutierend» Google-Maps
Onc/Hem Care Clin Trials LLC
45242 Cincinnati
United StatesRekrutierend» Google-Maps
Sarah Cannon Research Institute
37203 Nashville
United StatesRekrutierend» Google-Maps
Texas Onc-Central Austin CA Ct
78731 Austin
United StatesRekrutierend» Google-Maps
Virginia Cancer Specialists (Fairfax) - USOR
22031 Fairfax
United StatesRekrutierend» Google-Maps
Onc & Hem Assoc SW Virginia
24153 Salem
United StatesRekrutierend» Google-Maps
Northwest Cancer Specialists - Vancouver
98684 Vancouver
United StatesRekrutierend» Google-Maps
Fundación CENIT para la Investigación en Neurociencias
C1125ABD Buenos Aires
ArgentinaZurückgezogen» Google-Maps
Fundación Respirar
1426 Capital Federal
ArgentinaZurückgezogen» Google-Maps
CEMER Centro Medico de Enfermedades Respiratorias
B1602DQD Vicente López
ArgentinaZurückgezogen» Google-Maps
Clínica Viedma
8500 Viedma, Rio Negro
ArgentinaZurückgezogen» Google-Maps
St Vincent's Hospital Sydney
2010 Darlinghurst
AustraliaNoch nicht rekrutierend» Google-Maps
Princess Alexandra Hospital
4102 Woolloongabba
AustraliaRekrutierend» Google-Maps
Frankston Hospital; Oncology/Haematology
3199 Frankston
AustraliaRekrutierend» Google-Maps
Austin Hospital Olivia Newton John Cancer Centre
3084 Heidelberg
AustraliaRekrutierend» Google-Maps
Peter Maccallum Cancer Centre
3000 Melbourne
AustraliaRekrutierend» Google-Maps
Ordensklinikum Linz Elisabethinen
4020 Linz
AustriaRekrutierend» Google-Maps
Klinikum Wels-Grieskirchen; Lungenabt.
4600 Wels
AustriaRekrutierend» Google-Maps
SMZ - Baumgartner Hohe, Otto-Wagner-Spital; 2.Interne Lungenabteilung
1140 Wien
AustriaRekrutierend» Google-Maps
Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie
1210 Wien
AustriaRekrutierend» Google-Maps
Hospital de Caridade de Ijui; Oncologia
98700-000 Ijui
BrazilNoch nicht rekrutierend» Google-Maps
Hospital Sao Lucas - PUCRS
90610-000 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
Hospital de Cancer de Barretos
14784-400 Barretos
BrazilNoch nicht rekrutierend» Google-Maps
Peking Union Medical College Hospital
100032 Beijing City
ChinaNoch nicht rekrutierend» Google-Maps
Beijing Cancer Hospital
100142 Beijing
ChinaNoch nicht rekrutierend» Google-Maps
Beijing Chest Hospital; Oncology Department
101149 Beijing
ChinaNoch nicht rekrutierend» Google-Maps
The First Hospital of Jilin University
130021 Changchun City
ChinaNoch nicht rekrutierend» Google-Maps
West China Hospital, Sichuan University
610041 Chengdu
ChinaNoch nicht rekrutierend» Google-Maps
Cancer Center of Guangzhou Medical University
510000 Guangzhou
ChinaNoch nicht rekrutierend» Google-Maps
Sir Run Run Shaw Hospital Zhejiang University
310016 Hangzhou City
ChinaNoch nicht rekrutierend» Google-Maps
Harbin Medical University Cancer Hospital
150081 Harbin
ChinaNoch nicht rekrutierend» Google-Maps
Jinan Central Hospital
250013 Jinan City
ChinaNoch nicht rekrutierend» Google-Maps
The 1st Affiliated Hospital of Nanchang Unversity
330200 Nanchang City
ChinaNoch nicht rekrutierend» Google-Maps
Fudan University Shanghai Cancer Center
200120 Shanghai City
ChinaNoch nicht rekrutierend» Google-Maps
Zhongshan Hospital Fudan University
200032 Shanghai
ChinaNoch nicht rekrutierend» Google-Maps
Shanghai Pulmonary Hospital
200433 Shanghai
ChinaNoch nicht rekrutierend» Google-Maps
First Hospital of China Medical University
110001 Shenyang
ChinaNoch nicht rekrutierend» Google-Maps
Tianjin Cancer Hospital
300060 Tianjin
ChinaNoch nicht rekrutierend» Google-Maps
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
430022 Wuhan City
ChinaNoch nicht rekrutierend» Google-Maps
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
710061 Xi'an
ChinaNoch nicht rekrutierend» Google-Maps
Zhejiang Cancer Hospital
310022 Zhejiang
ChinaNoch nicht rekrutierend» Google-Maps
Aalborg Universitetshospital
9000 Aalborg
DenmarkNoch nicht rekrutierend» Google-Maps
Rigshospitalet; Onkologisk Klinik
2100 København Ø
DenmarkNoch nicht rekrutierend» Google-Maps
Sjællands Universitetshospital, Roskilde; Klinisk Onkologisk Afdeling og Palliativ Enhed
4000 Roskilde
DenmarkRekrutierend» Google-Maps
Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
33076 Bordeaux
FranceZurückgezogen» Google-Maps
Centre Hospitalier Intercommunal; Service de Pneumologie
94010 Creteil
FranceZurückgezogen» Google-Maps
Centre Georges Francois Leclerc; Recherche Clinique
21079 Dijon
FranceZurückgezogen» Google-Maps
Centre Paul Strauss; Oncologie Medicale
67065 Strasbourg
FranceZurückgezogen» Google-Maps
CHU de Toulouse - Hôpital Larrey
31059 Toulouse
FranceZurückgezogen» Google-Maps
Univ General Hosp Heraklion; Medical Oncology
711 10 Heraklion
GreeceRekrutierend» Google-Maps
University Hospital of Larissa;Department of Medical Oncology
411 10 Larissa
GreeceRekrutierend» Google-Maps
Orszagos Koranyi TBC es Pulmonologiai Intezet
1121 Budapest
HungaryAktiv, nicht rekrutierend» Google-Maps
Veszprem Megyei Onkormanyzat Tudogyogyintezete; Tudogyogyaszati Ambulancia
8582 Farkasgyepu
HungaryAktiv, nicht rekrutierend» Google-Maps
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály
5004 Szolnok
HungaryRekrutierend» Google-Maps
Azienda Ospedaliera San Giuseppe Moscati
83100 Avellino
ItalyRekrutierend» Google-Maps
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
80131 Napoli
ItalyRekrutierend» Google-Maps
A.O. Universitaria Di Parma; Oncologia Medica
43100 Parma
ItalyNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliera San Camillo Forlanini
00152 Roma
ItalyRekrutierend» Google-Maps
Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica
00168 Roma
ItalyRekrutierend» Google-Maps
Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia
20141 Milano
ItalyRekrutierend» Google-Maps
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
20089 Rozzano
ItalyRekrutierend» Google-Maps
Azienda Sanitaria Ospedaliera S Luigi Gonzaga; SSD Oncologia Polomonare (II PAD. IV PIANO)
10043 Orbassano
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
06132 Sant'Andrea Delle Fratte (PG)
ItalyRekrutierend» Google-Maps
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
35128 Padova
ItalyRekrutierend» Google-Maps
National Cancer Center Hospital East
277-8577 Chiba
JapanRekrutierend» Google-Maps
Kyushu University Hospital
812-8582 Fukuoka
JapanAktiv, nicht rekrutierend» Google-Maps
Niigata Cancer Center Hospital
951-8566 Niigata
JapanRekrutierend» Google-Maps
Okayama University Hospital
700-8558 Okayama
JapanRekrutierend» Google-Maps
Osaka International Cancer Institute
541-8567 Osaka
JapanRekrutierend» Google-Maps
National Hospital Organization Kinki-Chuo Chest Medical Center
591-8555 Sakai-shi
JapanRekrutierend» Google-Maps
National Cancer Center Hospital
104-0045 Tokyo
JapanRekrutierend» Google-Maps
The Cancer Institute Hospital of JFCR
135-8550 Tokyo
JapanAktiv, nicht rekrutierend» Google-Maps
Chungbuk National University Hospital
28644 Cheongju-si
Korea, Republic ofRekrutierend» Google-Maps
National Cancer Center
10408 Goyang-si
Korea, Republic ofRekrutierend» Google-Maps
Ajou University Medical Center
16499 Gyeonggi-do
Korea, Republic ofRekrutierend» Google-Maps
Gachon University Gil Medical Center
21565 Incheon
Korea, Republic ofRekrutierend» Google-Maps
Chonnam National University Hwasun Hospital
58128 Jeollanam-do
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Bundang Hospital
13605 Seongnam-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Samsung Medical Center
(0)6351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Kangbuk Samsung Medical Center
03181 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Severance Hospital, Yonsei University Health System
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Korea University Guro Hospital
08308 Seoul
Korea, Republic ofRekrutierend» Google-Maps
St. Vincent's Hospital
442-723 Suwon
Korea, Republic ofRekrutierend» Google-Maps
Health Pharma Professional Research
03100 Cdmx
MexicoRekrutierend» Google-Maps
Cryptex Investigacion Clinica SA de CV
06100 Mexico
MexicoRekrutierend» Google-Maps
AVIX Investigación Clínica S.C
64710 Monterrey
MexicoRekrutierend» Google-Maps
Jeroen Bosch Ziekenhuis
5223 GZ 'S Hertogenbosch
NetherlandsRekrutierend» Google-Maps
Hagaziekenhuis, locatie Leyweg
2545 AA Den-Haag
NetherlandsRekrutierend» Google-Maps
Ziekenhuis Gelderse Vallei
6716 RP EDE
NetherlandsRekrutierend» Google-Maps
Medisch Centrum Leeuwarden
8934 AD Leeuwarden
NetherlandsRekrutierend» Google-Maps
Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica
5154 Arequipa
PeruRekrutierend» Google-Maps
Instituto Nacional de Enfermedades Neoplasicas
Lima 34 Lima
PeruRekrutierend» Google-Maps
Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
Lima 41 Lima
PeruRekrutierend» Google-Maps
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
80-214 Gdańsk
PolandRekrutierend» Google-Maps
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc; Oddzial onkologii z pododdzialem chemioterapii
10-357 Olsztyn
PolandRekrutierend» Google-Maps
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
05-400 Otwock
PolandRekrutierend» Google-Maps
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
60-569 Poznan
PolandRekrutierend» Google-Maps
MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy
143422 Moscow
Russian FederationRekrutierend» Google-Maps
Main Military Clinical Hospital named after N.N. Burdenko
105229 Moscow
Russian FederationRekrutierend» Google-Maps
City Clinical Hospital #1
630047 Novosibirsk
Russian FederationAbgeschlossen» Google-Maps
Institute of Oncology
189646 St Petersburg
Russian FederationRekrutierend» Google-Maps
Leningrad Regional Clinical Hospital
194291 St Petersburg
Russian FederationRekrutierend» Google-Maps
St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research
197089 St Petersburg
Russian FederationRekrutierend» Google-Maps
St. Petersburg Clinical Scientific Center of special services medical assis (oncology)
197758 ST Petersburg
Russian FederationRekrutierend» Google-Maps
Regional Clinical Oncology Hospital
150040 Yaroslavl
Russian FederationRekrutierend» Google-Maps
Clinical Hospital Center Bezanijska Kosa
11080 Belgrade
SerbiaRekrutierend» Google-Maps
Institute for pulmonary diseases of Vojvodina
21204 Sremska Kamenica
SerbiaRekrutierend» Google-Maps
Hospital Universitario Germans Trias i Pujol
08916 Badalona
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario Puerta de Hierro - Majadahonda
28220 Majadahonda
SpainRekrutierend» Google-Maps
Hospital General Universitario de Alicante
03010 Alicante
SpainRekrutierend» Google-Maps
Hospital Universitario Vall d'Hebron - PPDS
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario 12 De Octubre
28041 Madrid
SpainRekrutierend» Google-Maps
Hospital Regional Universitario de Malaga
29010 Malaga
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen del Rocío
41013 Sevilla
SpainAktiv, nicht rekrutierend» Google-Maps
Hosp Clinico Univ Lozano Blesa; División De Oncología Médica
50009 Zaragoza
SpainAktiv, nicht rekrutierend» Google-Maps
Universitaetsspital Basel; Onkologie
4031 Basel
SwitzerlandRekrutierend» Google-Maps
Inselspital Bern; Universitätsklinik für medizinische Onkologie
3010 Bern
SwitzerlandRekrutierend» Google-Maps
CHUV; Departement d'Oncologie
1011 Lausanne
SwitzerlandRekrutierend» Google-Maps
Kantonsspital St. Gallen; Klinik fuer Onkologie und Haematologie
9000 St. Gallen
SwitzerlandRekrutierend» Google-Maps
Kaohsiung Medical University Chung-Ho Memorial Hospital
807 Kaohsiung City
TaiwanRekrutierend» Google-Maps
Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
83301 Kaohsiung
TaiwanRekrutierend» Google-Maps
Taipei Medical University -Shuang Ho Hospital
23561 New Taipei City
TaiwanRekrutierend» Google-Maps
Taichung Veterans General Hospital; Dept of Internal Medicine
407 Taichung
TaiwanNoch nicht rekrutierend» Google-Maps
National Cheng Kung Uni Hospital; Dept of Hematology and Oncology
704 Tainan
TaiwanRekrutierend» Google-Maps
Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
112 Taipei
TaiwanAktiv, nicht rekrutierend» Google-Maps
Chang Gung Memorial Hospital - Linkou Branch
Taipei
TaiwanAktiv, nicht rekrutierend» Google-Maps
National Taiwan University Hospital; Oncology
10048 Zhongzheng Dist.
TaiwanRekrutierend» Google-Maps
Chulalongkorn Hospital; Medical Oncology
10330 Bangkok
ThailandRekrutierend» Google-Maps
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
10400 Bangkok
ThailandRekrutierend» Google-Maps
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
10700 Bangkok
ThailandRekrutierend» Google-Maps
Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory
90110 Songkhla
ThailandRekrutierend» Google-Maps
Adana Baskent University Hospital; Medical Oncology
01120 Adana
TurkeyRekrutierend» Google-Maps
Hacettepe University Medical Faculty
06100 Ankara
TurkeyRekrutierend» Google-Maps
Istanbul University Cerrahpasa Faculty of Medicine
34098 Istanbul
TurkeyRekrutierend» Google-Maps
Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
35110 Izmir
TurkeyAktiv, nicht rekrutierend» Google-Maps
Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
34722 Kadiköy
TurkeyRekrutierend» Google-Maps
Inonu University Medical Faculty of Medicine; Medical Oncology Department
44280 Malatya
TurkeyAktiv, nicht rekrutierend» Google-Maps
City Clinical Hospital #4
49102 Dnipropetrovsk
UkraineRekrutierend» Google-Maps
Ivano-Frankivsk Regional Oncology Center
76018 Ivano-Frankivsk
UkraineRekrutierend» Google-Maps
ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department
50048 Kryvyi Rih
UkraineRekrutierend» Google-Maps
Uzhgorod Nat. University Central Municip Hosp; Onc Center
88000 Uzhgorod
UkraineRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of the study is to evaluate the efficacy and safety of tiragolumab plus

atezolizumab compared with placebo plus atezolizumab in participants with previously

untreated locally advanced, unresectable or metastatic PD-L1-selected non-small cell lung

cancer (NSCLC), with no epidermal growth factor receptor (EGFR) mutation or anaplastic

lymphoma kinase (ALK) translocation. Eligible participants will be randomized in a 1:1 ratio

to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histologically or cytologically documented locally advanced or recurrent NSCLC not

eligible for curative surgery and/or definitive radiotherapy with or without

chemoradiotherapy, or metastatic Stage IV non-squamous or squamous NSCLC

- No prior systemic treatment for metastatic NSCLC

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- High tumor tissue PD-L1 expression

- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1

(RECIST v1.1)

- Adequate hematologic and end-organ function

Exclusion Criteria:

- Known mutation in the EGFR gene or an ALK fusion oncogene

- Symptomatic, untreated, or actively progressing central nervous system metastases

- 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

- Malignancies other than NSCLC within 5 years, with the exception of those with a

negligible risk of metastasis or death treated with expected curative outcome

- Severe infection within 4 weeks prior to initiation of study treatment

- Positive test result for human immunodeficiency virus (HIV)

- Active hepatitis B or hepatitis C

- Treatment with investigational therapy within 28 days prior to initiation of study

treatment

- Prior treatment with CD137 agonists or immune checkpoint blockade therapies,

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 initiation of study treatment

Studien-Rationale

Primary outcome:

1. Investigator-Assessed Progression-Free Survival (PFS) in the Primary Population (Time Frame - From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months))

2. Overall Survival (OS) in the Primary Population (Time Frame - From randomization to death from any cause (up to approximately 59 months))

Secondary outcome:

1. Investigator-Assessed PFS in the Secondary Population (Time Frame - From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months))

2. OS in the Secondary Population (Time Frame - From randomization to death from any cause (up to approximately 59 months))

3. Investigator-Assessed PFS in Participants With High Tumor Programmed Death-Ligand 1 (PD-L1) Expression (Time Frame - From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months))

4. OS in Participants With High Tumor PD-L1 Expression (Time Frame - From randomization to death from any cause (up to approximately 59 months))

5. Investigator-Assessed Confirmed Objective Response Rate (ORR) (Time Frame - From randomization up to approximately 59 months)

6. Investigator-Assessed Duration of Response (DOR) (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 approximately 59 months))

7. Investigator-Assessed PFS Rates at 6 Months and 12 Months (Time Frame - 6 months, 12 months)

8. OS Rates at 12 Months and 24 Months (Time Frame - 12 months, 24 months)

9. Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score (Time Frame - From randomization until the first confirmed clinically meaningful deterioration (up to approximately 59 months)):
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.

10. Percentage of Participants With Adverse Events (AEs) (Time Frame - Up to approximately 59 months)

11. Minimum Serum Concentration (Cmin) of Tiragolumab (Time Frame - Predose and postdose on Day 1 of Cycle 1 (cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at treatment discontinuation (TD) visit (up to approximately 59 months))

12. Maximum Serum Concentration (Cmax) of Tiragolumab (Time Frame - Predose and postdose on Day 1 of Cycle 1 (cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to approximately 59 months))

13. Cmin of Atezolizumab (Time Frame - Predose and postdose on Day 1 of Cycle 1 (cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to approximately 59 months))

14. Cmax of Atezolizumab (Time Frame - Predose and postdose on Day 1 of Cycle 1 (cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to approximately 59 months))

15. Percentage of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab (Time Frame - Predose on Day 1 of Cycles (cycle=21 days) 1, 2, 3, 4, 8,12 and 16 and at TD visit (up to approximately 59 months))

16. Percentage of Participants With ADAs to Atezolizumab (Time Frame - Predose on Day 1 of Cycles (cycle=21 days) 1, 2, 3, 4, 8,12 and 16 and at TD visit (up to approximately 59 months))

Studien-Arme

  • Experimental: Tiragolumab + Atezolizumab
    Participants will receive atezolizumab followed by tiragolumab every 3 weeks (Q3W) on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity.
  • Placebo Comparator: Placebo + Atezolizumab
    Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity.

Geprüfte Regime

  • Atezolizumab (Tecentriq):
    Atezolizumab 1200 milligrams (mg) administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.
  • Tiragolumab (MTIG7192A):
    Tiragolumab 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
  • Matching Placebo:
    Matching Placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.

Quelle: ClinicalTrials.gov


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