JOURNAL ONKOLOGIE – STUDIE
SKYSCRAPER-01
Clinical Trial
Study Director
Hoffmann-La Roche
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
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 CHRU Nantes
44093 Nantes
FranceZurückgezogen» Google-Maps CH de Saint Quentin
2100 Saint Quentin
FranceZurückgezogen» Google-Maps Centre Paul Strauss; Oncologie Medicale
67065 Strasbourg
FranceZurückgezogen» Google-Maps CHU de Toulouse - Hôpital Larrey
31059 Toulouse
FranceZurückgezogen» Google-Maps Sotiria Hospital
104 31 Athens
GreeceRekrutierend» Google-Maps Metropolitan Hospital
185 47 Athens
GreeceRekrutierend» 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 Diavalkaniko Hospital
570 01 Thessaloniki
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 Matrai Gyogyintezet
3233 Matrahaza
HungaryRekrutierend» 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 Asst Di Monza
20900 Monza
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 Aichi Cancer Center
464-8681 Aichi
JapanRekrutierend» Google-Maps National Cancer Center Hospital East
277-8577 Chiba
JapanRekrutierend» Google-Maps Kyushu University Hospital
812-8582 Fukuoka
JapanAktiv, nicht rekrutierend» Google-Maps Sendai Kousei Hospital
980-0873 Miyagi
JapanRekrutierend» 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 Kindai University Hospital
589-8511 Osaka
JapanRekrutierend» Google-Maps Saitama Cancer Center
362-0806 Saitama
JapanRekrutierend» Google-Maps National Hospital Organization Kinki-Chuo Chest Medical Center
591-8555 Sakai-shi
JapanRekrutierend» Google-Maps Shizuoka Cancer Center
411-8777 Shizuoka
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 Cuidados oncologicos
76000 Querétaro
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 Clinica Ricardo Palma
Lima 27 San Isidro
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 Center of Serbia
11000 Belgrade
SerbiaRekrutierend» 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 Sumy Regional Clinical Onc Ctr
40005 Sumy
UkraineRekrutierend» Google-Maps Uzhgorod Nat. University Central Municip Hosp; Onc Center
88000 Uzhgorod
UkraineRekrutierend» Google-Maps Alle anzeigen
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.
- 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
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))
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
Study Director
Hoffmann-La Roche
Kontakt
Kontakt:
Phone: 888-662-6728 (U.S. Only)
E-Mail: global-roche-genentech-trials@gene.com» Kontaktdaten anzeigen
Studienlocations
(3 von 172)
60488 Frankfurt
(Hessen)
GermanyRekrutierend» Google-Maps
22927 Großhansdorf
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
06120 Halle (Saale)
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
34376 Immenhausen
(Hessen)
GermanyAktiv, nicht rekrutierend» Google-Maps
74245 Loewenstein
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
48149 Münster
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
70376 Stuttgart
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
80120 Littleton
United StatesRekrutierend» Google-Maps
06520 New Haven
United StatesNoch nicht rekrutierend» Google-Maps
33705 Saint Petersburg
United StatesRekrutierend» Google-Maps
32308 Tallahassee
United StatesRekrutierend» Google-Maps
60005 Arlington Heights
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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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