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
SKYSCRAPER-01
A Phase III, Randomized, Double-Blinded, Placebo-Controlled Study of Tiragolumab, an Anti-Tigit Antibody, 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
3 other identifiers
interventional
620
22 countries
131
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 nonsmall-cell-lung-cancer
Started Mar 2020
Typical duration for phase_3 nonsmall-cell-lung-cancer
131 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2020
CompletedFirst Posted
Study publicly available on registry
March 4, 2020
CompletedStudy Start
First participant enrolled
March 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedJanuary 30, 2026
January 1, 2026
5.8 years
March 2, 2020
January 29, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Investigator-Assessed Progression-Free Survival (PFS) in the Primary Analysis Set
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
Overall Survival (OS) in the Primary Analysis Set
From randomization to death from any cause (up to approximately 59 months)
Percentage of Participants With Adverse Events (AEs)
Up to approximately 59 months
Percentage of Participants With Cytokine-Release Syndrome (CRS)
Up to approximately 59 months
Secondary Outcomes (7)
Investigator-Assessed PFS in the Secondary Analysis Set
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
OS in the Secondary Analysis Set
From randomization to death from any cause (up to approximately 59 months)
Investigator-Assessed Confirmed Objective Response Rate (ORR)
From randomization up to approximately 59 months
Investigator-Assessed Duration of Response (DOR)
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)
Investigator-Assessed PFS Rates at 6 Months and 12 Months
6 months, 12 months
- +2 more secondary outcomes
Study Arms (2)
Tiragolumab + Atezolizumab
EXPERIMENTALParticipants 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 + Atezolizumab
PLACEBO COMPARATORParticipants 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.
Interventions
Atezolizumab 1200 milligrams (mg) administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.
Tiragolumab 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Matching Placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Eligibility Criteria
You may qualify if:
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- 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
- 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
- For participants enrolled in the extended China enrollment phase: current resident of mainland China or Taiwan and of Chinese ancestry.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (134)
Rocky Mountain Cancer Center - Denver
Denver, Colorado, 80220, United States
Yale Cancer Center
New Haven, Connecticut, 06520, United States
SCRI Florida Cancer Specialists North
St. Petersburg, Florida, 33705, United States
SCRI Florida Cancer Specialists PAN
Tallahassee, Florida, 32308, United States
US oncology research at Minnesota Oncology
Saint Paul, Minnesota, 55102, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Virginia Cancer Specialists (Fairfax) - USOR
Fairfax, Virginia, 22031, United States
Onc & Hem Assoc SW Virginia
Salem, Virginia, 24153, United States
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, 98684, United States
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Austin Hospital Olivia Newton John Cancer Centre
Heidelberg, Victoria, 3084, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Ordensklinikum Linz Elisabethinen
Linz, 4020, Austria
Klinik Penzing
Vienna, 1140, Austria
Krankenhaus Nord - Klinik Floridsdorf
Vienna, 1210, Austria
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400, Brazil
Beijing Cancer Hospital
Beijing, 100142, China
The First Hospital of Jilin University
Changchun, 130021, China
West China Hospital, Sichuan University
Chengdu, 610041, China
Chongqing Cancer Hospital
Chongqing, 400030, China
Fujian Cancer Hospital
Fuzhou, 350014, China
Hainan General Hospital
Haikou, 570311, China
Sir Run Run Shaw Hospital Zhejiang University
Hangzhou, 310016, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Jinan Central Hospital
Jinan, 250013, China
Meizhou People's Hospital
Meizhou, 514031, China
The 1st Affiliated Hospital of Nanchang Unversity
Nanchang, 330200, China
Nantong Tumor Hospital
Nantong, 226361, China
Zhongshan Hospital Fudan University
Shanghai, 200032, China
Fudan University Shanghai Cancer Center
Shanghai, 200120, China
Shanghai Pulmonary Hospital
Shanghai, 200433, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, 710061, China
The First Affiliated Hospital of Xiamen University
Xiamen, 361003, China
Zhejiang Cancer Hospital
Zhejiang, 310022, China
Krankenhaus Nordwest
Frankfurt, 60488, Germany
LungenClinic Großhansdorf GmbH
Großhansdorf, 22927, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH
Halle, 06120, Germany
SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein
Löwenstein, 74245, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
Münster, 48153, Germany
Klinik Schillerhöhe
Stuttgart, 70376, Germany
Sotiria Hospital
Athens, 104 31, Greece
Metropolitan Hospital
Athens, 185 47, Greece
University Hospital of Larissa
Larissa, 411 10, Greece
Orszagos Koranyi TBC es Pulmonologiai Intezet
Budapest, 1121, Hungary
Matrai Gyogyintezet
Mátraháza, 3233, Hungary
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház
Szolnok, 5004, Hungary
Azienda Ospedaliera San Giuseppe Moscati
Avellino, Campania, 83100, Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Naples, Campania, 80131, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, 00151, Italy
Policlinico Universitario "Agostino Gemelli"
Rome, Lazio, 00168, Italy
Irccs Istituto Europeo di Oncologia (IEO)
Milan, Lombardy, 20141, Italy
Asst Di Monza
Monza, Lombardy, 20900, Italy
Istituto Clinico Humanitas
Rozzano, Lombardy, 20089, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Orbassano, Piedmont, 10043, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
Perugia, Umbria, 06156, Italy
IOV - Istituto Oncologico Veneto - IRCCS
Padua, Veneto, 35128, Italy
Aichi Cancer Center
Aichi, 464-8681, Japan
National Cancer Center Hospital East
Chiba, 277-8577, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Sendai Kousei Hospital
Miyagi, 980-0873, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Osaka International Cancer Institute
Osaka, 541-8567, Japan
Kindai University Hospital
Osaka, 589-8511, Japan
Saitama Cancer Center
Saitama, 362-0806, Japan
NHO Kinki-Chuo Chest Medical Center
Sakaishi, 591-8555, Japan
Shizuoka Cancer Center
Shizuoka, 411-8777, Japan
National Cancer Center Hospital
Tokyo, 104-0045, Japan
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550, Japan
Health Pharma Professional Research
CD Mexico, Mexico CITY (federal District), 03810, Mexico
Cryptex Investigacion Clinica SA de CV
México, Mexico CITY (federal District), 06100, Mexico
AVIX Investigación Clínica S.C
Monterrey, Nuevo León, 64710, Mexico
Cuidados oncologicos
Querétaro City, Querétaro, 76000, Mexico
Ziekenhuis Gelderse Vallei
Ede, 6716 RP, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, 8934 AD, Netherlands
Hagaziekenhuis, locatie Leyweg
The Hague, 2545 AA, Netherlands
Instituto Regional de Enfermedades Neoplásicas del Sur
Arequipa, 5154, Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima, 15038, Peru
Clinica Internacional, Sede San Borja
Lima, Lima 41, Peru
Clinica Ricardo Palma
San Isidro, Lima 27, Peru
Uniwersyteckie Centrum Kliniczne
Gda?sk, 80-214, Poland
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
Olsztyn, 10-357, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
Poznan, 60-569, Poland
Main Military Clinical Hospital named after N.N. Burdenko
Moscow, Moscow Oblast, 105229, Russia
MEDSI Clinical Hospital on Pyatnitsky Highway
Moscow, Moscow Oblast, 143422, Russia
Institute of Oncology
Saint Petersburg, Sankt-Peterburg, 189646, Russia
St. Petersburg Med Univ
Saint Petersburg, Sankt-Peterburg, 197089, Russia
St. Petersburg Clinical Scientific Center of special services medical assis (oncology)
Saint Petersburg, Sankt-Peterburg, 197758, Russia
Clinical Center of Serbia
Belgrade, 11000, Serbia
University Hospital Medical Center Bezanijska kosa
Belgrade, 11080, Serbia
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, 13620, South Korea
Ajou University Medical Center
Gyeonggi-do, 16499, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Medical Center
Seoul, 03181, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Samsung Medical Center
Seoul, 6351, South Korea
St. Vincent's Hospital
Suwon, 442-723, South Korea
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital General Universitario de Alicante
Alicante, 03010, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Madrid, 28222, Spain
Hospital Universitario Virgen del Rocío
Madrid, 41013, Spain
Hospital Regional Universitario de Malaga
Málaga, 29010, Spain
Hosp Clinico Univ Lozano Blesa
Zaragoza, 50009, Spain
Inselspital Bern
Bern, 3010, Switzerland
CHUV
Lausanne, 1011, Switzerland
HOCH Health Ostschweiz, Kantonsspital St. Gallen
Sankt Gallen, 9000, Switzerland
Chang Gung Memorial Hospital - Linkou Branch
Guishan Dist., 33305, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
Taipei Medical University ?Shuang Ho Hospital
New Taipei City, 23561, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
National Cheng Kung Uni Hospital
Tainan, 704, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
National Taiwan University Hospital
Zhongzheng Dist., 10048, Taiwan
Chulalongkorn Hospital
Bangkok, 10330, Thailand
Ramathibodi Hospital
Bangkok, 10400, Thailand
Faculty of Med. Siriraj Hosp.
Bangkok, 10700, Thailand
Songklanagarind Hospital
Songkhla, 90110, Thailand
Adana Baskent University Hospital
Adana, 01120, Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, 06100, Turkey (Türkiye)
Istanbul University Cerrahpasa Faculty of Medicine
Istanbul, 34098, Turkey (Türkiye)
Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
Izmir, 35110, Turkey (Türkiye)
Goztepe Prof.Dr. Suleyman Yalcin City Hospital
Kadiköy, 34722, Turkey (Türkiye)
Inonu University Medical Faculty of Medicine
Malatya, 44280, Turkey (Türkiye)
City Clinical Hospital #4
Dnipropetrovsk, 49102, Ukraine
ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council
Kryvyi Rih, 50048, Ukraine
Uzhgorod Nat. University Central Municip Hosp
Uzhhorod, 88000, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2020
First Posted
March 4, 2020
Study Start
March 4, 2020
Primary Completion
December 30, 2025
Study Completion
December 30, 2025
Last Updated
January 30, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing