A Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Participants With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)
SKYSCRAPER-03
A Phase III, Open-Label, Randomized Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Patients With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent Platinum-Based Chemoradiation
2 other identifiers
interventional
829
25 countries
174
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of atezolizumab in combination with tiragolumab compared with durvalumab in participants with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) who have received at least two cycles of concurrent platinum-based chemoradiotherapy (CRT) and have not had radiographic disease progression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2020
Longer than P75 for phase_3
174 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
August 13, 2020
CompletedFirst Posted
Study publicly available on registry
August 14, 2020
CompletedStudy Start
First participant enrolled
August 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedSeptember 8, 2025
September 1, 2025
4.8 years
August 13, 2020
September 5, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Independent Review Facility (IRF)-assessed Progression Free Survival (PFS) in the PD-L1-positive Analysis Set (PPAS)
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
IRF-assessed PFS in the Full Analysis Set (FAS)
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
Secondary Outcomes (23)
Overall Survival (OS) in the PPAS
From randomization to death from any cause (up to approximately 114 months)
Investigator-assessed PFS in the PPAS
Time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first first (up to approximately 114 months)
IRF-assessed Confirmed Objective Response Rate (ORR) in the PPAS
From randomization up to approximately 114 months
Investigator-assessed Confirmed ORR in the PPAS
From randomization up to approximately 114 months
IRF-assessed Duration of Response (DOR) in the PPAS
From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
- +18 more secondary outcomes
Study Arms (2)
Atezolizumab + Tiragolumab
EXPERIMENTALParticipants will receive atezolizumab administered intravenously (IV) on Day 1 of each 28-day cycle followed by tiragolumab administered IV on Day 1 of each 28-day cycle for a maximum of 13 cycles.
Durvalumab
ACTIVE COMPARATORParticipants will receive durvalumab administered IV during each 28-day cycle for a maximum of 13 cycles.
Interventions
Atezolizumab 1680 mg every 4 weeks (Q4W) will be administered IV on Day 1 of each 28-day cycle.
Tiragolumab 840 mg Q4W will be administered IV on Day 1 of each 28-day cycle.
Durvalumab will be administered based on weight at 10 mg/kg IV every 2 weeks (Q2W) on Days 1 and 15 of each 28-day cycle, or will be administered at a fixed dose of 1500 mg IV every 4 weeks (Q4W) (for participants whose weight \>/= 30 kg) on Day 1 of each 28-day cycle.
Eligibility Criteria
You may qualify if:
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Histologically or cytologically documented NSCLC with locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology
- Whole-body Positron Emission Tomography-Computed Tomography (PET-CT) scan, performed prior and within 42 days of the first dose of concurrent chemoradiotherapy (cCRT)
- At least two prior cycles of platinum-based chemotherapy administered concurrently with radiotherapy (RT), which must be completed within 1 to 42 days prior to randomization in the study (one cycle of cCRT is defined as 21 or 28 days)
- The radiotherapy (RT) component in the cCRT must have been at a total dose of radiation of 60 (±10 percent \[%\]) gray (Gy) (54 Gy to 66 Gy) administered by intensity modulated RT (preferred) or 3D-conforming technique
- No progression during or following concurrent platinum-based CRT
- A known PD-L1 result
- Life expectancy \>/= 12 weeks
- Adequate hematologic and end-organ function
- Female participants must be willing to avoid pregnancy for 90 days after the final dose of tiragolumab and 5 months after the final dose of atezolizumab, or for 3 months after the final dose of durvalumab
- Male participants must remain abstinent or use a condom during the treatment period and for 90 days after the final dose of tiragolumab
- Male participants must not donate sperm during the treatment period and for 90 days after the final dose of tiragolumab
You may not qualify if:
- Any history of prior NSCLC and/or any history of prior treatment for NSCLC (participants must be newly diagnosed with unresectable Stage III disease)
- NSCLC known to have a mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene
- Any evidence of Stage IV disease
- Treatment with sequential CRT for locally advanced NSCLC
- Participants with locally advanced NSCLC who have progressed during or after the definitive cCRT prior to randomization
- Any Grade \>2 unresolved toxicity from previous CRT
- Grade \>= 2 pneumonitis from prior CRT
- 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
- History of malignancy other than NSCLC within 5 years prior to screening with the exception of malignancies with a negligible risk of metastasis or death
- Prior allogeneic stem cell or solid organ transplantation
- Active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening
- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4, anti-T-cell immunoreceptor with Ig and ITIM domains (anti-TIGIT), anti-PD-1 and anti-PD-L1
- Any prior Grade \>/= 3 immune-mediated adverse event or any unresolved Grade \> 1 immune-mediated adverse event while receiving any previous immunotherapy agent other than immune checkpoint blockade agents
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (177)
Stanford University
Palo Alto, California, 94305, United States
Banner MD Anderson Cancer Center
Greeley, Colorado, 80631, United States
Florida Cancer Specialists
Fort Myers, Florida, 33901-8101, United States
Cancer Care Centers of Brevard
Palm Bay, Florida, 32901, United States
Woodlands Medical Specialists, P.A.
Pensacola, Florida, 32503, United States
Florida Cancer Specialist, North Region
St. Petersburg, Florida, 33705, United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, 30060, United States
Illinois Cancer Care
Peoria, Illinois, 61615, United States
New England Cancer Specialists
Brunswick, Maine, 04011, United States
Southcoast Health System
Fairhaven, Massachusetts, 02719, United States
Minnesota Oncology Hematology
Minneapolis, Minnesota, 55404, United States
HCA Midwest Health
Kansas City, Missouri, 64132, United States
Cox Health Systems
Springfield, Missouri, 65807, United States
Optum Health Care
Las Vegas, Nevada, 89106, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89128, United States
Titan Health Partners LLC, d/b/a Astera Cancer Care
East Brunswick, New Jersey, 08816, United States
San Juan Oncology Associates
Farmington, New Mexico, 87401, United States
New York Oncology Hematology,P.C.-Albany
Albany, New York, 12208, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Prisma Health ? Upstate
Greenville, South Carolina, 29615, United States
Tennessee Oncology Chattanooga
Chattanooga, Tennessee, 37403, United States
Sarah Cannon Research Institute / Tennessee Oncology
Nashville, Tennessee, 37203, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
CEMIC
Buenos Aires, C1431FWO, Argentina
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, C1284AEB, Argentina
Clinica Universitaria Reina Fabiola
Córdoba, X5004FHP, Argentina
Sanatorio Parque S.A.
Rosario, S2000QGB, Argentina
Blacktown Hospital
Blacktown, New South Wales, 2148, Australia
Macarthur Cancer Therapy Centre
Campbelltown, New South Wales, 2560, Australia
St George Hospital
Kogarah, New South Wales, 2217, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Monash Health Translational Precinct
Victoria, Victoria, 3168, Australia
Fiona Stanley Hospital
Bull Creek, Western Australia, 6149, Australia
Tiroler Landeskrankenanstalten Ges.M.B.H.
Innsbruck, 6020, Austria
Kepler Universitätskliniken GmbH - Med Campus III
Linz, 4020, Austria
Klinik Penzing
Vienna, 1140, Austria
GHdC Site Les Viviers
Charleroi, 6000, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500, Belgium
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, 60336-550, Brazil
Centro Integrado de Oncologia de Curitiba
Curitiba, Paraná, 80810-050, Brazil
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, 01246-000, Brazil
BC Cancer ? Abbotsford
Abbotsford, British Columbia, V2S 0C2, Canada
BC Cancer - Victoria
Victoria, British Columbia, V8R 6V5, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2, Canada
William Osler Health System Brampton Civic Hospital
Brampton, Ontario, L6R 3J7, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6, Canada
Beijing Cancer Center
Beijing, 100142, China
Beijing Chest Hospital
Beijing, 101149, China
Xiangya Hospital Central South University
Changsha, 410008, China
Sichuan Provincial Cancer Hospital
Chengdu, 610041, China
Chongqing Cancer Hospital
Chongqing, 400030, China
Fujian Medical University Union Hospital
Fujian, 350001, China
Cancer Center, Sun Yat-sen University of Medical Sciences
Guangzhou, 510060, China
Hangzhou Cancer Hospital
Hangzhou, 310002, China
Shandong Cancer Hospital
Jinan, 250117, China
Zhongda Hospital Affiliated to Southeast University
Nanjing, 210009, China
The affiliated hospital of Qingdao university
Qingdao, 266042, China
Shanghai Chest Hospital
Shanghai, 200000, China
Cancer Hospital of Shantou University Medical College
Shantou, 515041, China
Shanxi Provincial Cancer Hospital
Taiyuan, 030013, China
Tianjin Cancer Hospital
Tianjin, 300060, China
The 2nd School of Medicine, WMU
Wenzhou, 325000, China
The First Affiliated Hospital of Xiamen University
Xiamen, 361003, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, 221000, China
Henan Cancer Hospital
Zhengzhou, 450008, China
CHU Angers
Angers, 49933, France
Centre Francois Baclesse
Caen, 14000, France
Hopital Nord AP-HM
Marseille, 13015, France
Clinique Clémentville
Montpellier, 34070, France
Hopital Robert Schuman
Vantoux, 57070, France
Institut Gustave Roussy
Villejuif, 94805, France
Klinikum Braunschweig
Braunschweig, 38114, Germany
Klinikum Koeln-Merheim
Cologne, 51109, Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg, 69126, Germany
Universitätsklinikum Regensburg
Regensburg, 93053, Germany
General Hospital "G.Papanikolaou"
Asvestochóri, 570 10, Greece
Sotiria Hospital
Athens, 11527, Greece
Agioi Anargyroi Cancer Hospital
Kifissia, 145 64, Greece
Princess Margaret Hospital, Oncology
Hong Kong, DUMMY_VALUE, Hong Kong
Queen Elizabeth Hospital
Hong Kong, DUMMY_VALUE, Hong Kong
Pamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong
Tuen Mun Hospital
Hong Kong, Hong Kong
Pécsi Tudományegyetem
Pécs, 7623, Hungary
Szent Borbala Korhaz
Tatabánya, 2800, Hungary
Tudogyogyintezet Torokbalint
Törökbálint, 2045, Hungary
Soroka Medical Center
Beersheba, 8410100, Israel
Rambam Medical Center
Haifa, 3109601, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Napoli, Campania, 80131, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
Meldola, Emilia-Romagna, 47014, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, Emilia-Romagna, 43100, Italy
Policlinico Universitario Campus Biomedico
Rome, Lazio, 00128, Italy
IRCCS Istituto Regina Elena (IFO)
Rome, Lazio, 00144, Italy
IRCCS AOU San Martino - IST
Genoa, Liguria, 16132, Italy
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
Brescia, Lombardy, 25123, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
Milan, Lombardy, DUMMY_VALUE, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, 27100, Italy
Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello
Pisa, Tuscany, 56124, Italy
Azienda ULSS 8 Berica
Vicenza, Veneto, 36100, Italy
Aichi Cancer Center
Aichi, 464-8681, Japan
National Cancer Center East
Chiba, 277-8577, Japan
National Hospital Organization Himeji Medical Center
Hyōgo, 670-8520, Japan
Kitasato University Hospital
Kanagawa, 252-0375, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
Sendai Kousei Hospital
Miyagi, 981-0914, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Kindai University Hospital
Osaka, 589-8511, Japan
Saitama Cancer Center
Saitama, 362-0806, 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
Wakayama Medical University Hospital
Wakayama, 641-8510, Japan
Meander Medisch Centrum
Amersfoort, 3813 TZ, Netherlands
Amphia Ziekenhuis
Breda, 4819 EV, Netherlands
Medisch Centrum Haaglanden, locatie Antoniushove
Leidschendam, 2262 BA, Netherlands
Zuyderland Medisch Centrum - Sittard Geleen
Sittard-Geleen, 6162 BG, Netherlands
Auckland City Hospital, Cancer and Blood Research
Auckland, 1023, New Zealand
Uniwersyteckie Centrum Kliniczne
Gda?sk, 80-214, Poland
Szpital Kliniczny MSWiA z Warmi?sko-Mazurskim Centrum Onkologii
Olsztyn, 10-228, Poland
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
Otwock, 05-400, Poland
Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
Warsaw, 02-781, Poland
Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
Wroc?aw, 53-413, Poland
IPO de Coimbra
Coimbra, 3000-075, Portugal
Hospital da Luz
Lisbon, 1500-650, Portugal
Hospital CUF Porto
Porto, 4100-180, Portugal
IPO do Porto
Porto, 4200-072, Portugal
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
National Cancer Center
Gyeonggi-do, 10408, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, 13620, South Korea
St. Vincent's Hospital
Gyeonggi-do, 16247, South Korea
Ajou University Medical Center
Gyeonggi-do, 16499, South Korea
Pusan National University Yangsan Hospital
Gyeongsangnam-do, 50612, 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
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Ulsan University Hosiptal
Ulsan, 44033, South Korea
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, 07198, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Provincial de Castellon
Castellon, Castellon, 12002, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, 15006, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28009, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Regional Universitario Carlos Haya
Málaga, 29010, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
China Medical University Hospital
Taichung, 40447, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Vajira Hospital
Bangkok, 10300, Thailand
Rajavithi Hospital
Bangkok, 10400, Thailand
Ramathibodi Hospital;Medicine/Oncology
Bangkok, 10400, Thailand
Songklanagarind Hospital
Songkhla, 90110, Thailand
Adana Baskent University Medical Faculty
Adana, 01220, Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, 06100, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, 06100, Turkey (Türkiye)
Gazi University Medical Faculty, Oncology Hospital
Ankara, 06500, Turkey (Türkiye)
Ege University Medical Faculty
Bornova, ?zm?r, 35100, Turkey (Türkiye)
Dicle University Faculty of Medicine
Diyarbakır, 21280, Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne, 22030, Turkey (Türkiye)
Istanbul University Cerrahpasa Faculty of Medicine
Istanbul, 34098, Turkey (Türkiye)
Medipol University Medical Faculty
Istanbul, 34214, Turkey (Türkiye)
Inonu University Faculty of Medicine Turgut Ozal Medical Center
Malatya, 44280, Turkey (Türkiye)
Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
Addenbrooke's NHS Trust
Cambridge, CB2 0QQ, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
Christie Foundation Trust
Manchester, M20 4BX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2020
First Posted
August 14, 2020
Study Start
August 24, 2020
Primary Completion
May 27, 2025
Study Completion
July 31, 2025
Last Updated
September 8, 2025
Record last verified: 2025-09
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