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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)

Primary Purpose

Non-small Cell Lung Cancer (NSCLC)

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atezolizumab
Tiragolumab
Durvalumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Treatment with systemic immunosuppressive medication
  • Women who are pregnant, or breastfeeding

Sites / Locations

  • Arizona Clinical Research Center, Inc
  • Genesis Cancer and Blood Institute
  • Stanford University
  • Banner MD Anderson Cancer Center
  • Florida Cancer Specialists; Department of Oncology
  • Woodlands Medical Specialists, P.A.
  • Cancer Care Centers of Brevard
  • Florida Cancer Specialist, North Region
  • Northwest Georgia Oncology Centers PC - Marietta
  • Illinois Cancer Care
  • New England Cancer Specialists
  • Southcoast Health System
  • Minnesota Oncology Hematology
  • HCA Midwest Health
  • Cox Health Systems
  • Optum Health Care
  • Comprehensive Cancer Centers of Nevada
  • Titan Health Partners LLC, d/b/a Astera Cancer Care
  • San Juan Oncology Associates
  • New York Oncology Hematology,P.C.-Albany
  • Montefiore Medical Center
  • Mount Sinai Medical Center
  • Prisma Health ? Upstate
  • Tennessee Oncology Chattanooga
  • Tennessee Oncology; Sarah Cannon Research Institute
  • Virginia Cancer Specialists
  • Virginia Oncology Associates
  • Cemic; Oncologia Clinica
  • Hospital Britanico de Buenos Aires
  • Clinica Universitaria Reina Fabiola
  • Sanatorio Parque S.A.
  • Blacktown Hospital
  • Macarthur Cancer Therapy Centre
  • St George Hospital; Cancer Care Centre
  • Princess Alexandra Hospital
  • Flinders Medical Centre
  • Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit
  • Monash Health Translational Precinct; Clinical Trials Centre, Level 3
  • Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
  • Landesklinikum Krems
  • Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Lungenkrankheiten
  • Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten
  • GHdC Site Notre Dame
  • AZ Maria Middelares
  • Jessa Zkh (Campus Virga Jesse)
  • CHU Ambroise Paré
  • Hospital Sao Rafael - HSR
  • Crio - Centro Regional Integrado de Oncologia
  • Centro Integrado de Oncologia de Curitiba
  • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
  • Hospital Sao Lucas - PUCRS
  • Hospital de Cancer de Barretos
  • Hospital de Base de Sao Jose do Rio Preto
  • Instituto do Cancer do Estado de Sao Paulo - ICESP
  • BC Cancer ? Abbotsford
  • BC Cancer ? Surrey
  • BC Cancer - Victoria
  • Cancer Care Manitoba
  • Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials
  • William Osler Health System Brampton Civic Hospital
  • Ottawa Hospital Research Institute
  • Health Sciences North
  • Timmins and District Hospital
  • Peking Union Medical College Hospital
  • Beijing Cancer Center; Renal Cancer And Melanoma Department.
  • Beijing Chest Hospital; Oncology Department
  • Jilin Cancer Hospital
  • Xiangya Hospital Central South University
  • Changzhou Cancer hospital
  • Sichuan Provincial Cancer Hospital
  • Chongqing Cancer Hospital
  • Fujian Medical University Union Hospital
  • Fujian Provincial Cancer Hospital
  • Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology
  • Hangzhou Cancer Hospital
  • Sir Run Run Shaw Hospital Zhejiang University
  • Shandong Cancer Hospital
  • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
  • Zhongda Hospital Affiliated to Southeast University
  • Qingdao Central Hospital
  • Shanghai Chest Hospital
  • Shanghai Pulmonary Hospital
  • Cancer Hospital of Shantou University Medical College
  • Shanxi Provincial Cancer Hospital
  • Tianjin Cancer Hospital
  • The 2nd School of Medicine, WMU
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Hubei Cancer Hospital
  • The First Affiliated Hospital of Xiamen University
  • The Affiliated Hospital of Xuzhou Medical College
  • Henan Cancer Hospital
  • CHU Amiens - Hopital Sud
  • CHU Angers
  • CENTRE FRANCOIS BACLESSE; Oncologie- Pneumologie
  • Hopital Nord AP-HM
  • Clinique Clémentville
  • Hopital Robert Schuman; Pneumologie
  • Institut Gustave Roussy; Pathologie Thoracique
  • Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie
  • Universitaetsmedizin Goettingen; Abteilung Haematologie und Onkologie
  • Thoraxklinik Heidelberg gGmbH
  • Klinikum Koeln-Merheim; Lungenklinik
  • Klinikum Bogenhausen; Klinik für Pneumologie und Pneumologische Onkologie
  • Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie
  • General Hospital "G.Papanikolaou"; Pulmonogy Clinic
  • Sotiria Hospital
  • Univ General Hosp Heraklion; Medical Oncology
  • Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
  • Pamela Youde Nethersole Eastern Hospital; Clinical Oncology
  • Princess Margaret Hospital, Oncology; Department of Oncology
  • Queen Elizabeth Hospital; Clinical Oncology
  • Tuen Mun Hospital; Clinical Onc
  • Queen Mary Hospital
  • Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
  • Szent Borbala Korhaz
  • Tudogyogyintezet Torokbalint
  • Soroka Medical Center; Oncology Dept
  • Rambam Medical Center; Oncology
  • Shaare Zedek Medical Center; Oncology Dept
  • Rabin Medical Center; Oncology Dept
  • Chaim Sheba Medical Center; Oncology Dept
  • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
  • Azienda Ospedaliero Universitaria di Parma
  • Policlinico Universitario Campus Biomedico; U.O.C. di Radioterapia Oncologica
  • IRCCS Istituto Regina Elena (IFO); Oncologia Medica B
  • IRCCS AOU San Martino - IST
  • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili; U.O. Radioterapia
  • Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
  • Fondazione IRCCS Policlinico San Matteo
  • Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare
  • Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza
  • Aichi Cancer Center
  • National Cancer Center East
  • National Hospital Organization Himeji Medical Center
  • Kitasato University Hospital
  • Kyoto University Hospital
  • Sendai Kousei Hospital
  • Niigata Cancer Center Hospital
  • Kindai University Hospital
  • Saitama Cancer Center
  • Shizuoka Cancer Center
  • National Cancer Center Hospital
  • The Cancer Institute Hospital of JFCR
  • Wakayama Medical University Hospital
  • Chungbuk National University Hospital
  • Kyungpook National University Chilgok Hospital
  • National Cancer Center
  • St. Vincent's Hospital
  • Ajou University Medical Center
  • Pusan National University Yangsan Hospital
  • Gachon University Gil Medical Center
  • Chonnam National University Hwasun Hospital
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Asan Medical Center
  • Seoul St Mary's Hospital
  • Korea University Guro Hospital
  • Samsung Medical Center
  • Ulsan University Hosiptal
  • Meander Medisch Centrum
  • Amphia Ziekenhuis
  • Medisch Centrum Haaglanden, locatie Antoniushove
  • Zuyderland Medisch Centrum - Sittard Geleen
  • Auckland City Hospital, Cancer and Blood Research
  • Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
  • ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii;Wojska Polskiego 37
  • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
  • Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers
  • Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii; Oddz. Onkologii Klin. i Chemioterapii
  • IPO de Coimbra; Servico de Oncologia Medica
  • Hospital da Luz; Departamento de Oncologia Medica
  • Hospital CUF Porto; Servico Pneumologia
  • IPO do Porto; Servico de Oncologia Medica
  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
  • Hospital Provincial de Castellon; Servicio de Oncologia
  • Hospital Son Llatzer; Servicio de Oncologia
  • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
  • Hospital Universitari Vall d'Hebron; Oncology
  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Hospital Universitario La Paz; Servicio de Oncologia
  • Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  • Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia
  • China Medical University Hospital; Pulmonary and Critical Care Medicine
  • Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
  • Vajira Hospital
  • Rajavithi Hospital; Division of Medical Oncology
  • Ramathibodi Hospital; Medicine/Oncology; Clinical Research Center
  • Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory
  • Adana Baskent University Medical Faculty; Oncology
  • Ankara University Medical Faculty; Medikal Onkoloji
  • Hacettepe Universitesi Tip Fakultesi Hastanesi
  • Ankara Bilkent City Hospital
  • Gazi University Medical Faculty, Oncology Hospital
  • Ege University Medical Faculty; Medical Oncology Department
  • Dicle University Faculty of Medicine
  • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
  • Istanbul University Cerrahpasa Faculty of Medicine
  • Medipol University Medical Faculty; Oncology Department
  • Inonu University Faculty of Medicine Turgut Ozal Medical Center; Onkoloji, Elazig Yolu,
  • Birmingham Heartlands Hospital
  • Addenbrooke's NHS Trust
  • Beatson West of Scotland Cancer Centre
  • Calderdale & Huddersfield Nhs Trust; Oncology
  • Leicester Royal Infirmary; Oncology Department
  • Royal Free Hospital
  • Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
  • Christie Foundation Trust
  • Nottingham City Hospital
  • Weston Park Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Atezolizumab + Tiragolumab

Durvalumab

Arm Description

Participants 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.

Participants will receive durvalumab administered IV during each 28-day cycle for a maximum of 13 cycles.

Outcomes

Primary Outcome Measures

Independent Review Facility (IRF)-assessed Progression Free Survival (PFS) in the Full Analysis Set (FAS)
IRF-assessed PFS in the PD-L1-positive Analysis Set (PPAS)

Secondary Outcome Measures

Overall Survival (OS) in the FAS
Investigator-assessed PFS in the FAS
IRF-assessed Confirmed Objective Response Rate (ORR) in the FAS
Investigator-assessed Confirmed ORR in the FAS
IRF-assessed Duration of Response (DOR) in the FAS
Investigator-assessed DOR in the FAS
Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score in the FAS
TTCD using EORTC QLQ-C30 is an initial 10-point decrease in global health status (GHS) and physical functioning from baseline that must be held for all subsequent assessment timepoints or followed by death attributable to cancer progression. 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 quality of life (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.
OS in the PPAS
Investigator-assessed PFS in the PPAS
IRF-assessed Confirmed ORR in the PPAS
Investigator-assessed Confirmed ORR in the PPAS
IRF-assessed DOR in the PPAS
Investigator-assessed DOR in the PPAS
Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score in the PPAS
TTCD using EORTC QLQ-C30 is an initial 10-point decrease in global health status (GHS) and physical functioning from baseline that must be held for all subsequent assessment timepoints or followed by death attributable to cancer progression. 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 quality of life (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.
IRF-assessed PFS Rates at 12 Months, 18 Months and 24 Months
Investigator-assessed PFS Rates at 12 Months, 18 Months and 24 Months
OS Rates at 12 Months, 24 Months, 36 Months and 48 Months
Investigator-assessed Time to Death or Distant Metastasis (TTDM)
Percentage of Participants With Adverse Events

Full Information

First Posted
August 13, 2020
Last Updated
August 16, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04513925
Brief Title
A Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Participants With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)
Acronym
SKYSCRAPER-03
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 24, 2020 (Actual)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
December 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer (NSCLC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
829 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atezolizumab + Tiragolumab
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Durvalumab
Arm Type
Active Comparator
Arm Description
Participants will receive durvalumab administered IV during each 28-day cycle for a maximum of 13 cycles.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq; RO5541267
Intervention Description
Atezolizumab 1680 mg every 4 weeks (Q4W) will be administered IV on Day 1 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Tiragolumab
Other Intervention Name(s)
MTIG7192A; RO7092284
Intervention Description
Tiragolumab 840 mg Q4W will be administered IV on Day 1 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Independent Review Facility (IRF)-assessed Progression Free Survival (PFS) in the Full Analysis Set (FAS)
Time Frame
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 90 months)
Title
IRF-assessed PFS in the PD-L1-positive Analysis Set (PPAS)
Time Frame
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 90 months)
Secondary Outcome Measure Information:
Title
Overall Survival (OS) in the FAS
Time Frame
From randomization to death from any cause (up to approximately 90 months)
Title
Investigator-assessed PFS in the FAS
Time Frame
Time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first first (up to approximately 90 months)
Title
IRF-assessed Confirmed Objective Response Rate (ORR) in the FAS
Time Frame
From randomization up to approximately 90 months
Title
Investigator-assessed Confirmed ORR in the FAS
Time Frame
From randomization up to approximately 90 months
Title
IRF-assessed Duration of Response (DOR) in the FAS
Time Frame
From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 90 months)
Title
Investigator-assessed DOR in the FAS
Time Frame
From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 90 months)
Title
Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score in the FAS
Description
TTCD using EORTC QLQ-C30 is an initial 10-point decrease in global health status (GHS) and physical functioning from baseline that must be held for all subsequent assessment timepoints or followed by death attributable to cancer progression. 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 quality of life (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.
Time Frame
Up to approximately 90 months
Title
OS in the PPAS
Time Frame
From randomization to death from any cause (up to approximately 90 months)
Title
Investigator-assessed PFS in the PPAS
Time Frame
Time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first first (up to approximately 90 months)
Title
IRF-assessed Confirmed ORR in the PPAS
Time Frame
From randomization up to approximately 90 months
Title
Investigator-assessed Confirmed ORR in the PPAS
Time Frame
From randomization up to approximately 90 months
Title
IRF-assessed DOR in the PPAS
Time Frame
From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 90 months)
Title
Investigator-assessed DOR in the PPAS
Time Frame
From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 90 months)
Title
Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score in the PPAS
Description
TTCD using EORTC QLQ-C30 is an initial 10-point decrease in global health status (GHS) and physical functioning from baseline that must be held for all subsequent assessment timepoints or followed by death attributable to cancer progression. 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 quality of life (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.
Time Frame
Up to approximately 90 months
Title
IRF-assessed PFS Rates at 12 Months, 18 Months and 24 Months
Time Frame
12, 18 and 24 months
Title
Investigator-assessed PFS Rates at 12 Months, 18 Months and 24 Months
Time Frame
12, 18 and 24 months
Title
OS Rates at 12 Months, 24 Months, 36 Months and 48 Months
Time Frame
12, 24, 36 and 48 months
Title
Investigator-assessed Time to Death or Distant Metastasis (TTDM)
Time Frame
From randomization until the first date of distant metastasis or death in the absence of distant metastasis (up to approximately 90 months)
Title
Percentage of Participants With Adverse Events
Time Frame
Up to approximately 90 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Treatment with systemic immunosuppressive medication Women who are pregnant, or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Clinical Research Center, Inc
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Genesis Cancer and Blood Institute
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Banner MD Anderson Cancer Center
City
Greeley
State/Province
Colorado
ZIP/Postal Code
85234
Country
United States
Facility Name
Florida Cancer Specialists; Department of Oncology
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901-8101
Country
United States
Facility Name
Woodlands Medical Specialists, P.A.
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Cancer Care Centers of Brevard
City
Rockledge
State/Province
Florida
ZIP/Postal Code
32955
Country
United States
Facility Name
Florida Cancer Specialist, North Region
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Northwest Georgia Oncology Centers PC - Marietta
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Illinois Cancer Care
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
New England Cancer Specialists
City
Brunswick
State/Province
Maine
ZIP/Postal Code
04011
Country
United States
Facility Name
Southcoast Health System
City
Fairhaven
State/Province
Massachusetts
ZIP/Postal Code
02719
Country
United States
Facility Name
Minnesota Oncology Hematology
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
HCA Midwest Health
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Cox Health Systems
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Optum Health Care
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Titan Health Partners LLC, d/b/a Astera Cancer Care
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Facility Name
San Juan Oncology Associates
City
Farmington
State/Province
New Mexico
ZIP/Postal Code
87401
Country
United States
Facility Name
New York Oncology Hematology,P.C.-Albany
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Prisma Health ? Upstate
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Tennessee Oncology Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Tennessee Oncology; Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Cemic; Oncologia Clinica
City
Buenos Aires
ZIP/Postal Code
C1431FWN
Country
Argentina
Facility Name
Hospital Britanico de Buenos Aires
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1284AEB
Country
Argentina
Facility Name
Clinica Universitaria Reina Fabiola
City
Cordoba
ZIP/Postal Code
X5004FHP
Country
Argentina
Facility Name
Sanatorio Parque S.A.
City
Rosario
ZIP/Postal Code
S2000QGB
Country
Argentina
Facility Name
Blacktown Hospital
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Facility Name
Macarthur Cancer Therapy Centre
City
Campbelltown
State/Province
New South Wales
ZIP/Postal Code
2560
Country
Australia
Facility Name
St George Hospital; Cancer Care Centre
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit
City
Bull Creek
State/Province
Western Australia
ZIP/Postal Code
6149
Country
Australia
Facility Name
Monash Health Translational Precinct; Clinical Trials Centre, Level 3
City
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Landesklinikum Krems
City
Krems
ZIP/Postal Code
3500
Country
Austria
Facility Name
Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Lungenkrankheiten
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
GHdC Site Notre Dame
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
AZ Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Jessa Zkh (Campus Virga Jesse)
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
CHU Ambroise Paré
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
Hospital Sao Rafael - HSR
City
Salvador
State/Province
BA
ZIP/Postal Code
41253-190
Country
Brazil
Facility Name
Crio - Centro Regional Integrado de Oncologia
City
Fortaleza
State/Province
CE
ZIP/Postal Code
60336-232
Country
Brazil
Facility Name
Centro Integrado de Oncologia de Curitiba
City
Curitiba
State/Province
PR
ZIP/Postal Code
80810-050
Country
Brazil
Facility Name
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
City
Ijui
State/Province
RS
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Hospital de Cancer de Barretos
City
Barretos
State/Province
SP
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Hospital de Base de Sao Jose do Rio Preto
City
Sao Jose do Rio Preto
State/Province
SP
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
BC Cancer ? Abbotsford
City
Abbotsford
State/Province
British Columbia
ZIP/Postal Code
V2S 0C2
Country
Canada
Facility Name
BC Cancer ? Surrey
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
BC Cancer - Victoria
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
Facility Name
Cancer Care Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
William Osler Health System Brampton Civic Hospital
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Health Sciences North
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Timmins and District Hospital
City
Timmins
State/Province
Ontario
ZIP/Postal Code
P4N 8P2
Country
Canada
Facility Name
Peking Union Medical College Hospital
City
Beijing City
ZIP/Postal Code
100032
Country
China
Facility Name
Beijing Cancer Center; Renal Cancer And Melanoma Department.
City
Beijing City
ZIP/Postal Code
100142
Country
China
Facility Name
Beijing Chest Hospital; Oncology Department
City
Beijing
ZIP/Postal Code
101149
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
ZIP/Postal Code
132013
Country
China
Facility Name
Xiangya Hospital Central South University
City
Changsha City
ZIP/Postal Code
410008
Country
China
Facility Name
Changzhou Cancer hospital
City
Changzhou
ZIP/Postal Code
213000
Country
China
Facility Name
Sichuan Provincial Cancer Hospital
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Chongqing Cancer Hospital
City
Chongqing
ZIP/Postal Code
400030
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou City
ZIP/Postal Code
350001
Country
China
Facility Name
Fujian Provincial Cancer Hospital
City
Fuzhou City
ZIP/Postal Code
350014
Country
China
Facility Name
Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology
City
Guangzhou City
ZIP/Postal Code
510060
Country
China
Facility Name
Hangzhou Cancer Hospital
City
Hangzhou City
ZIP/Postal Code
310002
Country
China
Facility Name
Sir Run Run Shaw Hospital Zhejiang University
City
Hangzhou City
ZIP/Postal Code
310016
Country
China
Facility Name
Shandong Cancer Hospital
City
Jinan
ZIP/Postal Code
250117
Country
China
Facility Name
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
City
Nanjing City
ZIP/Postal Code
210029
Country
China
Facility Name
Zhongda Hospital Affiliated to Southeast University
City
Nanjing
ZIP/Postal Code
210009
Country
China
Facility Name
Qingdao Central Hospital
City
Qingdao City
ZIP/Postal Code
266042
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Cancer Hospital of Shantou University Medical College
City
Shantou
ZIP/Postal Code
515041
Country
China
Facility Name
Shanxi Provincial Cancer Hospital
City
Taiyuan
ZIP/Postal Code
030013
Country
China
Facility Name
Tianjin Cancer Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
The 2nd School of Medicine, WMU
City
Wenzhou City
ZIP/Postal Code
325000
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan City
ZIP/Postal Code
430022
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
ZIP/Postal Code
430079
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
ZIP/Postal Code
361003
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical College
City
Xuzhou
ZIP/Postal Code
221000
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Facility Name
CHU Amiens - Hopital Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
CENTRE FRANCOIS BACLESSE; Oncologie- Pneumologie
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Hopital Nord AP-HM
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
Clinique Clémentville
City
Montpellier
ZIP/Postal Code
34070
Country
France
Facility Name
Hopital Robert Schuman; Pneumologie
City
Vantoux
ZIP/Postal Code
57070
Country
France
Facility Name
Institut Gustave Roussy; Pathologie Thoracique
City
Villejuif cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie
City
Braunschweig
ZIP/Postal Code
38114
Country
Germany
Facility Name
Universitaetsmedizin Goettingen; Abteilung Haematologie und Onkologie
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Thoraxklinik Heidelberg gGmbH
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Klinikum Koeln-Merheim; Lungenklinik
City
Köln
ZIP/Postal Code
51109
Country
Germany
Facility Name
Klinikum Bogenhausen; Klinik für Pneumologie und Pneumologische Onkologie
City
München
ZIP/Postal Code
81925
Country
Germany
Facility Name
Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
General Hospital "G.Papanikolaou"; Pulmonogy Clinic
City
Asvestochori
ZIP/Postal Code
570 10
Country
Greece
Facility Name
Sotiria Hospital
City
Athens
ZIP/Postal Code
104 31
Country
Greece
Facility Name
Univ General Hosp Heraklion; Medical Oncology
City
Heraklion
ZIP/Postal Code
711 10
Country
Greece
Facility Name
Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
City
Kifisia
ZIP/Postal Code
145 64
Country
Greece
Facility Name
Pamela Youde Nethersole Eastern Hospital; Clinical Oncology
City
Hong Kong
Country
Hong Kong
Facility Name
Princess Margaret Hospital, Oncology; Department of Oncology
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Elizabeth Hospital; Clinical Oncology
City
Hong Kong
Country
Hong Kong
Facility Name
Tuen Mun Hospital; Clinical Onc
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Pokfulam
Country
Hong Kong
Facility Name
Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
City
Pécs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Szent Borbala Korhaz
City
Tatabánya
ZIP/Postal Code
2800
Country
Hungary
Facility Name
Tudogyogyintezet Torokbalint
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Soroka Medical Center; Oncology Dept
City
Beer Sheva
ZIP/Postal Code
8410100
Country
Israel
Facility Name
Rambam Medical Center; Oncology
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Shaare Zedek Medical Center; Oncology Dept
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Rabin Medical Center; Oncology Dept
City
Petah Tikva
ZIP/Postal Code
4910000
Country
Israel
Facility Name
Chaim Sheba Medical Center; Oncology Dept
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Facility Name
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Parma
City
Parma
State/Province
Emilia-Romagna
ZIP/Postal Code
43126
Country
Italy
Facility Name
Policlinico Universitario Campus Biomedico; U.O.C. di Radioterapia Oncologica
City
Roma
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
Facility Name
IRCCS Istituto Regina Elena (IFO); Oncologia Medica B
City
Roma
State/Province
Lazio
ZIP/Postal Code
00144
Country
Italy
Facility Name
IRCCS AOU San Martino - IST
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili; U.O. Radioterapia
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
City
Milano
State/Province
Lombardia
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56124
Country
Italy
Facility Name
Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza
City
Vicenza
State/Province
Veneto
ZIP/Postal Code
36100
Country
Italy
Facility Name
Aichi Cancer Center
City
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
National Cancer Center East
City
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Himeji Medical Center
City
Hyogo
ZIP/Postal Code
670-8520
Country
Japan
Facility Name
Kitasato University Hospital
City
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Sendai Kousei Hospital
City
Miyagi
ZIP/Postal Code
980-0873
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Kindai University Hospital
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Saitama Cancer Center
City
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
National Cancer Center Hospital
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Wakayama Medical University Hospital
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
St. Vincent's Hospital
City
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Ajou University Medical Center
City
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Gyeongsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Seoul St Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Ulsan University Hosiptal
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
Facility Name
Meander Medisch Centrum
City
Amersfoort
ZIP/Postal Code
3813 TZ
Country
Netherlands
Facility Name
Amphia Ziekenhuis
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
Medisch Centrum Haaglanden, locatie Antoniushove
City
Leidschendam
ZIP/Postal Code
2262 BA
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum - Sittard Geleen
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Auckland City Hospital, Cancer and Blood Research
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
City
Gda?sk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii;Wojska Polskiego 37
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii; Oddz. Onkologii Klin. i Chemioterapii
City
Wroc?aw
ZIP/Postal Code
53-413
Country
Poland
Facility Name
IPO de Coimbra; Servico de Oncologia Medica
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Hospital da Luz; Departamento de Oncologia Medica
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Facility Name
Hospital CUF Porto; Servico Pneumologia
City
Porto
ZIP/Postal Code
4100-180
Country
Portugal
Facility Name
IPO do Porto; Servico de Oncologia Medica
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Provincial de Castellon; Servicio de Oncologia
City
Castellon de La Plana
State/Province
Castellon
ZIP/Postal Code
12002
Country
Spain
Facility Name
Hospital Son Llatzer; Servicio de Oncologia
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07198
Country
Spain
Facility Name
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
City
A Coruña
State/Province
LA Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron; Oncology
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
City
Malaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
China Medical University Hospital; Pulmonary and Critical Care Medicine
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Vajira Hospital
City
Bangkok
ZIP/Postal Code
10300
Country
Thailand
Facility Name
Rajavithi Hospital; Division of Medical Oncology
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Ramathibodi Hospital; Medicine/Oncology; Clinical Research Center
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Adana Baskent University Medical Faculty; Oncology
City
Adana
ZIP/Postal Code
01220
Country
Turkey
Facility Name
Ankara University Medical Faculty; Medikal Onkoloji
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Hacettepe Universitesi Tip Fakultesi Hastanesi
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Ankara Bilkent City Hospital
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Facility Name
Gazi University Medical Faculty, Oncology Hospital
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Ege University Medical Faculty; Medical Oncology Department
City
Bornova, ?zm?r
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Dicle University Faculty of Medicine
City
Diyarbakir
ZIP/Postal Code
21280
Country
Turkey
Facility Name
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Istanbul University Cerrahpasa Faculty of Medicine
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Medipol University Medical Faculty; Oncology Department
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Facility Name
Inonu University Faculty of Medicine Turgut Ozal Medical Center; Onkoloji, Elazig Yolu,
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Addenbrooke's NHS Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Calderdale & Huddersfield Nhs Trust; Oncology
City
Huddersfield
ZIP/Postal Code
HD3 3EA
Country
United Kingdom
Facility Name
Leicester Royal Infirmary; Oncology Department
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QS
Country
United Kingdom
Facility Name
Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
City
Maidstone
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Christie Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

A Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Participants With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)

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