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A Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Participants With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer (SKYSCRAPER-06)

Primary Purpose

Non-small Cell Lung Cancer (NSCLC)

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tiragolumab
Atezolizumab
Pemetrexed
Carboplatin
Cisplatin
Tiragolumab Matching Placebo
Pembrolizumab
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

Key Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
  • No prior systemic treatment for metastatic non-squamous NSCLC
  • Known tumor programmed death-ligand 1 (PD-L1) status
  • Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
  • Life expectancy >= 12 weeks
  • Adequate hematologic and end-organ function
  • Negative human immunodeficiency virus (HIV) test at screening
  • Serology test negative for active hepatitis B virus or active hepatitis C virus at screening.

Key Exclusion Criteria:

  • Mutations in epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) fusion oncogene
  • Pulmonary lymphoepithelioma-like carcinoma subtype of NSCLC
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) 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
  • History of malignancy other than NSCLC within 5 years prior to randomization, with the exception of malignancies with a negligible risk of metastasis or death
  • Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
  • 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-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
  • Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
  • Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
  • Known allergy or hypersensitivity or other contraindication to any component of the chemotherapy regimen the participant may receive during the study
  • Women who are pregnant, or breastfeeding
  • Known targetable c-ROS oncogene 1 (ROS1) or BRAFV600E genomic aberration.

Sites / Locations

  • St. Bernard's Hospital, Inc. d/b/a St. Bernards Medical CenterRecruiting
  • University Of Arkansas
  • UCLA
  • Kaiser Permanente - Oakland
  • Kaiser Permanente - Roseville
  • Kaiser Permanente - Sacramento; Oncology Pharmacy
  • Kaiser Permanente - San Francisco (2238 Geary)
  • Kaiser Permanente - San Jose Medical Center
  • Kaiser Permanente - San Leandro
  • Kaiser Permanente - Santa Clara; Oncology Clinical trials
  • Kaiser Permanente - South San Francisco
  • Torrance Memorial Physician Network/Cancer Care
  • Kaiser Permanente - Vallejo
  • Kaiser Permanente - Walnut Creek
  • PIH Health Whittier Hospital; NC
  • SCRI Florida Cancer Specialists South
  • Advent Health Orlando
  • Orlando Health Inc.
  • SCRI Florida Cancer Specialists North; Research Office North Region.
  • Northwest Georgia Oncology Centers PC - Marietta
  • Fort Wayne Medical Oncology and Hematology, Inc
  • Cancer Center of Kansas
  • Baptist Health LexingtonRecruiting
  • Boston Medical Center
  • Cancer Care Specialists; Division of Clinical Research
  • Memorial Sloan Kettering Cancer Center
  • SCRI Tennessee Oncology Chattanooga
  • Ballad Health
  • Thompson Cancer Survival Center
  • Sarah Cannon Res. Inst. Onc.
  • Ballad Health Cancer Care
  • Inova Schar Cancer Institute; Inova Schar Cancer Institute Infusion Pharmacy
  • Bon Secours Mercy Health
  • Summit Cancer Centers
  • Onze Lieve Vrouwziekenhuis Aalst
  • Cliniques Universitaires St-Luc
  • Jessa ZiekenhuisRecruiting
  • CHU de LiègeRecruiting
  • CHU UCL Mont-Godinne
  • Vitaz
  • Crio - Centro Regional Integrado de OncologiaRecruiting
  • Oncocentro Belo Horizonte
  • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
  • Hospital das Clinicas - UFRGS
  • Hospital Nossa Senhora da Conceicao
  • Hospital de Cancer de Barretos
  • Instituto do Cancer do Estado de Sao Paulo - ICESP
  • Cross Cancer Institute
  • Royal Victoria Regional Health CentreRecruiting
  • Victoria Hospital - London Health Sciences CentreRecruiting
  • Lakeridge Health OshawaRecruiting
  • Sault Area Hospital; Algoma District Cancer ProgramRecruiting
  • Princess Margaret Cancer Center
  • Universite de Montreal - Hopital Maisonneuve-RosemontRecruiting
  • Beijing Cancer Hospital
  • Jilin Cancer Hospital
  • Xiangya Hospital Central South UniversityRecruiting
  • Changzhou First People's Hospital; Oncology
  • Affiliated Hospital of Chengde Medical University
  • Sichuan Cancer Hospital
  • West China Hospital - Sichuan University
  • Dongguan People's Hospital
  • Cancer Center of Guangzhou Medical University
  • Sir Run Run Shaw Hospital Zhejiang University
  • Anhui Provincial Hospital; Respiratory Department
  • Jinan Central Hospital
  • The Second People's Hospital Of Liaocheng
  • Linyishi Cancer Hospital
  • The First Affiliated Hospital to Henan University of Science and Technology
  • Pingxiang People Hospital
  • Qingdao Central Hospital; Department of Respiratory and Critical Care Medicine
  • Weifang People's Hospital
  • Hubei Cancer Hospital
  • The First Affiliated Hospital of Xian Jiao Tong UniversityRecruiting
  • The First Affiliated Hospital of Xinxiang Medical University
  • Subei People's Hospital of Jiangsu province; Respiratory
  • The First Affiliated Hospital of Zhengzhou University
  • Rigshospitalet; Onkologisk Klinik
  • Odense Universitetshospital, Onkologisk Afdeling R
  • Sjællands Universitetshospital, Roskilde; Klinisk Onkologisk Afdeling og Palliativ Enhed
  • Institut Bergonie; Pneumology
  • Hopital Nord; Pneumologie
  • Institut Curie; Oncologie Medicale
  • Hopital de Pontchaillou; Service de Pneumologie
  • CHU Strasbourg - Nouvel Hopital Civil
  • CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique
  • Helios Klinikum Emil von Behring GmbH
  • Augusta-Kranken-Anstalt gGmbH; Klinik für Hämatologie, Onkologie & Palliativmedizin
  • Klinikum Chemnitz gGmbHRecruiting
  • LungenClinic Großhansdorf GmbH
  • Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
  • St. Vincentius Kliniken KarlsruheRecruiting
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie
  • Klinikum der Philipps-Universität Marburg
  • Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie
  • Universitätsklinikum Tübingen; Innere Medizin VIII, Medizinische Onkologie und Pneumologie
  • Hong Kong United Oncology Centre
  • Queen Mary Hospital; Dept. of Clinical Oncology
  • Queen Mary Hospital; Medicine & Respiratory
  • Tuen Mun Hospital; Clinical Onc
  • Prince of Wales Hospital; Department of Clinical Onocology
  • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
  • IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A
  • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
  • Centro Di Riferimento Oncologico; Struttura Operativa Complessa Di Oncologia Medica B
  • IRCCS Istituto Regina Elena (IFO); Oncologia Medica B
  • A.O. Villa Scassi; Oncologia Medica
  • Asst Papa Giovanni XXIII; Oncologia MedicaRecruiting
  • ASST Spedali Civili di Brescia
  • Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1Recruiting
  • Kyushu University Hospital
  • Kurume University Hospital
  • Hiroshima University Hospital
  • Takarazuka City Hospital
  • University Hospital Kyoto Prefectural University of Medicine
  • Sendai Kousei Hospital
  • Osaka International Cancer Institute
  • Kansai Medical University Hospital
  • Kindai University Hospital
  • Kinki-Chuo Chest Medical Center
  • Saitama Cancer Center
  • The Cancer Institute Hospital of JFCR
  • Tokyo Medical University Hachioji Medical CenterRecruiting
  • Wakayama Medical University Hospital
  • International Cancer Institute (ICI)
  • University of Nairobi - Institute of Tropical and Infectious Diseases
  • Kosin University Gospel Hospital
  • Kyungpook National University Chilgok HospitalRecruiting
  • Chungnam National University Hospital
  • St. Vincent's Hospital
  • Samsung Changwon Hospital
  • Seoul National University Hospital
  • Kangbuk Samsung Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Seoul St Mary's Hospital
  • Health Pharma Professional Research
  • ARKE Estudios Clínicos S.A. de C.V.
  • Cuidados oncologicos
  • Oncologico PotosinoRecruiting
  • Auckland City Hospital, Cancer and Blood Research
  • Waikato Hospital - Cancer and Blood Research Trials Unit; Regional Cancer Centre
  • Palmerston North HospitalRecruiting
  • Tauranga Hospital, Clinical Trials Unit; BOP Clinical School
  • Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna
  • Szpital Morski Im. Pck; Oncology & Radiotherapy Dept
  • Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Onkologii Klinicznej
  • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
  • ICO L'Hospitalet; Servicio de oncologia medica
  • Hospital Son Llatzer; Servicio de Oncologia
  • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
  • Complejo Hospitalario Universitario Insular?Materno Infantil; Servicio de Oncologia
  • Hospital del Mar; Servicio de Oncologia
  • Hospital Clinic Barcelona; Servicio de oncologia
  • Hospital Lucus Augusti; Servicio de Oncologia
  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Hospital Universitario La Paz; Servicio de Oncologia
  • Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia
  • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
  • Kantonsspital Aarau
  • Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie
  • UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
  • Changhua Christian Hospital
  • China Medical University Hospital
  • Taipei Veterans General HospitalRecruiting
  • Vajira Hospital
  • Chulalongkorn Hospital; Medical Oncology
  • Pramongkutklao Hospital; Medicine - Medical Oncology Unit
  • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
  • Maharaj Nakorn Chiang Mai Hospital; Department of Medicine
  • Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory
  • Adana Baskent University Medical Faculty; Oncology
  • Ankara Bilkent City Hospital
  • Liv Hospital Ankara; Medical Oncology
  • Dicle University Faculty of Medicine
  • Trakya University Medical Faculty
  • Istanbul University Cerrahpasa Medical Faculty
  • Medeniyet University Goztepe Training and Research Hospital.
  • Royal Cornwall Hospital; Dept of Clinical Oncology
  • Castle Hill Hospital; The Queen's Centre for Oncology & Haematology
  • Barts & London School of Med; Medical Oncology
  • Guy'S Hospital; Oncology Unit
  • Christie Hospital Nhs Trust; Medical OncologyRecruiting
  • Nottingham City Hospital
  • New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tiragolumab+Atezolizumab+Pemetrexed+Carboplatin or Cisplatin

Placebo+Pembrolizumab+Pemetrexed+Carboplatin or Cisplatin

Arm Description

Induction treatment with tiragolumab in combination with atezolizumab plus pemetrexed and cisplatin or carboplatin will be administered to participants on Day 1 of each 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with tiragolumab in combination with atezolizumab and pemetrexed on Day 1 of each 21-day cycle.

Induction treatment with placebo in combination with pembrolizumab plus pemetrexed and cisplatin or carboplatin will be administered to participants on Day 1 of each 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with placebo in combination with pembrolizumab and pemetrexed on Day 1 of each 21-day cycle.

Outcomes

Primary Outcome Measures

Investigator-Assessed Confirmed Objective Response Rate (ORR) (Phase 2)
Investigator-Assessed Progression-Free Survival (PFS) (Phase 2 and Phase 3)
Overall Survival (Phase 3)

Secondary Outcome Measures

Overall Survival (Phase 2)
PFS as Determined by an Independent Review Facility (IRF) (Phase 3)
Investigator-assessed PFS in Participants With PD-L1 Expression at TC ≥50% and TC ≥1% Cut-off, as Determined by Central Testing With Ventana PD-L1 (SP263) Assay (Phase 3)
OS in Participants With PD-L1 Expression at TC ≥50% and TC ≥1% Cut-off, as Determined by Central Testing With Ventana PD-L1 (SP263) Assay (Phase 3)
Investigator-Assessed PFS at 6 Months and 12 Months (Phase 3)
OS Rate at 12 Months and 24 Months (Phase 3)
Investigator-Assessed Confirmed ORR (Phase 3)
Investigator-Assessed Duration of Response (DOR) (Phase 2 and Phase 3)
Time to Confirmed Deterioration (TTCD) in Participant-Reported Physical Functioning and Global Health Status (GHS)/Quality of Life (QoL) as Measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (Phase 2 and Phase 3)
TTCD using EORTC Quality-of-Life Questionnaire Core 30 (QLQ-C30) is an initial 10-point decrease in GHS and physical 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/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.
TTCD in Participant-Reported Lung Cancer Symptoms for Cough, Dyspnea, and Chest Pain, as Measured by EORTC QLQ-LC13 (Phase 2 and Phase 3)
TTCD using EORTC Quality-of-Life Questionnaire Lung Cancer Module (QLQ-LC13) is an initial 10-point increase in symptom score 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-LC13 consists of 13 lung cancer specific items and includes 11 disease-specific scales/items (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication). Each item is scored on a 4-point scale of 1=Not at all to 4=Very much. Scores will be linearly transformed to a score range of 0 to 100. Higher score indicates worsening of symptoms.
Percentage of Participants With Adverse Events (AEs) (Phase 2 and Phase 3)
Participants' Response to Side Effects of Treatment as Assessed by EORTC IL46 (Phase 2 and Phase 3)
EORTC Item List 46 (IL46) is a validated single-item question that assesses overall side effect impact. Each item is scored on a 4-point scale of 1=Not at all to 4=Very much. Scores will be linearly transformed to a score range of 0 to 100. Higher score indicates a worse outcome.
Serum Concentration of Tiragolumab (Phase 2 and Phase 3)
Serum Concentration of Atezolizumab (Phase 2 and Phase 3)
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab (Phase 2 and Phase 3)
Percentage of Participants With ADAs to Atezolizumab (Phase 2 and Phase 3)

Full Information

First Posted
October 30, 2020
Last Updated
October 5, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04619797
Brief Title
A Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Participants With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer
Acronym
SKYSCRAPER-06
Official Title
A Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Patients With Previously Untreated Advanced Non-Squamous Non-Small-Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
May 14, 2027 (Anticipated)
Study Completion Date
May 14, 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, safety, and pharmacokinetics of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B) in participants with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). Eligible participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during the induction phase: Arm A: Tiragolumab plus atezolizumab plus pemetrexed and carboplatin or cisplatin Arm B: Placebo plus pembrolizumab plus pemetrexed and carboplatin or cisplatin Following the induction phase, participants will continue maintenance therapy with either tiragolumab in combination with atezolizumab and pemetrexed (Arm A) or placebo in combination with pembrolizumab and pemetrexed (Arm B).

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 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
540 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tiragolumab+Atezolizumab+Pemetrexed+Carboplatin or Cisplatin
Arm Type
Experimental
Arm Description
Induction treatment with tiragolumab in combination with atezolizumab plus pemetrexed and cisplatin or carboplatin will be administered to participants on Day 1 of each 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with tiragolumab in combination with atezolizumab and pemetrexed on Day 1 of each 21-day cycle.
Arm Title
Placebo+Pembrolizumab+Pemetrexed+Carboplatin or Cisplatin
Arm Type
Placebo Comparator
Arm Description
Induction treatment with placebo in combination with pembrolizumab plus pemetrexed and cisplatin or carboplatin will be administered to participants on Day 1 of each 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with placebo in combination with pembrolizumab and pemetrexed on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Tiragolumab
Other Intervention Name(s)
MTIG7192A
Intervention Description
Tiragolumab at a fixed dose of 600 milligrams (mg), administered by intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq
Intervention Description
Atezolizumab at a fixed dose of 1200 mg, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Pemetrexed 500 milligrams per square meter (mg/m^2), administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin at dose of area under the concentration-time curve (AUC) of 5, administered by IV infusion, Q3W on Day 1 of each 21-day cycle for 4 cycles.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin 75 mg/m^2, administered by IV infusion, Q3W on Day 1 of each 21-day cycle for 4 cycles.
Intervention Type
Drug
Intervention Name(s)
Tiragolumab Matching Placebo
Intervention Description
Matching placebo, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Pembrolizumab at a fixed dose of 200 mg, administered by IV infusion, Q3W, on Day 1 of each 21-day cycle.
Primary Outcome Measure Information:
Title
Investigator-Assessed Confirmed Objective Response Rate (ORR) (Phase 2)
Time Frame
Up to approximately 5 years
Title
Investigator-Assessed Progression-Free Survival (PFS) (Phase 2 and Phase 3)
Time Frame
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 5 years [Phase 2], up to approximately 7 years [Phase 3])
Title
Overall Survival (Phase 3)
Time Frame
From randomization to death from any cause (up to approximately 7 years)
Secondary Outcome Measure Information:
Title
Overall Survival (Phase 2)
Time Frame
From randomization to death from any cause (up to approximately 5 years)
Title
PFS as Determined by an Independent Review Facility (IRF) (Phase 3)
Time Frame
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 7 years)
Title
Investigator-assessed PFS in Participants With PD-L1 Expression at TC ≥50% and TC ≥1% Cut-off, as Determined by Central Testing With Ventana PD-L1 (SP263) Assay (Phase 3)
Time Frame
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 7 years)
Title
OS in Participants With PD-L1 Expression at TC ≥50% and TC ≥1% Cut-off, as Determined by Central Testing With Ventana PD-L1 (SP263) Assay (Phase 3)
Time Frame
From randomization to death from any cause (up to approximately 7 years)
Title
Investigator-Assessed PFS at 6 Months and 12 Months (Phase 3)
Time Frame
6 months, 12 months
Title
OS Rate at 12 Months and 24 Months (Phase 3)
Time Frame
12 months, 24 months
Title
Investigator-Assessed Confirmed ORR (Phase 3)
Time Frame
Up to approximately 7 years
Title
Investigator-Assessed Duration of Response (DOR) (Phase 2 and Phase 3)
Time Frame
From first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 5 years [Phase 2]; up to approximately 7 years [Phase 3])
Title
Time to Confirmed Deterioration (TTCD) in Participant-Reported Physical Functioning and Global Health Status (GHS)/Quality of Life (QoL) as Measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (Phase 2 and Phase 3)
Description
TTCD using EORTC Quality-of-Life Questionnaire Core 30 (QLQ-C30) is an initial 10-point decrease in GHS and physical 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/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.
Time Frame
Up to approximately 5 years (Phase 2); up to approximately 7 years (Phase 3)
Title
TTCD in Participant-Reported Lung Cancer Symptoms for Cough, Dyspnea, and Chest Pain, as Measured by EORTC QLQ-LC13 (Phase 2 and Phase 3)
Description
TTCD using EORTC Quality-of-Life Questionnaire Lung Cancer Module (QLQ-LC13) is an initial 10-point increase in symptom score 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-LC13 consists of 13 lung cancer specific items and includes 11 disease-specific scales/items (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication). Each item is scored on a 4-point scale of 1=Not at all to 4=Very much. Scores will be linearly transformed to a score range of 0 to 100. Higher score indicates worsening of symptoms.
Time Frame
Up to approximately 5 years (Phase 2); up to approximately 7 years (Phase 3)
Title
Percentage of Participants With Adverse Events (AEs) (Phase 2 and Phase 3)
Time Frame
Up to approximately 5 years (Phase 2); up to approximately 7 years (Phase 3)
Title
Participants' Response to Side Effects of Treatment as Assessed by EORTC IL46 (Phase 2 and Phase 3)
Description
EORTC Item List 46 (IL46) is a validated single-item question that assesses overall side effect impact. Each item is scored on a 4-point scale of 1=Not at all to 4=Very much. Scores will be linearly transformed to a score range of 0 to 100. Higher score indicates a worse outcome.
Time Frame
Up to approximately 5 years (Phase 2); up to approximately 7 years (Phase 3)
Title
Serum Concentration of Tiragolumab (Phase 2 and Phase 3)
Time Frame
Cycle 1 (each cycle=21 days), Day 1: predose, 0.5 hour (h) postdose; Cycles 2, 3, 4, 8, 12, 16, Day 1: predose and at treatment discontinuation (TD) visit (up to approximately 5 years [Phase 2]; up to approximately 7 years [Phase 3])
Title
Serum Concentration of Atezolizumab (Phase 2 and Phase 3)
Time Frame
Cycle 1 (each cycle=21 days), Day 1: predose, 0.5 hour (h) postdose; Cycles 2, 3, 4, 8, 12, 16, Day 1: predose and at TD visit (up to approximately 5 years [Phase 2]; up to approximately 7 years [Phase 3])
Title
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab (Phase 2 and Phase 3)
Time Frame
Predose on Day 1 of Cycles (each cycle=21 days) 1, 2, 3, 4, 8, 12, 16 and at TD visit (up to approximately 5 years [Phase 2]; up to approximately 7 years [Phase 3])
Title
Percentage of Participants With ADAs to Atezolizumab (Phase 2 and Phase 3)
Time Frame
Predose on Day 1 of Cycles (each cycle=21 days) 1, 2, 3, 4, 8, 12, 16 and at TD visit (up to approximately 5 years [Phase 2]; up to approximately 7 years [Phase 3])

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy No prior systemic treatment for metastatic non-squamous NSCLC Known tumor programmed death-ligand 1 (PD-L1) status Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) Life expectancy >= 12 weeks Adequate hematologic and end-organ function Negative human immunodeficiency virus (HIV) test at screening Serology test negative for active hepatitis B virus or active hepatitis C virus at screening. Key Exclusion Criteria: Mutations in epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) fusion oncogene Pulmonary lymphoepithelioma-like carcinoma subtype of NSCLC Symptomatic, untreated, or actively progressing central nervous system (CNS) 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 History of malignancy other than NSCLC within 5 years prior to randomization, with the exception of malignancies with a negligible risk of metastasis or death Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety 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-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment Known allergy or hypersensitivity or other contraindication to any component of the chemotherapy regimen the participant may receive during the study Women who are pregnant, or breastfeeding Known targetable c-ROS oncogene 1 (ROS1) or BRAFV600E genomic aberration.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: BO42592 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. Only)
Email
global-roche-genentech-trials@gene.com
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
St. Bernard's Hospital, Inc. d/b/a St. Bernards Medical Center
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Individual Site Status
Recruiting
Facility Name
University Of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kaiser Permanente - Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kaiser Permanente - Roseville
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kaiser Permanente - Sacramento; Oncology Pharmacy
City
Sacramento
State/Province
California
ZIP/Postal Code
95814
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kaiser Permanente - San Francisco (2238 Geary)
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kaiser Permanente - San Jose Medical Center
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kaiser Permanente - San Leandro
City
San Leandro
State/Province
California
ZIP/Postal Code
94577
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kaiser Permanente - Santa Clara; Oncology Clinical trials
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kaiser Permanente - South San Francisco
City
South San Francisco
State/Province
California
ZIP/Postal Code
94080
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Torrance Memorial Physician Network/Cancer Care
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kaiser Permanente - Vallejo
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kaiser Permanente - Walnut Creek
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
PIH Health Whittier Hospital; NC
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
SCRI Florida Cancer Specialists South
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Individual Site Status
Completed
Facility Name
Advent Health Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Orlando Health Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
SCRI Florida Cancer Specialists North; Research Office North Region.
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Northwest Georgia Oncology Centers PC - Marietta
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Completed
Facility Name
Fort Wayne Medical Oncology and Hematology, Inc
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Individual Site Status
Completed
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Individual Site Status
Recruiting
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Cancer Care Specialists; Division of Clinical Research
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Completed
Facility Name
SCRI Tennessee Oncology Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Ballad Health
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Thompson Cancer Survival Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916-2305
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Sarah Cannon Res. Inst. Onc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Ballad Health Cancer Care
City
Bristol
State/Province
Virginia
ZIP/Postal Code
24201
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Inova Schar Cancer Institute; Inova Schar Cancer Institute Infusion Pharmacy
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Completed
Facility Name
Bon Secours Mercy Health
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Summit Cancer Centers
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Onze Lieve Vrouwziekenhuis Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU UCL Mont-Godinne
City
Mont-godinne
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Vitaz
City
Sint Niklaas
ZIP/Postal Code
9100
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Crio - Centro Regional Integrado de Oncologia
City
Fortaleza
State/Province
CE
ZIP/Postal Code
60336-232
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Oncocentro Belo Horizonte
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30360-680
Country
Brazil
Individual Site Status
Completed
Facility Name
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
City
Ijui
State/Province
RS
ZIP/Postal Code
98700-000
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital das Clinicas - UFRGS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
91350-200
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital de Cancer de Barretos
City
Barretos
State/Province
SP
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Completed
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Royal Victoria Regional Health Centre
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Victoria Hospital - London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Lakeridge Health Oshawa
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Sault Area Hospital; Algoma District Cancer Program
City
Sault Ste. Marie
State/Province
Ontario
ZIP/Postal Code
P6B 0A8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Universite de Montreal - Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Jilin Cancer Hospital
City
Changchun
ZIP/Postal Code
132013
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Xiangya Hospital Central South University
City
Changsha City
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Name
Changzhou First People's Hospital; Oncology
City
Changzhou
ZIP/Postal Code
213003
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Affiliated Hospital of Chengde Medical University
City
Chengde City
ZIP/Postal Code
067020
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Sichuan Cancer Hospital
City
Chengdu City
ZIP/Postal Code
610041
Country
China
Individual Site Status
Active, not recruiting
Facility Name
West China Hospital - Sichuan University
City
Chengdu City
ZIP/Postal Code
610047
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Dongguan People's Hospital
City
Dongguan
ZIP/Postal Code
511700
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Cancer Center of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Sir Run Run Shaw Hospital Zhejiang University
City
Hangzhou City
ZIP/Postal Code
310016
Country
China
Individual Site Status
Withdrawn
Facility Name
Anhui Provincial Hospital; Respiratory Department
City
Hefei
ZIP/Postal Code
230088
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Jinan Central Hospital
City
Jinan City
ZIP/Postal Code
250013
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Second People's Hospital Of Liaocheng
City
Liaocheng
ZIP/Postal Code
054901
Country
China
Individual Site Status
Withdrawn
Facility Name
Linyishi Cancer Hospital
City
Linyi City
ZIP/Postal Code
276034
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital to Henan University of Science and Technology
City
Luoyang City
ZIP/Postal Code
471031
Country
China
Individual Site Status
Withdrawn
Facility Name
Pingxiang People Hospital
City
Pingxiang City
ZIP/Postal Code
337000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Qingdao Central Hospital; Department of Respiratory and Critical Care Medicine
City
Qingdao City
ZIP/Postal Code
266042
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Weifang People's Hospital
City
Weifang City
ZIP/Postal Code
261041
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Hubei Cancer Hospital
City
Wuhan
ZIP/Postal Code
430079
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Xian Jiao Tong University
City
Xi'an City
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Xinxiang Medical University
City
Xinxiang City
ZIP/Postal Code
453000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Subei People's Hospital of Jiangsu province; Respiratory
City
Yangzhou City
ZIP/Postal Code
225001
Country
China
Individual Site Status
Withdrawn
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
ZIP/Postal Code
450052
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Rigshospitalet; Onkologisk Klinik
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Active, not recruiting
Facility Name
Odense Universitetshospital, Onkologisk Afdeling R
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Active, not recruiting
Facility Name
Sjællands Universitetshospital, Roskilde; Klinisk Onkologisk Afdeling og Palliativ Enhed
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Individual Site Status
Active, not recruiting
Facility Name
Institut Bergonie; Pneumology
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hopital Nord; Pneumologie
City
Marseille cedex 20
ZIP/Postal Code
13915
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Institut Curie; Oncologie Medicale
City
Paris
ZIP/Postal Code
75231
Country
France
Individual Site Status
Withdrawn
Facility Name
Hopital de Pontchaillou; Service de Pneumologie
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU Strasbourg - Nouvel Hopital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique
City
Toulouse cedex 9
ZIP/Postal Code
31100
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Helios Klinikum Emil von Behring GmbH
City
Berlin
ZIP/Postal Code
14165
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Augusta-Kranken-Anstalt gGmbH; Klinik für Hämatologie, Onkologie & Palliativmedizin
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Individual Site Status
Recruiting
Facility Name
LungenClinic Großhansdorf GmbH
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
City
Halle
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Withdrawn
Facility Name
St. Vincentius Kliniken Karlsruhe
City
Karlsruhe
ZIP/Postal Code
76137
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Klinikum der Philipps-Universität Marburg
City
Marburg
ZIP/Postal Code
35032
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Universitätsklinikum Tübingen; Innere Medizin VIII, Medizinische Onkologie und Pneumologie
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Hong Kong United Oncology Centre
City
Hong Kong
Country
Hong Kong
Individual Site Status
Active, not recruiting
Facility Name
Queen Mary Hospital; Dept. of Clinical Oncology
City
Hong Kong
Country
Hong Kong
Individual Site Status
Active, not recruiting
Facility Name
Queen Mary Hospital; Medicine & Respiratory
City
Hong Kong
Country
Hong Kong
Individual Site Status
Active, not recruiting
Facility Name
Tuen Mun Hospital; Clinical Onc
City
Hong Kong
Country
Hong Kong
Individual Site Status
Active, not recruiting
Facility Name
Prince of Wales Hospital; Department of Clinical Onocology
City
Shatin
Country
Hong Kong
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
City
Avellino
State/Province
Campania
ZIP/Postal Code
83100
Country
Italy
Individual Site Status
Withdrawn
Facility Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Completed
Facility Name
Centro Di Riferimento Oncologico; Struttura Operativa Complessa Di Oncologia Medica B
City
Aviano
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33081
Country
Italy
Individual Site Status
Completed
Facility Name
IRCCS Istituto Regina Elena (IFO); Oncologia Medica B
City
Roma
State/Province
Lazio
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Withdrawn
Facility Name
A.O. Villa Scassi; Oncologia Medica
City
Genova
State/Province
Liguria
ZIP/Postal Code
16149
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Asst Papa Giovanni XXIII; Oncologia Medica
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Spedali Civili di Brescia
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50139
Country
Italy
Individual Site Status
Recruiting
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kurume University Hospital
City
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Takarazuka City Hospital
City
Hyogo
ZIP/Postal Code
665-0827
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
University Hospital Kyoto Prefectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Sendai Kousei Hospital
City
Miyagi
ZIP/Postal Code
980-0873
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Osaka International Cancer Institute
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kansai Medical University Hospital
City
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Individual Site Status
Completed
Facility Name
Kindai University Hospital
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kinki-Chuo Chest Medical Center
City
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Saitama Cancer Center
City
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
The Cancer Institute Hospital of JFCR
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Tokyo Medical University Hachioji Medical Center
City
Tokyo
ZIP/Postal Code
193-0998
Country
Japan
Individual Site Status
Recruiting
Facility Name
Wakayama Medical University Hospital
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
International Cancer Institute (ICI)
City
Eldoret
ZIP/Postal Code
30100
Country
Kenya
Individual Site Status
Active, not recruiting
Facility Name
University of Nairobi - Institute of Tropical and Infectious Diseases
City
Nairobi
ZIP/Postal Code
19676-00202
Country
Kenya
Individual Site Status
Withdrawn
Facility Name
Kosin University Gospel Hospital
City
Busan
ZIP/Postal Code
49267
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
St. Vincent's Hospital
City
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Samsung Changwon Hospital
City
Gyeongsangnam-do
ZIP/Postal Code
51353
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Seoul St Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Health Pharma Professional Research
City
Cdmx
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
ARKE Estudios Clínicos S.A. de C.V.
City
Mexico City
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Cuidados oncologicos
City
Querétaro
State/Province
Queretaro
ZIP/Postal Code
76000
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Oncologico Potosino
City
San Luis Potosí
State/Province
SAN LUIS Potosi
ZIP/Postal Code
78209
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Auckland City Hospital, Cancer and Blood Research
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Individual Site Status
Active, not recruiting
Facility Name
Waikato Hospital - Cancer and Blood Research Trials Unit; Regional Cancer Centre
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Individual Site Status
Active, not recruiting
Facility Name
Palmerston North Hospital
City
Palmerston North
ZIP/Postal Code
4410
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Tauranga Hospital, Clinical Trials Unit; BOP Clinical School
City
Tauranga
ZIP/Postal Code
3112
Country
New Zealand
Individual Site Status
Active, not recruiting
Facility Name
Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna
City
?ód?
ZIP/Postal Code
90-338
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Szpital Morski Im. Pck; Oncology & Radiotherapy Dept
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Onkologii Klinicznej
City
Grudzi?dz
ZIP/Postal Code
86-300
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
City
Olsztyn
ZIP/Postal Code
10-357
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
ICO L'Hospitalet; Servicio de oncologia medica
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Son Llatzer; Servicio de Oncologia
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07198
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
City
A Coruña
State/Province
LA Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Complejo Hospitalario Universitario Insular?Materno Infantil; Servicio de Oncologia
City
Las Palmas de Gran Canaria
State/Province
LAS Palmas
ZIP/Postal Code
35016
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital del Mar; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Clinic Barcelona; Servicio de oncologia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Lucus Augusti; Servicio de Oncologia
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario La Paz; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Kantonsspital Aarau
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
Changhua Christian Hospital
City
Chang Hua
ZIP/Postal Code
500
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Vajira Hospital
City
Bangkok
ZIP/Postal Code
10300
Country
Thailand
Individual Site Status
Active, not recruiting
Facility Name
Chulalongkorn Hospital; Medical Oncology
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Completed
Facility Name
Pramongkutklao Hospital; Medicine - Medical Oncology Unit
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Active, not recruiting
Facility Name
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Active, not recruiting
Facility Name
Maharaj Nakorn Chiang Mai Hospital; Department of Medicine
City
ChiangMai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Active, not recruiting
Facility Name
Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Active, not recruiting
Facility Name
Adana Baskent University Medical Faculty; Oncology
City
Adana
ZIP/Postal Code
01220
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Ankara Bilkent City Hospital
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Liv Hospital Ankara; Medical Oncology
City
Ankara
ZIP/Postal Code
06680
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Dicle University Faculty of Medicine
City
Diyarbakir
ZIP/Postal Code
21280
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Trakya University Medical Faculty
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Istanbul University Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Medeniyet University Goztepe Training and Research Hospital.
City
Kadiköy
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Royal Cornwall Hospital; Dept of Clinical Oncology
City
Cornwall
ZIP/Postal Code
TR1 3LQ
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Castle Hill Hospital; The Queen's Centre for Oncology & Haematology
City
Hull
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Barts & London School of Med; Medical Oncology
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Guy'S Hospital; Oncology Unit
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Christie Hospital Nhs Trust; Medical Oncology
City
Manchester
ZIP/Postal Code
M2O 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Nottingham City Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Individual Site Status
Active, not recruiting

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/ourmember/roche/). 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 Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Participants With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer

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