A Study of Tiragolumab in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer (SKYSCRAPER-01)

April 11, 2024 updated by: Hoffmann-La Roche

A Phase III, Randomized, Double-Blinded, Placebo-Controlled Study of Tiragolumab, an Anti-Tigit Antibody, in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer

The purpose of the study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with previously untreated locally advanced, unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. Eligible participants will be randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

620

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Austin Hospital Olivia Newton John Cancer Centre
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre
  • Austria
      • Linz, Austria, 4020
        • Ordensklinikum Linz Elisabethinen
      • Wien, Austria, 1210
        • Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie
      • Wien, Austria, 1140
        • Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten
  • Brazil
    • RS
      • Ijui, RS, Brazil, 98700-000
        • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
    • SP
      • Barretos, SP, Brazil, 14784-400
        • Hospital de Cancer de Barretos
  • China
      • Beijing, China, 100142
        • Beijing Cancer Hospital
      • Beijing, China, 101149
        • Beijing Chest Hospital; Oncology Department
      • Changchun City, China, 130021
        • The First Hospital of Jilin University
      • Changzhou, China, 213003
        • Changzhou First People's Hospital
      • Chengdu, China, 610041
        • West China Hospital, Sichuan University
      • Chengdu City, China, 610041
        • Sichuan Cancer Hospital
      • Chongqing, China, 400030
        • Chongqing Cancer Hospital
      • Fuzhou, China, 350014
        • Fujian cancer hospital
      • Guangzhou, China, 510000
        • Cancer Center of Guangzhou Medical University
      • Haikou, China, 570311
        • Hainan General Hospital
      • Hangzhou City, China, 310016
        • Sir Run Run Shaw Hospital Zhejiang University
      • Harbin, China, 150081
        • Harbin Medical University Cancer Hospital
      • Jinan City, China, 250013
        • Jinan Central Hospital
      • Meizhou City, China, 514031
        • Meizhou People's Hospital
      • Nanchang, China, 330006
        • The Second Affiliated Hospital to Nanchang University
      • Nanchang, China, 330019
        • The 1st Affiliated Hospital of Nanchang Unversity
      • Nantong City, China, 226361
        • Nantong Tumor Hospital
      • Shanghai, China, 200433
        • Shanghai pulmonary hospital
      • Shanghai, China, 200032
        • Zhongshan Hospital Fudan University
      • Shanghai City, China, 200120
        • Fudan University Shanghai Cancer Center
      • Tianjin, China, 300060
        • Tianjin Cancer Hospital
      • Wuhan City, China, 430022
        • Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
      • Xi'an, China, 710061
        • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
      • Xiamen, China, 361003
        • The First Affiliated Hospital of Xiamen University
      • Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
  • Denmark
      • Aalborg, Denmark, 9100
        • Aalborg Universitetshospital
      • København Ø, Denmark, 2100
        • Rigshospitalet; Onkologisk Klinik
      • Roskilde, Denmark, 4000
        • Sjællands Universitetshospital, Roskilde; Klinisk Onkologisk Afdeling og Palliativ Enhed
  • Germany
      • Frankfurt, Germany, 60488
        • Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie
      • Großhansdorf, Germany, 22927
        • LungenClinic Großhansdorf GmbH; Klinische Forschung
      • Halle (Saale), Germany, 06120
        • Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin I
      • Immenhausen, Germany, 34376
        • Fachklinik für Lungenerkrankungen
      • Löwenstein, Germany, 74245
        • SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein; Onk & Pal
      • Münster, Germany, 48153
        • Gemeinschaftspraxis für Hämatologie und Onkologie
      • Stuttgart, Germany, 70376
        • Klinik Schillerhöhe; Pneumologische Onkologie
  • Greece
      • Athens, Greece, 185 47
        • Metropolitan Hospital
      • Athens, Greece, 104 31
        • Sotiria Hospital
      • Larissa, Greece, 411 10
        • University Hospital of Larissa;Department of Medical Oncology
      • Thessaloniki, Greece, 570 01
        • Diavalkaniko Hospital
  • Hungary
      • Budapest, Hungary, 1121
        • Orszagos Koranyi TBC es Pulmonologiai Intezet
      • Matrahaza, Hungary, 3233
        • Matrai Gyogyintezet
      • Szolnok, Hungary, 5004
        • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály
  • Italy
    • Campania
      • Avellino, Campania, Italy, 83100
        • Azienda Ospedaliera San Giuseppe Moscati
      • Napoli, Campania, Italy, 80131
        • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
    • Lazio
      • Roma, Lazio, Italy, 151
        • Azienda Ospedaliera San Camillo Forlanini
      • Roma, Lazio, Italy, 00168
        • Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica
    • Lombardia
      • Milano, Lombardia, Italy, 20141
        • Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia
      • Monza, Lombardia, Italy, 20900
        • Asst Di Monza
      • Rozzano, Lombardia, Italy, 20089
        • Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
    • Piemonte
      • Orbassano, Piemonte, Italy, 10043
        • Azienda Sanitaria Ospedaliera S Luigi Gonzaga; SSD Oncologia Polomonare (II PAD. IV PIANO)
    • Umbria
      • Sant'Andrea Delle Fratte (PG), Umbria, Italy, 06132
        • Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
    • Veneto
      • Padova, Veneto, Italy, 35128
        • IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
  • Japan
      • Aichi, Japan, 464-8681
        • Aichi Cancer Center
      • Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Miyagi, Japan, 981-0914
        • Sendai Kousei Hospital
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
      • Osaka, Japan, 589-8511
        • Kindai University Hospital
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute
      • Saitama, Japan, 362-0806
        • Saitama Cancer Center
      • Sakai-shi, Japan, 591-8555
        • National Hospital Organization Kinki-chuo Chest Medical Center
      • Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center
      • Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of JFCR
  • Korea, Republic of
      • Cheongju si, Korea, Republic of, 28644
        • Chungbuk National University Hospital
      • Gyeonggi-do, Korea, Republic of, 16499
        • Ajou University Medical Center
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
      • Jeollanam-do, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital
      • Seongnam-si, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 08308
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03181
        • Kangbuk Samsung Medical Center
      • Suwon, Korea, Republic of, 442-723
        • St. Vincent's Hospital
  • Mexico
    • Mexico CITY (federal District)
      • Cdmx, Mexico CITY (federal District), Mexico, 03100
        • Health Pharma Professional Research
      • Mexico, Mexico CITY (federal District), Mexico, 06100
        • Cryptex Investigacion Clinica Sa de Cv
    • Nuevo LEON
      • Monterrey, Nuevo LEON, Mexico, 64710
        • AVIX Investigación Clínica S.C
    • Queretaro
      • Querétaro, Queretaro, Mexico, 76000
        • Cuidados oncologicos
  • Netherlands
      • 'S Hertogenbosch, Netherlands, 5223 GZ
        • Jeroen Bosch Ziekenhuis
      • Den-Haag, Netherlands, 2545 AA
        • Hagaziekenhuis, locatie Leyweg
      • EDE, Netherlands, 6716 RP
        • Ziekenhuis Gelderse Vallei
      • Leeuwarden, Netherlands, 8934 AD
        • Medisch Centrum Leeuwarden
  • Peru
      • Arequipa, Peru, 5154
        • Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica
      • Lima, Peru, Lima 41
        • Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
      • Lima, Peru, Lima 34
        • Instituto Nacional de Enfermedades Neoplasicas
      • San Isidro, Peru, Lima 27
        • Clinica Ricardo Palma
  • Poland
      • Gdansk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
      • Olsztyn, Poland, 10-357
        • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
      • Otwock, Poland, 05-400
        • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
      • Poznan, Poland, 60-569
        • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
  • Russian Federation
      • Novosibirsk, Russian Federation, 630047
        • City Clinical Hospital #1
      • Yaroslavl, Russian Federation, 150040
        • Regional Clinical Oncology Hospital
    • Moskovskaja Oblast
      • Moscow, Moskovskaja Oblast, Russian Federation, 105229
        • Main Military Clinical Hospital named after N.N. Burdenko
      • Moscow, Moskovskaja Oblast, Russian Federation, 143422
        • MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy
    • Sankt Petersburg
      • ST Petersburg, Sankt Petersburg, Russian Federation, 197758
        • St. Petersburg Clinical Scientific Center of special services medical assis (oncology)
      • St Petersburg, Sankt Petersburg, Russian Federation, 194291
        • Leningrad Regional Clinical Hospital
      • St Petersburg, Sankt Petersburg, Russian Federation, 197089
        • St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research
      • St Petersburg, Sankt Petersburg, Russian Federation, 189646
        • Institute of Oncology
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Center of Serbia
      • Belgrade, Serbia, 11080
        • University Hospital Medical Center Bezanijska kosa
      • Sremska Kamenica, Serbia, 21204
        • Institute For Pulmonary Diseases of Vojvodina
  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre; Servicio de Digestivo
      • Malaga, Spain, 29010
        • Hospital Regional Universitario de Málaga
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocío
      • Zaragoza, Spain, 50009
        • Hosp Clinico Univ Lozano Blesa; División De Oncología Médica
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol
    • Madrid
      • Majadahonda, Madrid, Spain, 28220
        • Hospital Universitario Puerta de Hierro - Majadahonda
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital Bern; Universitätsklinik für Medizinische Onkologie, Klinische Forschungseinheit
      • Lausanne, Switzerland, 1011
        • CHUV; Departement d'Oncologie
      • St. Gallen, Switzerland, 9000
        • Kantonsspital St.Gallen Medizin Onkologie; Klinik fuer Onkologie und Haematologie
  • Taiwan
      • Kaohsiung, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
      • Kaohsiung City, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • New Taipei City, Taiwan, 23561
        • Taipei Medical University ?Shuang Ho Hospital
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital; Dept of Internal Medicine
      • Tainan, Taiwan, 704
        • National Cheng Kung Uni Hospital; Dept of Hematology and Oncology
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
      • Taipei, Taiwan
        • Chang Gung Memorial Hospital - Linkou Branch
      • Zhongzheng Dist., Taiwan, 10048
        • National Taiwan University Hospital; Oncology
  • Thailand
      • Bangkok, Thailand, 10330
        • Chulalongkorn Hospital; Medical Oncology
      • Bangkok, Thailand, 10700
        • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
      • Songkhla, Thailand, 90110
        • Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory
  • Turkey
      • Adana, Turkey, 01120
        • Adana Baskent University Hospital; Medical Oncology
      • Ankara, Turkey, 06100
        • Hacettepe University Medical Faculty
      • Istanbul, Turkey, 34098
        • Istanbul University Cerrahpasa Faculty of Medicine
      • Izmir, Turkey, 35110
        • Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
      • Kadiköy, Turkey, 34722
        • Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
      • Malatya, Turkey, 44280
        • Inonu University Medical Faculty of Medicine; Medical Oncology Department
      • Seyhan, Turkey, 01140
        • Medical Park Seyhan Hospital; Oncology Department
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • City Clinical Hospital #4
      • Ivano-Frankivsk, Ukraine, 76018
        • Ivano-Frankivsk Regional Oncology Center
      • Kryvyi Rih, Ukraine, 50048
        • ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department
      • Uzhgorod, Ukraine, 88000
        • Uzhgorod Nat. University Central Municip Hosp; Onc Center
  • United States
    • Colorado
      • Littleton, Colorado, United States, 80120
        • Rocky Mountain Cancer Center - Denver
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale Cancer Center
    • Florida
      • Saint Petersburg, Florida, United States, 33705
        • SCRI Florida Cancer Specialists North; Research Office North Region.
      • Tallahassee, Florida, United States, 32308
        • SCRI Florida Cancer Specialists PAN
    • Minnesota
      • Saint Paul, Minnesota, United States, 55102
        • US oncology research at Minnesota Oncology
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • SCRI Oncology Partners
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists (Fairfax) - USOR
      • Salem, Virginia, United States, 24153
        • Onc & Hem Assoc SW Virginia
    • Washington
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists - Vancouver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Histologically or cytologically documented locally advanced or recurrent NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic Stage IV non-squamous or squamous NSCLC
  • No prior systemic treatment for metastatic NSCLC
  • High tumor tissue PD-L1 expression
  • Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
  • Adequate hematologic and end-organ function
  • For participants enrolled in the extended China enrollment phase: current resident of mainland China or Taiwan and of Chinese ancestry.

Exclusion Criteria:

  • Known mutation in the EGFR gene or an ALK fusion oncogene
  • Symptomatic, untreated, or actively progressing central nervous system metastases
  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
  • Malignancies other than NSCLC within 5 years, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
  • Severe infection within 4 weeks prior to initiation of study treatment
  • Positive test result for human immunodeficiency virus (HIV)
  • Active hepatitis B or hepatitis C
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
  • Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug elimination half-lives prior to initiation of study treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tiragolumab + Atezolizumab
Participants will receive atezolizumab followed by tiragolumab every 3 weeks (Q3W) on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity.
Drug: Atezolizumab
Atezolizumab 1200 milligrams (mg) administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.
Other Names:
  • Tecentriq
Drug: Tiragolumab
Tiragolumab 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Other Names:
  • MTIG7192A
Placebo Comparator: Placebo + Atezolizumab
Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity.
Drug: Atezolizumab
Atezolizumab 1200 milligrams (mg) administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.
Other Names:
  • Tecentriq
Drug: Matching Placebo
Matching Placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Investigator-Assessed Progression-Free Survival (PFS) in the Primary Analysis Set
Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
Overall Survival (OS) in the Primary Analysis Set
Time Frame: From randomization to death from any cause (up to approximately 59 months)
From randomization to death from any cause (up to approximately 59 months)
Percentage of Participants With Adverse Events (AEs)
Time Frame: Up to approximately 59 months
Up to approximately 59 months
Percentage of Participants With Cytokine-Release Syndrome (CRS)
Time Frame: Up to approximately 59 months
Up to approximately 59 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator-Assessed PFS in the Secondary Analysis Set
Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
OS in the Secondary Analysis Set
Time Frame: From randomization to death from any cause (up to approximately 59 months)
From randomization to death from any cause (up to approximately 59 months)
Investigator-Assessed Confirmed Objective Response Rate (ORR)
Time Frame: From randomization up to approximately 59 months
From randomization up to approximately 59 months
Investigator-Assessed Duration of Response (DOR)
Time Frame: From the first occurrence of a documented confirmed objective response to disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
From the first occurrence of a documented confirmed objective response to disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
Investigator-Assessed PFS Rates at 6 Months and 12 Months
Time Frame: 6 months, 12 months
6 months, 12 months
OS Rates at 12 Months and 24 Months
Time Frame: 12 months, 24 months
12 months, 24 months
Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score
Time Frame: From randomization until the first confirmed clinically meaningful deterioration (up to approximately 59 months)
TTCD using EORTC QLQ-C30 is an initial 10-point decrease in global health status (GHS)/quality of life (QoL) and functioning from baseline that must be held for at least two consecutive assessments or an initial clinically meaningful decrease above baseline followed by death. EORTC QLQ-C30: a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting and pain), GHS and QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) with a recall period of the previous week. Functioning items are scored on a 4-point scale: 1=Not at all to 4=Very much, with higher score indicating worse outcome. Symptom items (GHS and QoL) are scored on a 7-point scale: 1=Very poor to 7=Excellent. Scores will be linearly transformed with a minimum score of 0 and maximum score of 100. Higher score indicates better outcome.
From randomization until the first confirmed clinically meaningful deterioration (up to approximately 59 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trial, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2020

Primary Completion (Estimated)

February 21, 2025

Study Completion (Estimated)

February 21, 2025

Study Registration Dates

First Submitted

March 2, 2020

First Submitted That Met QC Criteria

March 2, 2020

First Posted (Actual)

March 4, 2020

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO41717
  • 2019-002925-31 (EudraCT Number)
  • 2022-502482-17-00 (Registry Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-Small Cell Lung Cancer

Clinical Trials on Atezolizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe