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)

January 29, 2026 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

Completed

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 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
      • Vienna, Austria, 1140
        • Klinik Penzing
      • Vienna, Austria, 1210
        • Krankenhaus Nord - Klinik Floridsdorf
  • Brazil
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil, 98700-000
        • ONCOSITE - Centro de Pesquisa Clinica em Oncologia LTDA
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Hospital de Cancer de Barretos
  • China
      • Beijing, China, 100142
        • Beijing Cancer Hospital
      • Changchun, China, 130021
        • The First Hospital of Jilin University
      • Chengdu, China, 610041
        • West China Hospital, Sichuan University
      • Chongqing, China, 400030
        • Chongqing Cancer Hospital
      • Fuzhou, China, 350014
        • Fujian Cancer Hospital
      • Haikou, China, 570311
        • Hainan General Hospital
      • Hangzhou, China, 310016
        • Sir Run Run Shaw Hospital Zhejiang University
      • Harbin, China, 150081
        • Harbin Medical University Cancer Hospital
      • Jinan, China, 250013
        • Jinan Central Hospital
      • Meizhou, China, 514031
        • Meizhou People's Hospital
      • Nanchang, China, 330200
        • The 1st Affiliated Hospital of Nanchang Unversity
      • Nantong, China, 226361
        • Nantong Tumor Hospital
      • Shanghai, China, 200433
        • Shanghai Pulmonary Hospital
      • Shanghai, China, 200032
        • Zhongshan Hospital Fudan University
      • Shanghai, China, 200120
        • Fudan University Shanghai Cancer Center
      • 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
  • Germany
      • Frankfurt, Germany, 60488
        • Krankenhaus Nordwest
      • Großhansdorf, Germany, 22927
        • LungenClinic Grosshansdorf GmbH
      • Halle, Germany, 06120
        • Krankenhaus Martha-Maria Halle-Doelau gGmbH
      • Löwenstein, Germany, 74245
        • SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein
      • Münster, Germany, 48153
        • Gemeinschaftspraxis für Hämatologie und Onkologie
      • Stuttgart, Germany, 70376
        • Klinik Schillerhöhe
  • Greece
      • Athens, Greece, 185 47
        • Metropolitan Hospital
      • Athens, Greece, 104 31
        • Sotiria Hospital
      • Larissa, Greece, 411 10
        • University Hospital of Larissa
  • Hungary
      • Budapest, Hungary, 1121
        • Orszagos Koranyi Tbc es Pulmonologiai Intezet
      • Mátraháza, Hungary, 3233
        • Matrai Gyogyintezet
      • Szolnok, Hungary, 5004
        • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz
  • 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
      • Rome, Lazio, Italy, 00151
        • Azienda Ospedaliera San Camillo Forlanini
      • Rome, Lazio, Italy, 00168
        • Policlinico Universitario "Agostino Gemelli"
    • Lombardy
      • Milan, Lombardy, Italy, 20141
        • Irccs Istituto Europeo Di Oncologia (IEO)
      • Monza, Lombardy, Italy, 20900
        • Asst Di Monza
      • Rozzano, Lombardy, Italy, 20089
        • Istituto Clinico Humanitas
    • Piedmont
      • Orbassano, Piedmont, Italy, 10043
        • Azienda Sanitaria Ospedaliera S Luigi Gonzaga
    • Umbria
      • Perugia, Umbria, Italy, 06156
        • Azienda Ospedaliera Di Perugia Ospedale S. Maria Della Misericordia
    • Veneto
      • Padua, Veneto, Italy, 35128
        • IOV - Istituto Oncologico Veneto - IRCCS
  • 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, 980-0873
        • 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
      • Sakaishi, Japan, 591-8555
        • NHO 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
  • Mexico
    • Mexico CITY (federal District)
      • CD Mexico, Mexico CITY (federal District), Mexico, 03810
        • Health Pharma Professional Research
      • México, Mexico CITY (federal District), Mexico, 06100
        • Cryptex Investigacion Clinica Sa de Cv
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64710
        • AVIX Investigación Clínica S.C
    • Querétaro
      • Querétaro City, Querétaro, Mexico, 76000
        • Cuidados Oncologicos
  • Netherlands
      • Ede, Netherlands, 6716 RP
        • Ziekenhuis Gelderse Vallei
      • Leeuwarden, Netherlands, 8934 AD
        • Medisch Centrum Leeuwarden
      • The Hague, Netherlands, 2545 AA
        • Hagaziekenhuis, locatie Leyweg
  • Peru
      • Arequipa, Peru, 5154
        • Instituto Regional de Enfermedades Neoplásicas del Sur
      • Lima, Peru, 15038
        • Instituto Nacional de Enfermedades Neoplasicas
      • Lima, Peru, Lima 41
        • Clinica Internacional, Sede San Borja
      • San Isidro, Peru, Lima 27
        • Clinica Ricardo Palma
  • Poland
      • Gda?sk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Olsztyn, Poland, 10-357
        • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
      • Poznan, Poland, 60-569
        • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
  • Russia
    • Moscow Oblast
      • Moscow, Moscow Oblast, Russia, 143422
        • MEDSI Clinical Hospital on Pyatnitsky Highway
      • Moscow, Moscow Oblast, Russia, 105229
        • Main Military Clinical Hospital named after N.N. Burdenko
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 189646
        • Institute of Oncology
      • Saint Petersburg, Sankt-Peterburg, Russia, 197089
        • St. Petersburg Med Univ
      • Saint Petersburg, Sankt-Peterburg, Russia, 197758
        • St. Petersburg Clinical Scientific Center of special services medical assis (oncology)
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Center of Serbia
      • Belgrade, Serbia, 11080
        • University Hospital Medical Center Bezanijska kosa
  • South Korea
      • Cheongju-si, South Korea, 28644
        • Chungbuk National University Hospital
      • Gyeonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital
      • Gyeonggi-do, South Korea, 16499
        • Ajou University Medical Center
      • Incheon, South Korea, 21565
        • Gachon University Gil Medical Center
      • Jeollanam-do, South Korea, 58128
        • Chonnam National University Hwasun Hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 08308
        • Korea University Guro Hospital
      • Seoul, South Korea, 6351
        • Samsung Medical Center
      • Seoul, South Korea, 03181
        • Kangbuk Samsung Medical Center
      • Suwon, South Korea, 442-723
        • St. Vincent's Hospital
  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebrón
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro - Majadahonda
      • Madrid, Spain, 41013
        • Hospital Universitario Virgen del Rocío
      • Málaga, Spain, 29010
        • Hospital Regional Universitario de Málaga
      • Zaragoza, Spain, 50009
        • Hosp Clinico Univ Lozano Blesa
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital Bern
      • Lausanne, Switzerland, 1011
        • CHUV
      • Sankt Gallen, Switzerland, 9000
        • HOCH Health Ostschweiz, Kantonsspital St. Gallen
  • Taiwan
      • Guishan Dist., Taiwan, 33305
        • Chang Gung Memorial Hospital - Linkou Branch
      • Kaohsiung City, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • 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
      • Tainan, Taiwan, 704
        • National Cheng Kung Uni Hospital
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital
      • Zhongzheng Dist., Taiwan, 10048
        • National Taiwan University Hospital
  • Thailand
      • Bangkok, Thailand, 10330
        • Chulalongkorn Hospital
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital
      • Bangkok, Thailand, 10700
        • Faculty of Med. Siriraj Hosp.
      • Songkhla, Thailand, 90110
        • Songklanagarind hospital
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01120
        • Adana Baskent University Hospital
      • Ankara, Turkey (Türkiye), 06100
        • Hacettepe University Medical Faculty
      • Istanbul, Turkey (Türkiye), 34098
        • Istanbul University Cerrahpasa Faculty of Medicine
      • Izmir, Turkey (Türkiye), 35110
        • Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
      • Kadiköy, Turkey (Türkiye), 34722
        • Goztepe Prof.Dr. Suleyman Yalcin City Hospital
      • Malatya, Turkey (Türkiye), 44280
        • Inonu University Medical Faculty of Medicine
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • City Clinical Hospital #4
      • Kryvyi Rih, Ukraine, 50048
        • ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council
      • Uzhhorod, Ukraine, 88000
        • Uzhgorod Nat. University Central Municip Hosp
  • United States
    • Colorado
      • Denver, Colorado, United States, 80220
        • Rocky Mountain Cancer Center - Denver
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale Cancer Center
    • Florida
      • St. Petersburg, Florida, United States, 33705
        • SCRI Florida Cancer Specialists North
      • 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 (Actual)

December 30, 2025

Study Completion (Actual)

December 30, 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)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

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 (Ctis: EU Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

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.

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