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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04294810




Registration number
NCT04294810
Ethics application status
Date submitted
2/03/2020
Date registered
4/03/2020
Date last updated
12/04/2024

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 0 0
2019-002925-31
Secondary ID [2] 0 0
GO41717
Universal Trial Number (UTN)
Trial acronym
SKYSCRAPER-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Tiragolumab
Treatment: Drugs - Matching Placebo

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.

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.


Treatment: Drugs: Atezolizumab
Atezolizumab 1200 milligrams (mg) administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.

Treatment: Drugs: Tiragolumab
Tiragolumab 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.

Treatment: Drugs: Matching Placebo
Matching Placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Investigator-Assessed Progression-Free Survival (PFS) in the Primary Analysis Set
Timepoint [1] 0 0
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
Primary outcome [2] 0 0
Overall Survival (OS) in the Primary Analysis Set
Timepoint [2] 0 0
From randomization to death from any cause (up to approximately 59 months)
Primary outcome [3] 0 0
Percentage of Participants With Adverse Events (AEs)
Timepoint [3] 0 0
Up to approximately 59 months
Primary outcome [4] 0 0
Percentage of Participants With Cytokine-Release Syndrome (CRS)
Timepoint [4] 0 0
Up to approximately 59 months
Secondary outcome [1] 0 0
Investigator-Assessed PFS in the Secondary Analysis Set
Timepoint [1] 0 0
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
Secondary outcome [2] 0 0
OS in the Secondary Analysis Set
Timepoint [2] 0 0
From randomization to death from any cause (up to approximately 59 months)
Secondary outcome [3] 0 0
Investigator-Assessed Confirmed Objective Response Rate (ORR)
Timepoint [3] 0 0
From randomization up to approximately 59 months
Secondary outcome [4] 0 0
Investigator-Assessed Duration of Response (DOR)
Timepoint [4] 0 0
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)
Secondary outcome [5] 0 0
Investigator-Assessed PFS Rates at 6 Months and 12 Months
Timepoint [5] 0 0
6 months, 12 months
Secondary outcome [6] 0 0
OS Rates at 12 Months and 24 Months
Timepoint [6] 0 0
12 months, 24 months
Secondary outcome [7] 0 0
Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score
Timepoint [7] 0 0
From randomization until the first confirmed clinically meaningful deterioration (up to approximately 59 months)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/03/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/02/2025
Actual
Sample size
Target
Accrual to date
Final
620
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 0 0
Austin Hospital Olivia Newton John Cancer Centre - Heidelberg
Recruitment hospital [3] 0 0
Peter Maccallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
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United States of America
State/province [2] 0 0
Connecticut
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United States of America
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Florida
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United States of America
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Minnesota
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United States of America
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Tennessee
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United States of America
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Virginia
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United States of America
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Washington
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Austria
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Linz
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Austria
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Wien
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Brazil
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RS
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Brazil
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SP
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China
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Beijing
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China
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Changchun City
Country [14] 0 0
China
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Changzhou
Country [15] 0 0
China
State/province [15] 0 0
Chengdu City
Country [16] 0 0
China
State/province [16] 0 0
Chengdu
Country [17] 0 0
China
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Chongqing
Country [18] 0 0
China
State/province [18] 0 0
Fuzhou
Country [19] 0 0
China
State/province [19] 0 0
Guangzhou
Country [20] 0 0
China
State/province [20] 0 0
Haikou
Country [21] 0 0
China
State/province [21] 0 0
Hangzhou City
Country [22] 0 0
China
State/province [22] 0 0
Harbin
Country [23] 0 0
China
State/province [23] 0 0
Jinan City
Country [24] 0 0
China
State/province [24] 0 0
Meizhou City
Country [25] 0 0
China
State/province [25] 0 0
Nanchang
Country [26] 0 0
China
State/province [26] 0 0
Nantong City
Country [27] 0 0
China
State/province [27] 0 0
Shanghai City
Country [28] 0 0
China
State/province [28] 0 0
Shanghai
Country [29] 0 0
China
State/province [29] 0 0
Tianjin
Country [30] 0 0
China
State/province [30] 0 0
Wuhan City
Country [31] 0 0
China
State/province [31] 0 0
Xi'an
Country [32] 0 0
China
State/province [32] 0 0
Xiamen
Country [33] 0 0
China
State/province [33] 0 0
Zhejiang
Country [34] 0 0
Denmark
State/province [34] 0 0
Aalborg
Country [35] 0 0
Denmark
State/province [35] 0 0
København Ø
Country [36] 0 0
Denmark
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Roskilde
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Germany
State/province [37] 0 0
Frankfurt
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Germany
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Großhansdorf
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Germany
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Halle (Saale)
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Germany
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Immenhausen
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Germany
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Löwenstein
Country [42] 0 0
Germany
State/province [42] 0 0
Münster
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Germany
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Stuttgart
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Greece
State/province [44] 0 0
Athens
Country [45] 0 0
Greece
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Larissa
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Greece
State/province [46] 0 0
Thessaloniki
Country [47] 0 0
Hungary
State/province [47] 0 0
Budapest
Country [48] 0 0
Hungary
State/province [48] 0 0
Matrahaza
Country [49] 0 0
Hungary
State/province [49] 0 0
Szolnok
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Italy
State/province [50] 0 0
Campania
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Italy
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Lazio
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Italy
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Lombardia
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Italy
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Piemonte
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Italy
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Umbria
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Italy
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Veneto
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Miyagi
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Japan
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Niigata
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Sakai-shi
Country [64] 0 0
Japan
State/province [64] 0 0
Shizuoka
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Japan
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Tokyo
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Korea, Republic of
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Cheongju si
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Incheon
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Korea, Republic of
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Jeollanam-do
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon
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Mexico
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Mexico CITY (federal District)
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Mexico
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Nuevo LEON
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Mexico
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Queretaro
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Netherlands
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'S Hertogenbosch
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Netherlands
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Den-Haag
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Netherlands
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EDE
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Netherlands
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Leeuwarden
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Peru
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Arequipa
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Peru
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Lima
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Peru
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San Isidro
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Poland
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Gdansk
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Poland
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Olsztyn
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Poland
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Otwock
Country [86] 0 0
Poland
State/province [86] 0 0
Poznan
Country [87] 0 0
Russian Federation
State/province [87] 0 0
Moskovskaja Oblast
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Sankt Petersburg
Country [89] 0 0
Russian Federation
State/province [89] 0 0
Novosibirsk
Country [90] 0 0
Russian Federation
State/province [90] 0 0
Yaroslavl
Country [91] 0 0
Serbia
State/province [91] 0 0
Belgrade
Country [92] 0 0
Serbia
State/province [92] 0 0
Sremska Kamenica
Country [93] 0 0
Spain
State/province [93] 0 0
Barcelona
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Spain
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Madrid
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Spain
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Alicante
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Spain
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Malaga
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Spain
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Sevilla
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Spain
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Zaragoza
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Switzerland
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Bern
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Switzerland
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Lausanne
Country [101] 0 0
Switzerland
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St. Gallen
Country [102] 0 0
Taiwan
State/province [102] 0 0
Kaohsiung City
Country [103] 0 0
Taiwan
State/province [103] 0 0
Kaohsiung
Country [104] 0 0
Taiwan
State/province [104] 0 0
New Taipei City
Country [105] 0 0
Taiwan
State/province [105] 0 0
Taichung
Country [106] 0 0
Taiwan
State/province [106] 0 0
Tainan
Country [107] 0 0
Taiwan
State/province [107] 0 0
Taipei
Country [108] 0 0
Taiwan
State/province [108] 0 0
Zhongzheng Dist.
Country [109] 0 0
Thailand
State/province [109] 0 0
Bangkok
Country [110] 0 0
Thailand
State/province [110] 0 0
Songkhla
Country [111] 0 0
Turkey
State/province [111] 0 0
Adana
Country [112] 0 0
Turkey
State/province [112] 0 0
Ankara
Country [113] 0 0
Turkey
State/province [113] 0 0
Istanbul
Country [114] 0 0
Turkey
State/province [114] 0 0
Izmir
Country [115] 0 0
Turkey
State/province [115] 0 0
Kadiköy
Country [116] 0 0
Turkey
State/province [116] 0 0
Malatya
Country [117] 0 0
Turkey
State/province [117] 0 0
Seyhan
Country [118] 0 0
Ukraine
State/province [118] 0 0
Dnipropetrovsk
Country [119] 0 0
Ukraine
State/province [119] 0 0
Ivano-Frankivsk
Country [120] 0 0
Ukraine
State/province [120] 0 0
Kryvyi Rih
Country [121] 0 0
Ukraine
State/province [121] 0 0
Uzhgorod

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04294810
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04294810