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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06267001




Registration number
NCT06267001
Ethics application status
Date submitted
12/02/2024
Date registered
20/02/2024

Titles & IDs
Public title
A Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy
Scientific title
A Phase III, Randomized, Double-blind Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Stage IIB, IIIA, or Select IIIB, PD-L1 Positive, Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy
Secondary ID [1] 0 0
2023-506696-10-00
Secondary ID [2] 0 0
GO45006
Universal Trial Number (UTN)
Trial acronym
SKYSCRAPER-15
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer (NSCLC) 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 - Placebo

Experimental: Atezolizumab + Tiragolumab - Participants will receive atezolizumab and tiragolumab intravenously (IV).

Placebo comparator: Atezolizumab + Placebo - Participants will receive atezolizumab and placebo IV.


Treatment: Drugs: Atezolizumab
Atezolizumab will be administered IV.

Treatment: Drugs: Tiragolumab
Tiragolumab will be administered IV.

Treatment: Drugs: Placebo
Placebo will be administered IV.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-free Survival (DFS)
Timepoint [1] 0 0
Up to approximately 10 years
Secondary outcome [1] 0 0
Percentage of Participants With Adverse Events (AEs)
Timepoint [1] 0 0
Up to approximately 15 years
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to approximately 15 years
Secondary outcome [3] 0 0
DFS Rate
Timepoint [3] 0 0
Year 3, Year 5, Year 7
Secondary outcome [4] 0 0
Percentage of Participants Who Maintained or Meaningfully Improved from Baseline in Patient-reported Role, Emotional, and Physical Functioning and Global Health Status (GHS)/Quality of Life (QoL)
Timepoint [4] 0 0
Up to approximately 1 year
Secondary outcome [5] 0 0
Serum Concentration of Tiragolumab
Timepoint [5] 0 0
Up to approximately 1 year
Secondary outcome [6] 0 0
Serum Concentration of Atezolizumab
Timepoint [6] 0 0
Up to approximately 1 year
Secondary outcome [7] 0 0
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab
Timepoint [7] 0 0
Up to approximately 1 year
Secondary outcome [8] 0 0
Percentage of Participants With ADAs to Atezolizumab
Timepoint [8] 0 0
Up to approximately 1 year

Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Histological or cytological diagnosis of Stage IIB, IIIA, and select IIIB NSCLC of either non-squamous or squamous histology
* Participants must have had complete resection of NSCLC
* Participants must have received between one to four cycles of adjuvant histology-based platinum doublet chemotherapy
* Participants must have recovered adequately from surgery and from adjuvant chemotherapy
* Tumor cell PD-L1 expression at >/= 1%
* Adequate hematologic and end-organ function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any history of prior NSCLC within the last 5 years
* Any evidence of residual disease or disease recurrence following surgical resection of NSCLC, or during or following adjuvant chemotherapy
* NSCLC known to have mutation in the EGFR gene or an ALK fusion oncogene

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 assessing the outcomes
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2039
Actual
Sample size
Target
1150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Sunshine Coast University Hospital; The Adem Crosby Centre - Birtinya
Recruitment hospital [2] 0 0
Greenslopes Private Hospital; Gallipoli Research Centre - Greenslopes
Recruitment hospital [3] 0 0
Cancer Research SA - Adelaide
Recruitment hospital [4] 0 0
Monash Health - Clayton
Recruitment postcode(s) [1] 0 0
4575 - Birtinya
Recruitment postcode(s) [2] 0 0
4120 - Greenslopes
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
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United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
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Maryland
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United States of America
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Michigan
Country [9] 0 0
United States of America
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Montana
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United States of America
State/province [10] 0 0
New Mexico
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
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United States of America
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Oregon
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United States of America
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Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Argentina
State/province [17] 0 0
Buenos Aires
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Ciudad Autonoma de Buenos Aires
Country [20] 0 0
Argentina
State/province [20] 0 0
Cordoba
Country [21] 0 0
Argentina
State/province [21] 0 0
Rosario
Country [22] 0 0
Belgium
State/province [22] 0 0
Auderghem
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Belgium
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Gent
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Belgium
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Haine-Saint-Paul
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Belgium
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Hasselt
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Belgium
State/province [26] 0 0
Kortrijk
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Brazil
State/province [27] 0 0
BA
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Brazil
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CE
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Brazil
State/province [29] 0 0
PE
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Brazil
State/province [30] 0 0
RJ
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Brazil
State/province [31] 0 0
RS
Country [32] 0 0
Brazil
State/province [32] 0 0
SP
Country [33] 0 0
China
State/province [33] 0 0
Changzhou
Country [34] 0 0
China
State/province [34] 0 0
Chengdu
Country [35] 0 0
China
State/province [35] 0 0
Guangzhou City
Country [36] 0 0
China
State/province [36] 0 0
Guangzhou
Country [37] 0 0
China
State/province [37] 0 0
Hefei
Country [38] 0 0
China
State/province [38] 0 0
Jinan
Country [39] 0 0
China
State/province [39] 0 0
Kunming
Country [40] 0 0
China
State/province [40] 0 0
Nanchang City
Country [41] 0 0
China
State/province [41] 0 0
Nanjing City
Country [42] 0 0
China
State/province [42] 0 0
Ningbo
Country [43] 0 0
China
State/province [43] 0 0
Qingdao City
Country [44] 0 0
China
State/province [44] 0 0
Shanghai
Country [45] 0 0
China
State/province [45] 0 0
Shengyang
Country [46] 0 0
China
State/province [46] 0 0
Tianjin
Country [47] 0 0
China
State/province [47] 0 0
Wuhan City
Country [48] 0 0
China
State/province [48] 0 0
Xuzhou
Country [49] 0 0
China
State/province [49] 0 0
Zhejiang
Country [50] 0 0
China
State/province [50] 0 0
Zhengzhou
Country [51] 0 0
France
State/province [51] 0 0
Valenciennes
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Greece
State/province [52] 0 0
Athens
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Hong Kong
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Hong Kong
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Italy
State/province [54] 0 0
Friuli-Venezia Giulia
Country [55] 0 0
Italy
State/province [55] 0 0
Lombardia
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Italy
State/province [56] 0 0
Piemonte
Country [57] 0 0
Italy
State/province [57] 0 0
Toscana
Country [58] 0 0
Italy
State/province [58] 0 0
Veneto
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Japan
State/province [59] 0 0
Chiba
Country [60] 0 0
Japan
State/province [60] 0 0
Fukuoka
Country [61] 0 0
Japan
State/province [61] 0 0
Hiroshima
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Japan
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Miyagi
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Japan
State/province [63] 0 0
Oita
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Japan
State/province [64] 0 0
Okayama
Country [65] 0 0
Japan
State/province [65] 0 0
Osaka
Country [66] 0 0
Japan
State/province [66] 0 0
Saitama
Country [67] 0 0
Japan
State/province [67] 0 0
Tokyo
Country [68] 0 0
Korea, Republic of
State/province [68] 0 0
Busan
Country [69] 0 0
Korea, Republic of
State/province [69] 0 0
Cheongju-si
Country [70] 0 0
Korea, Republic of
State/province [70] 0 0
Daegu
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Korea, Republic of
State/province [71] 0 0
Gyeonggi-do
Country [72] 0 0
Korea, Republic of
State/province [72] 0 0
Gyeongsangnam-do
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Jeollanam-do
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Korea, Republic of
State/province [74] 0 0
Seongnam-si
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Korea, Republic of
State/province [75] 0 0
Seoul
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Korea, Republic of
State/province [76] 0 0
Ulsan
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Mexico
State/province [77] 0 0
Mexico CITY (federal District)
Country [78] 0 0
Mexico
State/province [78] 0 0
Nuevo LEON
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Mexico
State/province [79] 0 0
Ciudad de México
Country [80] 0 0
Peru
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Lima
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Peru
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Trujillo
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Poland
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Gdansk
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Poland
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Krakow
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Poland
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Olsztyn
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Poland
State/province [85] 0 0
Poznan
Country [86] 0 0
Poland
State/province [86] 0 0
Warszawa
Country [87] 0 0
Romania
State/province [87] 0 0
Brasov
Country [88] 0 0
Romania
State/province [88] 0 0
Bucharest
Country [89] 0 0
Romania
State/province [89] 0 0
Cluj Napoca
Country [90] 0 0
Romania
State/province [90] 0 0
Floresti
Country [91] 0 0
Romania
State/province [91] 0 0
Timi?oara
Country [92] 0 0
Romania
State/province [92] 0 0
Timisoara
Country [93] 0 0
Slovakia
State/province [93] 0 0
Bratislava
Country [94] 0 0
Slovakia
State/province [94] 0 0
Michalovce
Country [95] 0 0
Slovakia
State/province [95] 0 0
Partizanske
Country [96] 0 0
Spain
State/province [96] 0 0
Cantabria
Country [97] 0 0
Spain
State/province [97] 0 0
Castellon
Country [98] 0 0
Spain
State/province [98] 0 0
Islas Baleares
Country [99] 0 0
Spain
State/province [99] 0 0
LA Coruña
Country [100] 0 0
Spain
State/province [100] 0 0
LAS Palmas
Country [101] 0 0
Spain
State/province [101] 0 0
Granada
Country [102] 0 0
Spain
State/province [102] 0 0
Madrid
Country [103] 0 0
Spain
State/province [103] 0 0
Sevilla
Country [104] 0 0
Taiwan
State/province [104] 0 0
Kaohsiung
Country [105] 0 0
Taiwan
State/province [105] 0 0
Taichung
Country [106] 0 0
Taiwan
State/province [106] 0 0
Taipei
Country [107] 0 0
Taiwan
State/province [107] 0 0
Zhongzheng Dist.
Country [108] 0 0
Thailand
State/province [108] 0 0
Bangkok
Country [109] 0 0
Thailand
State/province [109] 0 0
Chang Mai
Country [110] 0 0
Turkey
State/province [110] 0 0
Ankara
Country [111] 0 0
Turkey
State/province [111] 0 0
Bakirkoy / Istanbul
Country [112] 0 0
Turkey
State/province [112] 0 0
Izmir
Country [113] 0 0
Turkey
State/province [113] 0 0
Seyhan
Country [114] 0 0
Turkey
State/province [114] 0 0
Çankaya/Ankara

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
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
Reference Study ID Number: GO45006 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
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).
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06267001