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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
Percentage of Participants With Adverse Events (AEs)
Timepoint [1] 0 0
Up to approximately 2 years

Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) 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 epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (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
Open (masking not used)
Who is / are masked / blinded?



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
21/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Sunshine Coast University Hospital; The Adem Crosby Centre - Birtinya
Recruitment hospital [2] 0 0
Monash Health - Clayton
Recruitment postcode(s) [1] 0 0
4575 - Birtinya
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
Argentina
State/province [3] 0 0
Buenos Aires
Country [4] 0 0
Argentina
State/province [4] 0 0
Ciudad Autonoma Buenos Aires
Country [5] 0 0
Argentina
State/province [5] 0 0
Cordoba
Country [6] 0 0
Argentina
State/province [6] 0 0
Rosario
Country [7] 0 0
Brazil
State/province [7] 0 0
BA
Country [8] 0 0
Brazil
State/province [8] 0 0
CE
Country [9] 0 0
Brazil
State/province [9] 0 0
PE
Country [10] 0 0
Brazil
State/province [10] 0 0
RJ
Country [11] 0 0
Brazil
State/province [11] 0 0
RS
Country [12] 0 0
Brazil
State/province [12] 0 0
SP
Country [13] 0 0
China
State/province [13] 0 0
Changzhou
Country [14] 0 0
China
State/province [14] 0 0
Chengdu
Country [15] 0 0
China
State/province [15] 0 0
Guangzhou City
Country [16] 0 0
China
State/province [16] 0 0
Guangzhou
Country [17] 0 0
China
State/province [17] 0 0
Hefei
Country [18] 0 0
China
State/province [18] 0 0
Jinan
Country [19] 0 0
China
State/province [19] 0 0
Kunming
Country [20] 0 0
China
State/province [20] 0 0
Nanchang City
Country [21] 0 0
China
State/province [21] 0 0
Nanjing City
Country [22] 0 0
China
State/province [22] 0 0
Ningbo
Country [23] 0 0
China
State/province [23] 0 0
Qingdao City
Country [24] 0 0
China
State/province [24] 0 0
Shanghai
Country [25] 0 0
China
State/province [25] 0 0
Shengyang
Country [26] 0 0
China
State/province [26] 0 0
Tianjin
Country [27] 0 0
China
State/province [27] 0 0
Wuhan City
Country [28] 0 0
China
State/province [28] 0 0
Xuzhou
Country [29] 0 0
China
State/province [29] 0 0
Zhejiang
Country [30] 0 0
China
State/province [30] 0 0
Zhengzhou
Country [31] 0 0
France
State/province [31] 0 0
Valenciennes
Country [32] 0 0
Italy
State/province [32] 0 0
Lombardia
Country [33] 0 0
Italy
State/province [33] 0 0
Veneto
Country [34] 0 0
Japan
State/province [34] 0 0
Chiba
Country [35] 0 0
Japan
State/province [35] 0 0
Fukuoka
Country [36] 0 0
Japan
State/province [36] 0 0
Hiroshima
Country [37] 0 0
Japan
State/province [37] 0 0
Miyagi
Country [38] 0 0
Japan
State/province [38] 0 0
Oita
Country [39] 0 0
Japan
State/province [39] 0 0
Okayama
Country [40] 0 0
Japan
State/province [40] 0 0
Osaka
Country [41] 0 0
Japan
State/province [41] 0 0
Saitama
Country [42] 0 0
Japan
State/province [42] 0 0
Tokyo
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Busan
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Cheongju-si
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Daegu
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Gyeonggi-do
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Gyeongsangnam-do
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Jeollanam-do
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Seongnam-si
Country [50] 0 0
Korea, Republic of
State/province [50] 0 0
Seoul
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Ulsan
Country [52] 0 0
Peru
State/province [52] 0 0
Lima
Country [53] 0 0
Poland
State/province [53] 0 0
Warszawa
Country [54] 0 0
Slovakia
State/province [54] 0 0
Bratislava
Country [55] 0 0
Slovakia
State/province [55] 0 0
Michalovce
Country [56] 0 0
Slovakia
State/province [56] 0 0
Partizanske
Country [57] 0 0
Spain
State/province [57] 0 0
Cantabria
Country [58] 0 0
Spain
State/province [58] 0 0
Castellon
Country [59] 0 0
Spain
State/province [59] 0 0
Islas Baleares
Country [60] 0 0
Spain
State/province [60] 0 0
LA Coruña
Country [61] 0 0
Spain
State/province [61] 0 0
LAS Palmas
Country [62] 0 0
Spain
State/province [62] 0 0
Granada
Country [63] 0 0
Spain
State/province [63] 0 0
Madrid
Country [64] 0 0
Spain
State/province [64] 0 0
Sevilla
Country [65] 0 0
Taiwan
State/province [65] 0 0
Kaohsiung
Country [66] 0 0
Taiwan
State/province [66] 0 0
Taichung
Country [67] 0 0
Taiwan
State/province [67] 0 0
Taipei
Country [68] 0 0
Taiwan
State/province [68] 0 0
Zhongzheng Dist.
Country [69] 0 0
Thailand
State/province [69] 0 0
Bangkok
Country [70] 0 0
Turkey
State/province [70] 0 0
Ankara
Country [71] 0 0
Turkey
State/province [71] 0 0
Bakirkoy / Istanbul
Country [72] 0 0
Turkey
State/province [72] 0 0
Izmir
Country [73] 0 0
Turkey
State/province [73] 0 0
Seyhan
Country [74] 0 0
Turkey
State/province [74] 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
global-roche-genentech-trials@gene.com
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