Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
21/06/2024

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
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Montana
Country [7] 0 0
United States of America
State/province [7] 0 0
New Mexico
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
Ciudad Autonoma Buenos Aires
Country [14] 0 0
Argentina
State/province [14] 0 0
Ciudad Autonoma de Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Cordoba
Country [16] 0 0
Argentina
State/province [16] 0 0
Rosario
Country [17] 0 0
Brazil
State/province [17] 0 0
BA
Country [18] 0 0
Brazil
State/province [18] 0 0
CE
Country [19] 0 0
Brazil
State/province [19] 0 0
PE
Country [20] 0 0
Brazil
State/province [20] 0 0
RS
Country [21] 0 0
Brazil
State/province [21] 0 0
SP
Country [22] 0 0
China
State/province [22] 0 0
Changzhou
Country [23] 0 0
China
State/province [23] 0 0
Chengdu
Country [24] 0 0
China
State/province [24] 0 0
Guangzhou City
Country [25] 0 0
China
State/province [25] 0 0
Guangzhou
Country [26] 0 0
China
State/province [26] 0 0
Jinan
Country [27] 0 0
China
State/province [27] 0 0
Kunming
Country [28] 0 0
China
State/province [28] 0 0
Nanchang City
Country [29] 0 0
China
State/province [29] 0 0
Nanjing City
Country [30] 0 0
China
State/province [30] 0 0
Ningbo
Country [31] 0 0
China
State/province [31] 0 0
Qingdao City
Country [32] 0 0
China
State/province [32] 0 0
Shanghai
Country [33] 0 0
China
State/province [33] 0 0
Shengyang
Country [34] 0 0
China
State/province [34] 0 0
Tianjin
Country [35] 0 0
China
State/province [35] 0 0
Wuhan City
Country [36] 0 0
China
State/province [36] 0 0
Xuzhou
Country [37] 0 0
China
State/province [37] 0 0
Zhejiang
Country [38] 0 0
China
State/province [38] 0 0
Zhengzhou
Country [39] 0 0
Hong Kong
State/province [39] 0 0
Hong Kong
Country [40] 0 0
Japan
State/province [40] 0 0
Chiba
Country [41] 0 0
Japan
State/province [41] 0 0
Fukuoka
Country [42] 0 0
Japan
State/province [42] 0 0
Hiroshima
Country [43] 0 0
Japan
State/province [43] 0 0
Miyagi
Country [44] 0 0
Japan
State/province [44] 0 0
Oita
Country [45] 0 0
Japan
State/province [45] 0 0
Okayama
Country [46] 0 0
Japan
State/province [46] 0 0
Osaka
Country [47] 0 0
Japan
State/province [47] 0 0
Saitama
Country [48] 0 0
Japan
State/province [48] 0 0
Tokyo
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Busan
Country [50] 0 0
Korea, Republic of
State/province [50] 0 0
Cheongju si
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Daegu
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Gyeonggi-do
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Gyeongsangnam-do
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Jeollanam-do
Country [55] 0 0
Korea, Republic of
State/province [55] 0 0
Seongnam-si
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Seoul
Country [57] 0 0
Korea, Republic of
State/province [57] 0 0
Ulsan
Country [58] 0 0
Slovakia
State/province [58] 0 0
Bratislava
Country [59] 0 0
Taiwan
State/province [59] 0 0
Kaohsiung
Country [60] 0 0
Taiwan
State/province [60] 0 0
Taichung
Country [61] 0 0
Taiwan
State/province [61] 0 0
Taipei
Country [62] 0 0
Thailand
State/province [62] 0 0
Bangkok
Country [63] 0 0
Thailand
State/province [63] 0 0
Chang Mai

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 this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab administered to participants with non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy.
Trial website
https://clinicaltrials.gov/study/NCT06267001
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06267001