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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04513925




Registration number
NCT04513925
Ethics application status
Date submitted
13/08/2020
Date registered
14/08/2020
Date last updated
22/08/2024

Titles & IDs
Public title
A Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Participants With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)
Scientific title
A Phase III, Open-Label, Randomized Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Patients With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent Platinum-Based Chemoradiation
Secondary ID [1] 0 0
2019-004773-29
Secondary ID [2] 0 0
GO41854
Universal Trial Number (UTN)
Trial acronym
SKYSCRAPER-03
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 - Durvalumab

Experimental: Atezolizumab + Tiragolumab - Participants will receive atezolizumab administered intravenously (IV) on Day 1 of each 28-day cycle followed by tiragolumab administered IV on Day 1 of each 28-day cycle for a maximum of 13 cycles.

Active comparator: Durvalumab - Participants will receive durvalumab administered IV during each 28-day cycle for a maximum of 13 cycles.


Treatment: Drugs: Atezolizumab
Atezolizumab 1680 mg every 4 weeks (Q4W) will be administered IV on Day 1 of each 28-day cycle.

Treatment: Drugs: Tiragolumab
Tiragolumab 840 mg Q4W will be administered IV on Day 1 of each 28-day cycle.

Treatment: Drugs: Durvalumab
Durvalumab will be administered based on weight at 10 mg/kg IV every 2 weeks (Q2W) on Days 1 and 15 of each 28-day cycle, or will be administered at a fixed dose of 1500 mg IV every 4 weeks (Q4W) (for participants whose weight \>/= 30 kg) on Day 1 of each 28-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Independent Review Facility (IRF)-assessed Progression Free Survival (PFS) in the PD-L1-positive Analysis Set (PPAS)
Timepoint [1] 0 0
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
Primary outcome [2] 0 0
IRF-assessed PFS in the Full Analysis Set (FAS)
Timepoint [2] 0 0
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
Secondary outcome [1] 0 0
Overall Survival (OS) in the PPAS
Timepoint [1] 0 0
From randomization to death from any cause (up to approximately 114 months)
Secondary outcome [2] 0 0
Investigator-assessed PFS in the PPAS
Timepoint [2] 0 0
Time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first first (up to approximately 114 months)
Secondary outcome [3] 0 0
IRF-assessed Confirmed Objective Response Rate (ORR) in the PPAS
Timepoint [3] 0 0
From randomization up to approximately 114 months
Secondary outcome [4] 0 0
Investigator-assessed Confirmed ORR in the PPAS
Timepoint [4] 0 0
From randomization up to approximately 114 months
Secondary outcome [5] 0 0
IRF-assessed Duration of Response (DOR) in the PPAS
Timepoint [5] 0 0
From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
Secondary outcome [6] 0 0
Investigator-assessed DOR in the PPAS
Timepoint [6] 0 0
From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 114 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 in the PPAS
Timepoint [7] 0 0
Up to approximately 114 months
Secondary outcome [8] 0 0
OS in the FAS
Timepoint [8] 0 0
From randomization to death from any cause (up to approximately 114 months)
Secondary outcome [9] 0 0
Investigator-assessed PFS in the FAS
Timepoint [9] 0 0
Time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first first (up to approximately 114 months)
Secondary outcome [10] 0 0
IRF-assessed Confirmed ORR in the FAS
Timepoint [10] 0 0
From randomization up to approximately 114 months
Secondary outcome [11] 0 0
Investigator-assessed Confirmed ORR in the FAS
Timepoint [11] 0 0
From randomization up to approximately 114 months
Secondary outcome [12] 0 0
IRF-assessed DOR in the FAS
Timepoint [12] 0 0
From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
Secondary outcome [13] 0 0
Investigator-assessed DOR in the FAS
Timepoint [13] 0 0
From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
Secondary outcome [14] 0 0
TTCD Assessed Using EORTC QLQ-C30 Score in the FAS
Timepoint [14] 0 0
Up to approximately 114 months
Secondary outcome [15] 0 0
IRF-assessed PFS Rates at 12 Months, 18 Months and 24 Months in the PPAS
Timepoint [15] 0 0
12, 18 and 24 months
Secondary outcome [16] 0 0
IRF-assessed PFS Rates at 12 Months, 18 Months and 24 Months in the FAS
Timepoint [16] 0 0
12, 18 and 24 months
Secondary outcome [17] 0 0
Investigator-assessed PFS Rates at 12 Months, 18 Months and 24 Months in the PPAS
Timepoint [17] 0 0
12, 18 and 24 months
Secondary outcome [18] 0 0
Investigator-assessed PFS Rates at 12 Months, 18 Months and 24 Months in the FAS
Timepoint [18] 0 0
12, 18 and 24 months
Secondary outcome [19] 0 0
OS Rates at 12 Months, 24 Months, 36 Months and 48 Months in the PPAS
Timepoint [19] 0 0
12, 24, 36 and 48 months
Secondary outcome [20] 0 0
OS Rates at 12 Months, 24 Months, 36 Months and 48 Months in the FAS
Timepoint [20] 0 0
12, 24, 36 and 48 months
Secondary outcome [21] 0 0
Investigator-assessed Time to Death or Distant Metastasis (TTDM) in the PPAS
Timepoint [21] 0 0
From randomization until the first date of distant metastasis or death in the absence of distant metastasis (up to approximately 114 months)
Secondary outcome [22] 0 0
Investigator-assessed TTDM in the FAS
Timepoint [22] 0 0
From randomization until the first date of distant metastasis or death in the absence of distant metastasis (up to approximately 114 months)
Secondary outcome [23] 0 0
Percentage of Participants With Adverse Events
Timepoint [23] 0 0
Up to approximately 114 months

Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Histologically or cytologically documented NSCLC with locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology
* Whole-body Positron Emission Tomography-Computed Tomography (PET-CT) scan, performed prior and within 42 days of the first dose of concurrent chemoradiotherapy (cCRT)
* At least two prior cycles of platinum-based chemotherapy administered concurrently with radiotherapy (RT), which must be completed within 1 to 42 days prior to randomization in the study (one cycle of cCRT is defined as 21 or 28 days)
* The radiotherapy (RT) component in the cCRT must have been at a total dose of radiation of 60 (±10 percent [%]) gray (Gy) (54 Gy to 66 Gy) administered by intensity modulated RT (preferred) or 3D-conforming technique
* No progression during or following concurrent platinum-based CRT
* A known PD-L1 result
* Life expectancy >/= 12 weeks
* Adequate hematologic and end-organ function
* Female participants must be willing to avoid pregnancy for 90 days after the final dose of tiragolumab and 5 months after the final dose of atezolizumab, or for 3 months after the final dose of durvalumab
* Male participants must remain abstinent or use a condom during the treatment period and for 90 days after the final dose of tiragolumab
* Male participants must not donate sperm during the treatment period and for 90 days after the final dose of tiragolumab
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 and/or any history of prior treatment for NSCLC (participants must be newly diagnosed with unresectable Stage III disease)
* NSCLC known to have a mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene
* Any evidence of Stage IV disease
* Treatment with sequential CRT for locally advanced NSCLC
* Participants with locally advanced NSCLC who have progressed during or after the definitive cCRT prior to randomization
* Any Grade >2 unresolved toxicity from previous CRT
* Grade >= 2 pneumonitis from prior CRT
* 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
* History of malignancy other than NSCLC within 5 years prior to screening with the exception of malignancies with a negligible risk of metastasis or death
* Prior allogeneic stem cell or solid organ transplantation
* Active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening
* Treatment with investigational therapy within 28 days prior to initiation of study treatment
* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4, anti-T-cell immunoreceptor with Ig and ITIM domains (anti-TIGIT), anti-PD-1 and anti-PD-L1
* Any prior Grade >/= 3 immune-mediated adverse event or any unresolved Grade > 1 immune-mediated adverse event while receiving any previous immunotherapy agent other than immune checkpoint blockade agents
* Treatment with systemic immunosuppressive medication
* Women who are pregnant, or breastfeeding

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
24/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2027
Actual
Sample size
Target
Accrual to date
Final
829
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 0 0
Macarthur Cancer Therapy Centre - Campbelltown
Recruitment hospital [3] 0 0
St George Hospital; Cancer Care Centre - Kogarah
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [6] 0 0
Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit - Bull Creek
Recruitment hospital [7] 0 0
Monash Health Translational Precinct; Clinical Trials Centre, Level 3 - Victoria
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2560 - Campbelltown
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
6149 - Bull Creek
Recruitment postcode(s) [7] 0 0
3168 - Victoria
Recruitment outside Australia
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United States of America
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Arkansas
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Missouri
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Nevada
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South Carolina
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Tennessee
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Virginia
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Argentina
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Ciudad Autonoma Buenos Aires
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Cordoba
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Rosario
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Innsbruck
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Charleroi
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BA
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Ontario
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Caen
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Vantoux
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Villejuif cedex
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Germany
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Braunschweig
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Göttingen
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Heidelberg
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Köln
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München
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Regensburg
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Greece
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Asvestochori
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Greece
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Athens
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Heraklion
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Greece
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Kifisia
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Lazio
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Italy
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Liguria
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Lombardia
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Toscana
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Aichi
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Hyogo
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Niigata
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Shizuoka
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Tokyo
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Wakayama
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Daegu
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Gyeonggi-do
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Gyeongsangnam-do
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Korea, Republic of
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Incheon
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Seongnam-si
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Seoul
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Netherlands
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Amersfoort
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Breda
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Leidschendam
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Sittard-Geleen
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Auckland
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Poland
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Gdansk
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Barcelona
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Castellon
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Islas Baleares
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LA Coruña
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Malaga
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Sevilla
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Taichung
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Taipei
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Thailand
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Bangkok
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Thailand
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Songkhla
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Bornova, ?zm?r
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Turkey
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Diyarbakir
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Turkey
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Edirne
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Turkey
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Istanbul
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Turkey
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Malatya
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United Kingdom
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Birmingham
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United Kingdom
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Cambridge
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United Kingdom
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Glasgow
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United Kingdom
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Huddersfield
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United Kingdom
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Leicester
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United Kingdom
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Maidstone
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United Kingdom
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Manchester
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United Kingdom
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Sheffield

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 atezolizumab in combination with tiragolumab compared with durvalumab in participants with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) who have received at least two cycles of concurrent platinum-based chemoradiotherapy (CRT) and have not had radiographic disease progression.
Trial website
https://clinicaltrials.gov/study/NCT04513925
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
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/study/NCT04513925