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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04513925
Ethics application status
Date submitted
13/08/2020
Date registered
14/08/2020
Date last updated
29/03/2021

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) 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)
Timepoint [1] 0 0
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 90 months)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From randomization to death from any cause (up to approximately 90 months)
Secondary outcome [2] 0 0
Investigator-assessed PFS
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 90 months)
Secondary outcome [3] 0 0
Confirmed Objective Response Rate (ORR)
Timepoint [3] 0 0
From randomization up to approximately 90 months
Secondary outcome [4] 0 0
Duration of Response (DOR)
Timepoint [4] 0 0
From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 90 months)
Secondary outcome [5] 0 0
PFS Rates at 12 Months, 18 Months and 24 Months
Timepoint [5] 0 0
12, 18 and 24 months
Secondary outcome [6] 0 0
OS Rates at 12 Months, 24 Months, 36 Months and 48 Months
Timepoint [6] 0 0
12, 24, 36 and 48 months
Secondary outcome [7] 0 0
Time to Death or Distant Metastasis (TTDM)
Timepoint [7] 0 0
From randomization until the first date of distant metastasis or death in the absence of distant metastasis (up to approximately 90 months)
Secondary outcome [8] 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 - TTCD using EORTC QLQ-C30 is an initial 10-point decrease in global health status (GHS) and physical functioning from baseline that must be held for all subsequent assessment timepoints or followed by death attributable to cancer progression. EORTC QLQ-C30: a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting and pain), GHS and quality of life (QoL), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) with a recall period of the previous week. Functioning items are scored on a 4-point scale: 1=Not at all to 4=Very much, with higher score indicating worse outcome. Symptom items (GHS and QoL) are scored on a 7-point scale: 1=Very poor to 7=Excellent. Scores will be linearly transformed with a minimum score of 0 and maximum score of 100. Higher score indicates better outcome.
Timepoint [8] 0 0
Up to approximatley 90 months
Secondary outcome [9] 0 0
Percentage of Participants With Adverse Events
Timepoint [9] 0 0
Up to 90 approximately months
Secondary outcome [10] 0 0
Serum Concentration of Tiragolumab
Timepoint [10] 0 0
Pre-dose and post-dose on Day 1 of Cycles 1 and 3 (cycle=28 days) and predose on Day 1 of Cycles 2, 4, 8, 10 and 12 and at treatment discontinuation (TD) visit (up to approximately 90 months)
Secondary outcome [11] 0 0
Serum Concentration of Atezolizumab
Timepoint [11] 0 0
Pre-dose and post-dose on Day 1 of Cycle 1 (cycle=28 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 10 and 12 and at TD visit (up to approximately 90 months)
Secondary outcome [12] 0 0
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab
Timepoint [12] 0 0
Predose on Day 1 of Cycles 2, 3, 4, 8, 10 and 12 (cycle=28 days) and at TD visit (up to approximately 90 months)
Secondary outcome [13] 0 0
Percentage of Participants With ADAs to Atezolizumab
Timepoint [13] 0 0
Predose on Day 1 of Cycles 2, 3, 4, 8, 10 and 12 (cycle=28 days) and at TD visit (up to approximately 90 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 (CRT)

- At least two prior cycles of platinum-based chemotherapy concurrent with radiotherapy
(cCRT), 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

- Tumor PD-L1 expression

- 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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any history of prior NSCLC

- 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 concurrent CRT 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

- 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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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Arizona
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California
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Delaware
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Daegu
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Incheon
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Seoul
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Zwolle
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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, I?zmi?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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London
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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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Nottingham
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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/show/NCT04513925
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Clinical Trials
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Hoffmann-La Roche
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Contact person for public queries
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GO41854 www.roche.com/about_roche/roche_worldwide.html
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888-662-6728 (U.S. Only)
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global-roche-genentech-trials@gene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04513925