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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04294810




Registration number
NCT04294810
Ethics application status
Date submitted
2/03/2020
Date registered
4/03/2020
Date last updated
25/11/2020

Titles & IDs
Public title
A Study of Tiragolumab in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer
Scientific title
A Phase III, Randomized, Double-Blinded, Placebo-Controlled Study of Tiragolumab, an Anti-Tigit Antibody, in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
2019-002925-31
Secondary ID [2] 0 0
GO41717
Universal Trial Number (UTN)
Trial acronym
SKYSCRAPER-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 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 - Matching Placebo

Experimental: Tiragolumab + Atezolizumab - Participants will receive atezolizumab followed by tiragolumab every 3 weeks (Q3W) on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity.

Placebo Comparator: Placebo + Atezolizumab - Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity.


Treatment: Drugs: Atezolizumab
Atezolizumab 1200 milligrams (mg) administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.

Treatment: Drugs: Tiragolumab
Tiragolumab 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.

Treatment: Drugs: Matching Placebo
Matching Placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Investigator-Assessed Progression-Free Survival (PFS) in the Primary Population
Timepoint [1] 0 0
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
Primary outcome [2] 0 0
Overall Survival (OS) in the Primary Population
Timepoint [2] 0 0
From randomization to death from any cause (up to approximately 59 months)
Secondary outcome [1] 0 0
Investigator-Assessed PFS in the Secondary Population
Timepoint [1] 0 0
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
Secondary outcome [2] 0 0
OS in the Secondary Population
Timepoint [2] 0 0
From randomization to death from any cause (up to approximately 59 months)
Secondary outcome [3] 0 0
Investigator-Assessed PFS in Participants With High Tumor Programmed Death-Ligand 1 (PD-L1) Expression
Timepoint [3] 0 0
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
Secondary outcome [4] 0 0
OS in Participants With High Tumor PD-L1 Expression
Timepoint [4] 0 0
From randomization to death from any cause (up to approximately 59 months)
Secondary outcome [5] 0 0
Investigator-Assessed Confirmed Objective Response Rate (ORR)
Timepoint [5] 0 0
From randomization up to approximately 59 months
Secondary outcome [6] 0 0
Investigator-Assessed Duration of Response (DOR)
Timepoint [6] 0 0
From the first occurrence of a documented confirmed objective response to disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
Secondary outcome [7] 0 0
Investigator-Assessed PFS Rates at 6 Months and 12 Months
Timepoint [7] 0 0
6 months, 12 months
Secondary outcome [8] 0 0
OS Rates at 12 Months and 24 Months
Timepoint [8] 0 0
12 months, 24 months
Secondary outcome [9] 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)/quality of life (QoL) and functioning from baseline that must be held for at least two consecutive assessments or an initial clinically meaningful decrease above baseline followed by death. 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 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 [9] 0 0
From randomization until the first confirmed clinically meaningful deterioration (up to approximately 59 months)
Secondary outcome [10] 0 0
Percentage of Participants With Adverse Events (AEs)
Timepoint [10] 0 0
Up to approximately 59 months
Secondary outcome [11] 0 0
Minimum Serum Concentration (Cmin) of Tiragolumab
Timepoint [11] 0 0
Predose and postdose on Day 1 of Cycle 1 (cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at treatment discontinuation (TD) visit (up to approximately 59 months)
Secondary outcome [12] 0 0
Maximum Serum Concentration (Cmax) of Tiragolumab
Timepoint [12] 0 0
Predose and postdose on Day 1 of Cycle 1 (cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to approximately 59 months)
Secondary outcome [13] 0 0
Cmin of Atezolizumab
Timepoint [13] 0 0
Predose and postdose on Day 1 of Cycle 1 (cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to approximately 59 months)
Secondary outcome [14] 0 0
Cmax of Atezolizumab
Timepoint [14] 0 0
Predose and postdose on Day 1 of Cycle 1 (cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to approximately 59 months)
Secondary outcome [15] 0 0
Percentage of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab
Timepoint [15] 0 0
Predose on Day 1 of Cycles (cycle=21 days) 1, 2, 3, 4, 8,12 and 16 and at TD visit (up to approximately 59 months)
Secondary outcome [16] 0 0
Percentage of Participants With ADAs to Atezolizumab
Timepoint [16] 0 0
Predose on Day 1 of Cycles (cycle=21 days) 1, 2, 3, 4, 8,12 and 16 and at TD visit (up to approximately 59 months)

Eligibility
Key inclusion criteria
- Histologically or cytologically documented locally advanced or recurrent NSCLC not
eligible for curative surgery and/or definitive radiotherapy with or without
chemoradiotherapy, or metastatic Stage IV non-squamous or squamous NSCLC

- No prior systemic treatment for metastatic NSCLC

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- High tumor tissue PD-L1 expression

- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1
(RECIST v1.1)

- Adequate hematologic and end-organ function
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known mutation in the EGFR gene or an ALK fusion oncogene

- Symptomatic, untreated, or actively progressing central nervous system metastases

- 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

- Malignancies other than NSCLC within 5 years, with the exception of those with a
negligible risk of metastasis or death treated with expected curative outcome

- Severe infection within 4 weeks prior to initiation of study treatment

- Positive test result for human immunodeficiency virus (HIV)

- Active hepatitis B or hepatitis C

- Treatment with investigational therapy within 28 days prior to initiation of study
treatment

- Prior treatment with CD137 agonists or immune checkpoint blockade therapies,
anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies

- Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug elimination
half-lives prior to initiation of study treatment

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 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
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,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 0 0
Frankston Hospital; Oncology/Haematology - Frankston
Recruitment hospital [4] 0 0
Austin Hospital Olivia Newton John Cancer Centre - Heidelberg
Recruitment hospital [5] 0 0
Peter Maccallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment outside Australia
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United States of America
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Colorado
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Connecticut
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Capital Federal
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Argentina
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Vicente López
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Argentina
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Viedma, Rio Negro
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Linz
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Beijing
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Shenyang
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Wuhan City
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Xi'an
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Zhejiang
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Aalborg
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Großhansdorf
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Halle (Saale)
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Gyeonggi-do
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Incheon
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Jeollanam-do
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Seongnam-si
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Seoul
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Suwon
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'S Hertogenbosch
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EDE
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Lima
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Russian Federation
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Moskovskaja Oblast
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Russian Federation
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Moscow
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Russian Federation
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ST Petersburg
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Yaroslavl
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Serbia
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Belgrade
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Serbia
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Sremska Kamenica
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Barcelona
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Sevilla
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Switzerland
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Lausanne
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Switzerland
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St. Gallen
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Taiwan
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Kaohsiung City
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Taiwan
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Kaohsiung
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Taiwan
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New Taipei City
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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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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Istanbul
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Izmir
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Turkey
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Kadiköy
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Turkey
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Malatya
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Ukraine
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Dnipropetrovsk
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kryvyi Rih
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Ukraine
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Sumy
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Ukraine
State/province [136] 0 0
Uzhgorod

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 the study is to evaluate the efficacy and safety of tiragolumab plus
atezolizumab compared with placebo plus atezolizumab in participants with previously
untreated locally advanced, unresectable or metastatic PD-L1-selected non-small cell lung
cancer (NSCLC), with no epidermal growth factor receptor (EGFR) mutation or anaplastic
lymphoma kinase (ALK) translocation. Eligible participants will be randomized in a 1:1 ratio
to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.
Trial website
https://clinicaltrials.gov/show/NCT04294810
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial
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: GO41717 www.roche.com/about_roche/roche_worldwide.htm
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/show/NCT04294810