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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04256421




Registration number
NCT04256421
Ethics application status
Date submitted
31/01/2020
Date registered
5/02/2020

Titles & IDs
Public title
A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Scientific title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab (Anti-Tigit Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Secondary ID [1] 0 0
2019-003301-97
Secondary ID [2] 0 0
GO41767
Universal Trial Number (UTN)
Trial acronym
SKYSCRAPER-02
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - Tiragolumab
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Etoposide
Treatment: Drugs - Placebo

Active comparator: Placebo + Atezolizumab + CE - Participants will receive atezolizumab on Day 1 of each 21-day cycle followed by placebo on Day 1 of each 21-day cycle. Carboplatin will be administered followed by etoposide on Day 1 for 4 cycles. Participants will also receive etoposide on Days 2 and 3.

Experimental: Tiragolumab + Atezolizumab + CE - Participants will receive atezolizumab on Day 1 of each 21-day cycle followed by tiragolumab on Day 1 of each 21-day cycle. Carboplatin will be administered followed by etoposide on Day 1 for 4 cycles. Participants will also receive etoposide on Days 2 and 3.


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

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

Treatment: Drugs: Carboplatin
Carboplatin was administered by IV infusion on Day 1 of each 21-day cycle for 4 cycles.

Treatment: Drugs: Etoposide
Etoposide 100 mg/m\^2 administered by IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles.

Treatment: Drugs: Placebo
Placebo administered by IV infusion 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 Analysis Set (PAS)
Timepoint [1] 0 0
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 50 months)
Primary outcome [2] 0 0
Overall Survival (OS) in the PAS
Timepoint [2] 0 0
From randomization to death from any cause (up to 50 months)
Secondary outcome [1] 0 0
PFS in the Full Analysis Set (FAS)
Timepoint [1] 0 0
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 50 months)
Secondary outcome [2] 0 0
OS in the FAS
Timepoint [2] 0 0
From randomization to death from any cause (up to 50 months)
Secondary outcome [3] 0 0
Investigator-Assessed Confirmed Objective Response Rate (ORR) in the PAS
Timepoint [3] 0 0
From randomization up to 50 months
Secondary outcome [4] 0 0
Investigator-Assessed Confirmed ORR in the FAS
Timepoint [4] 0 0
From randomization up to 50 months
Secondary outcome [5] 0 0
Investigator-Assessed Duration of Response (DOR) in the PAS
Timepoint [5] 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 50 months)
Secondary outcome [6] 0 0
Investigator-Assessed DOR in the FAS
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 50 months)
Secondary outcome [7] 0 0
Investigator-Assessed PFS Rates at 6 Months and 12 Months in the PAS
Timepoint [7] 0 0
6 months, 12 months
Secondary outcome [8] 0 0
Investigator-Assessed PFS Rates at 6 Months and 12 Months in the FAS
Timepoint [8] 0 0
6 months, 12 months
Secondary outcome [9] 0 0
Overall Survival Rates at 12 Months and 24 Months in the PAS
Timepoint [9] 0 0
12 months, 24 months
Secondary outcome [10] 0 0
Overall Survival Rates at 12 Months and 24 Months in the FAS
Timepoint [10] 0 0
12 months, 24 months
Secondary outcome [11] 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 PAS
Timepoint [11] 0 0
From randomization until the first confirmed clinically meaningful deterioration up to 50 months
Secondary outcome [12] 0 0
TTCD Assessed Using EORTC QLQ-C30 Score in the FAS
Timepoint [12] 0 0
From randomization until the first confirmed clinically meaningful deterioration up to 50 months
Secondary outcome [13] 0 0
Percentage of Participants With Adverse Events
Timepoint [13] 0 0
Up to 50 months
Secondary outcome [14] 0 0
Minimum Serum Concentration (Cmin) of Tiragolumab
Timepoint [14] 0 0
Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at treatment discontinuation (TD) visit (up to 50 months)
Secondary outcome [15] 0 0
Cmin of Atezolizumab
Timepoint [15] 0 0
Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to 50 months)
Secondary outcome [16] 0 0
Maximum Serum Concentration (Cmax) of Tiragolumab
Timepoint [16] 0 0
Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to 50 months)
Secondary outcome [17] 0 0
Cmax of Atezolizumab
Timepoint [17] 0 0
Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to 50 months)
Secondary outcome [18] 0 0
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab
Timepoint [18] 0 0
Predose on Day 1 of Cycles 1 (each cycle is 21 days), 2, 3, 4, 8,12 and 16 and at TD visit (up to 50 months)
Secondary outcome [19] 0 0
Percentage of Participants With ADAs to Atezolizumab
Timepoint [19] 0 0
Predose on Day 1 of Cycles 1 (each cycle is 21 days), 2, 3, 4, 8,12 and 16 and at TD visit (up to 50 months)
Secondary outcome [20] 0 0
Change from Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index-based and Visual Analog Scale Scores
Timepoint [20] 0 0
From baseline up to 50 months

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC)
* No prior systemic treatment for ES-SCLC
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
* Adequate hematologic and end-organ function
* Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Symptomatic or actively progressing central nervous system (CNS) metastases
* Malignancies other than small cell lung cancer (SCLC) within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
* 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 on screening chest computed tomography (CT) scan
* Positive test result for human immunodeficiency virus (HIV)
* Active hepatitis B or hepatitis C
* Severe infection at the time of randomization
* Treatment with any other investigational agent within 28 days prior to initiation of study treatment
* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-cytotoxic T lymphocyte-associated protein 4 (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 randomization

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/04/2026
Actual
Sample size
Target
Accrual to date
Final
490
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Nepean Hospital; Nepean Cancer Care Centre - Kingswood
Recruitment hospital [3] 0 0
Sunshine Coast University Hospital; The Adem Crosby Centre - Birtinya
Recruitment hospital [4] 0 0
Lyell McEwin Hospital; Oncology Clinical Trials, Chemotherapy Day Unit - Elizabeth Vale
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
4575 - Birtinya
Recruitment postcode(s) [4] 0 0
5112 - Elizabeth Vale
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Maine
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
United States of America
State/province [14] 0 0
Wisconsin
Country [15] 0 0
Austria
State/province [15] 0 0
Innsbruck
Country [16] 0 0
Austria
State/province [16] 0 0
Wien
Country [17] 0 0
Belgium
State/province [17] 0 0
Mechelen
Country [18] 0 0
Belgium
State/province [18] 0 0
Namur
Country [19] 0 0
Belgium
State/province [19] 0 0
Roeselare
Country [20] 0 0
Belgium
State/province [20] 0 0
Sint Niklaas
Country [21] 0 0
Brazil
State/province [21] 0 0
BA
Country [22] 0 0
Brazil
State/province [22] 0 0
CE
Country [23] 0 0
Brazil
State/province [23] 0 0
RS
Country [24] 0 0
Brazil
State/province [24] 0 0
SC
Country [25] 0 0
Brazil
State/province [25] 0 0
SP
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Czechia
State/province [26] 0 0
Olomouc
Country [27] 0 0
Czechia
State/province [27] 0 0
Ostrava
Country [28] 0 0
Czechia
State/province [28] 0 0
Praha 4 - Krc
Country [29] 0 0
Germany
State/province [29] 0 0
Berlin
Country [30] 0 0
Germany
State/province [30] 0 0
Gauting
Country [31] 0 0
Germany
State/province [31] 0 0
Großhansdorf
Country [32] 0 0
Germany
State/province [32] 0 0
Hamburg
Country [33] 0 0
Germany
State/province [33] 0 0
Immenhausen
Country [34] 0 0
Germany
State/province [34] 0 0
Lübeck
Country [35] 0 0
Greece
State/province [35] 0 0
Asvestochori
Country [36] 0 0
Greece
State/province [36] 0 0
Athens
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Greece
State/province [37] 0 0
Cholargos
Country [38] 0 0
Greece
State/province [38] 0 0
Heraklion
Country [39] 0 0
Hungary
State/province [39] 0 0
Budapest
Country [40] 0 0
Hungary
State/province [40] 0 0
Szolnok
Country [41] 0 0
Hungary
State/province [41] 0 0
Torokbalint
Country [42] 0 0
Italy
State/province [42] 0 0
Campania
Country [43] 0 0
Italy
State/province [43] 0 0
Emilia-Romagna
Country [44] 0 0
Italy
State/province [44] 0 0
Lombardia
Country [45] 0 0
Italy
State/province [45] 0 0
Piemonte
Country [46] 0 0
Italy
State/province [46] 0 0
Puglia
Country [47] 0 0
Italy
State/province [47] 0 0
Sicilia
Country [48] 0 0
Italy
State/province [48] 0 0
Toscana
Country [49] 0 0
Italy
State/province [49] 0 0
Veneto
Country [50] 0 0
Japan
State/province [50] 0 0
Chiba
Country [51] 0 0
Japan
State/province [51] 0 0
Fukuoka
Country [52] 0 0
Japan
State/province [52] 0 0
Niigata
Country [53] 0 0
Japan
State/province [53] 0 0
Osaka
Country [54] 0 0
Japan
State/province [54] 0 0
Saitama
Country [55] 0 0
Japan
State/province [55] 0 0
Sakai-shi
Country [56] 0 0
Japan
State/province [56] 0 0
Shizuoka
Country [57] 0 0
Japan
State/province [57] 0 0
Tokyo
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Japan
State/province [58] 0 0
Wakayama
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Cheongju-si
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Korea, Republic of
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Goyang-si
Country [61] 0 0
Korea, Republic of
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Gyeongsangnam-do
Country [62] 0 0
Korea, Republic of
State/province [62] 0 0
Seongnam-si
Country [63] 0 0
Korea, Republic of
State/province [63] 0 0
Seoul
Country [64] 0 0
Korea, Republic of
State/province [64] 0 0
Ulsan
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Netherlands
State/province [65] 0 0
Maastricht
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Netherlands
State/province [66] 0 0
Rotterdam
Country [67] 0 0
New Zealand
State/province [67] 0 0
Auckland
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Poland
State/province [68] 0 0
Brzozów
Country [69] 0 0
Poland
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Gdansk
Country [70] 0 0
Poland
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Krakow
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Poland
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Olsztyn
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Poland
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Otwock
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Poland
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Poznan
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Poland
State/province [74] 0 0
Warszawa
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Moskovskaja Oblast
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Sankt Petersburg
Country [77] 0 0
Serbia
State/province [77] 0 0
Belgrade
Country [78] 0 0
Serbia
State/province [78] 0 0
Sremska Kamenica
Country [79] 0 0
Singapore
State/province [79] 0 0
Singapore
Country [80] 0 0
Spain
State/province [80] 0 0
Barcelona
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Sevilla
Country [84] 0 0
Spain
State/province [84] 0 0
Valencia
Country [85] 0 0
Spain
State/province [85] 0 0
Zaragoza
Country [86] 0 0
Switzerland
State/province [86] 0 0
Lausanne
Country [87] 0 0
Switzerland
State/province [87] 0 0
Zürich
Country [88] 0 0
Taiwan
State/province [88] 0 0
Tainan
Country [89] 0 0
Taiwan
State/province [89] 0 0
Taipei City
Country [90] 0 0
Taiwan
State/province [90] 0 0
Taoyuan
Country [91] 0 0
Taiwan
State/province [91] 0 0
Zhongzheng Dist.
Country [92] 0 0
Turkey
State/province [92] 0 0
Adana
Country [93] 0 0
Turkey
State/province [93] 0 0
Ankara
Country [94] 0 0
Turkey
State/province [94] 0 0
Istanbul
Country [95] 0 0
Turkey
State/province [95] 0 0
Izmir
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Edinburgh
Country [97] 0 0
United Kingdom
State/province [97] 0 0
London
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Manchester
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Sutton
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Truro

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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?
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/members/ourmembers/). 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).
When will data be available (start and end dates)?
Available to whom?
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/NCT04256421