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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04256421




Registration number
NCT04256421
Ethics application status
Date submitted
31/01/2020
Date registered
5/02/2020
Date last updated
15/04/2024

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
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Colorado
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United States of America
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District of Columbia
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State/province [3] 0 0
Florida
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United States of America
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Georgia
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Illinois
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Maine
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Maryland
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Minnesota
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Nevada
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New York
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Tennessee
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Texas
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Virginia
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United States of America
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Wisconsin
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Austria
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Innsbruck
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Austria
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Wien
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Belgium
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Mechelen
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Belgium
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Namur
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Belgium
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Roeselare
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Belgium
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Sint Niklaas
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Brazil
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BA
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Brazil
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CE
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Brazil
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RS
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Brazil
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SC
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Brazil
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Olomouc
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Czechia
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Ostrava
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Czechia
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Praha 4 - Krc
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Germany
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Berlin
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Germany
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Gauting
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Germany
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Großhansdorf
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Germany
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Hamburg
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Germany
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Immenhausen
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Lübeck
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Asvestochori
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Greece
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Athens
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Cholargos
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Szolnok
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Campania
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Emilia-Romagna
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Italy
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Lombardia
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Italy
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Piemonte
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Italy
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Puglia
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Italy
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Sicilia
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Italy
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Toscana
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Veneto
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Chiba
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Fukuoka
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Niigata
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Osaka
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Saitama
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Japan
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Sakai-shi
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Shizuoka
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Tokyo
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Rotterdam
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Auckland
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Brzozów
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Gdansk
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Poznan
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Warszawa
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Russian Federation
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Moskovskaja Oblast
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Russian Federation
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Sankt Petersburg
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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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Singapore
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Barcelona
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Malaga
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Sevilla
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Spain
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Valencia
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Spain
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Zaragoza
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Switzerland
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Lausanne
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Switzerland
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Zürich
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Taiwan
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Tainan
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Taiwan
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Taipei City
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Taiwan
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Taoyuan
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Taiwan
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Zhongzheng Dist.
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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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Turkey
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Izmir
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United Kingdom
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Edinburgh
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Sutton
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United Kingdom
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Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the efficacy of tiragolumab plus atezolizumab and carboplatin and
etoposide (CE) compared with placebo plus atezolizumab and CE in participants with
chemotherapy-naive extensive-stage small cell lung cancer (ES-SCLC). Eligible participants
will be stratified by Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1),
LDH (</= upper limit of normal [ULN] vs. > ULN), and presence or history of brain metastasis
(yes vs. no) and randomly assigned in a 1:1 ratio to receive one of the following treatment
regimens during induction phase:

- Arm A: Tiragolumab plus atezolizumab plus CE

- Arm B: Placebo plus atezolizumab plus CE

Following the induction phase, participants will continue maintenance therapy with either
atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04256421
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/ct2/show/NCT04256421