A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer (SKYSCRAPER-02)

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

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).

Study Overview

• Status: Completed
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: Tiragolumab; Drug: Atezolizumab; Drug: Carboplatin; Drug: Etoposide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 490
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Chris O'Brien Lifehouse
    • Kingswood, New South Wales, Australia, 2747
      • Nepean Hospital
  • Queensland
    • Birtinya, Queensland, Australia, 4575
      • Sunshine Coast University Hospital
  • South Australia
    • Elizabeth Vale, South Australia, Australia, 5112
      • Lyell McEwin Hospital
• Austria
  • Innsbruck, Austria, 6020
    • Tiroler Landeskrankenanstalten Ges.M.B.H.
  • Vienna, Austria, 1140
    • Klinik Penzing
  • Vienna, Austria, 1210
    • Krankenhaus Nord - Klinik Floridsdorf
• Belgium
  • Mechelen, Belgium, 2800
    • AZ St Maarten Campus Leopoldstr
  • Namur, Belgium, 5000
    • Clinique Ste-Elisabeth
  • Roeselare, Belgium, 8800
    • AZ Delta (Campus Rumbeke)
  • Sint-Niklaas, Belgium, 9100
    • Vitaz
• Brazil
  • Ceará
    • Fortaleza, Ceará, Brazil, 60130-241
      • Oncocentro Serviços Médicos e Hospitalares Ltda
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 41253-190
      • Hospital Sao Rafael - HSR
  • Rio Grande do Sul
    • Passo Fundo, Rio Grande do Sul, Brazil, 99010-260
      • Hospital de Clínicas de Passo Fundo
    • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
      • Hospital Nossa Senhora da Conceição
  • Santa Catarina
    • Blumenau, Santa Catarina, Brazil, 89010-340
      • Clínica de Oncologia Reichow
  • São Paulo
    • São Paulo, São Paulo, Brazil, 01246-000
      • Instituto do Cancer do Estado de Sao Paulo - ICESP
• Czechia
  • Olomouc, Czechia, 775 20
    • Fakultni nemocnice Olomouc
  • Ostrava, Czechia, 703 84
    • Vitkovicka Nemocnice Bma, A.S.
  • Praha 4 - Krc, Czechia, 140 59
    • Thomayerova nemocnice
• Germany
  • Berlin, Germany, 14165
    • Helios Klinikum Emil von Behring GmbH
  • Großhansdorf, Germany, 22927
    • LungenClinic Großhansdorf GmbH
  • Hamburg, Germany, 21075
    • Asklepios Klinik Harburg
  • Immenhausen, Germany, 34376
    • Fachklinik für Lungenerkrankungen
  • Lübeck, Germany, 23538
    • Universitatsklinikum Schleswig-Holstein
  • München-Gauting, Germany, 82131
    • Asklepios Klinik Gauting
• Greece
  • Asvestochóri, Greece, 570 10
    • General Hospital "G.Papanikolaou"
  • Athens, Greece, 115 27
    • Uoa Sotiria Hospital
  • Cholargós, Greece, 155 62
    • Metropolitan General Hospital
  • Heraklion, Greece, 711 10
    • Univ General Hosp Heraklion
• Hungary
  • Budapest, Hungary, 1121
    • Orszagos Koranyi Tbc es Pulmonologiai Intezet
  • Szolnok, Hungary, 5000
    • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
  • Törökbálint, Hungary, 2045
    • Tudogyogyintezet Torokbalint
• Italy
  • Apulia
    • Bari, Apulia, Italy, 70124
      • Irccs Ist. Tumori Giovanni Paolo Ii
  • Campania
    • Naples, Campania, Italy, 80131
      • AORN Ospedali dei Colli Ospedale Monaldi
  • Emilia-Romagna
    • Ravenna, Emilia-Romagna, Italy, 48121
      • AUSL della Romagna
  • Lombardy
    • Rozzano, Lombardy, Italy, 20089
      • IRCCS Istituto Clinico Humanitas
  • Piedmont
    • Orbassano, Piedmont, Italy, 10043
      • Azienda Sanitaria Ospedaliera S Luigi Gonzaga
  • Sicily
    • Catania, Sicily, Italy, 95123
      • Azienda Ospedaliero-Universitaria ?PoliclinicoVittorio Emanuele?- P.O. G. Rodolico
  • Veneto
    • Padova, Veneto, Italy, 35128
      • IRCCS Istituto Oncologico Veneto (IOV)
• Japan
  • Chiba, Japan, 277-8577
    • National Cancer Center Hospital East
  • Fukuoka, Japan, 812-8582
    • Kyushu University Hospital
  • Niigata, Japan, 951-8566
    • Niigata Cancer Center Hospital
  • Osaka, Japan, 589-8511
    • Kindai University Hospital
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute
  • Osaka, Japan, 591-8555
    • NHO Kinki-Chuo Chest Medical Center
  • Saitama, Japan, 362-0806
    • Saitama Cancer Center
  • Shizuoka, Japan, 411-8777
    • Shizuoka Cancer Center
  • Tokyo, Japan, 104-0045
    • National Cancer Center Hospital
  • Tokyo, Japan, 135-8550
    • The Cancer Institute Hospital of JFCR
  • Wakayama, Japan, 641-8510
    • Wakayama Medical University Hospital
• Netherlands
  • Maastricht, Netherlands, 6229 HX
    • Maastricht University Medical Center
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus MC
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital
• Poland
  • Brzozów, Poland, 36-200
    • Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny
  • Gdansk, Poland, 80-214
    • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
  • Krakow, Poland, 31-202
    • Krakowski Szpital Specjalistyczny im sw.Jana Pawla II
  • Olsztyn, Poland, 10-357
    • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
  • Otwock, Poland, 05-400
    • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
  • Poznan, Poland, 60-569
    • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
  • Warsaw, Poland, 02-781
    • Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
• Russia
  • Moscow Oblast
    • Moscow, Moscow Oblast, Russia, 105229
      • Principal Military Clinical Hospital n.a. N.N. Burdenko
    • Moscow, Moscow Oblast, Russia
      • Blokhin Cancer Research Center
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 187758
      • Scientific Research Institute n.a. N.N. Petrov
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Center of Serbia
  • Belgrade, Serbia, 11080
    • Clinical Hospital Center ''Bezanijska Kosa''
  • Kamenitz, Serbia, 21204
    • Institute for Pulmonary Diseases of Vojvodina
• Singapore
  • Singapore, Singapore, 119228
    • National University Hospital
  • Singapore, Singapore, 168583
    • National Cancer Centre
• South Korea
  • Cheongju-si, South Korea, 28644
    • Chungbuk National University Hospital
  • Gyeonggi-do, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Gyeonggi-do, South Korea, 10408
    • National Cancer Center
  • Gyeongsangnam-do, South Korea, 51353
    • Samsung Changwon Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 06591
    • Seoul St Mary's Hospital
  • Ulsan, South Korea, 44033
    • Ulsan University Hosiptal
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic Barcelona
  • Barcelona, Spain, 08035
    • Vall d?Hebron Institute of Oncology (VHIO), Barcelona
  • Madrid, Spain, 28040
    • Fundación Jimenez Díaz
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Málaga, Spain, 29010
    • Hospital Clinico Universitario Virgen de la Victoria
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia
  • Zaragoza, Spain, 50009
    • Hospital Clínico Universitario Lozano Blesa
• Switzerland
  • Lausanne, Switzerland, 1011
    • CHUV
  • Zurich, Switzerland, 8091
    • Universitätsspital Zürich
• Taiwan
  • Tainan, Taiwan, 70401
    • National Cheng-Kung University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taoyuan District, Taiwan, 333
    • Chang-Gung Medical Foundation, Linkou Branch
  • Zhongzheng Dist., Taiwan, 10048
    • National Taiwan University Hospital
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01120
    • Adana Baskent University Hospital
  • Ankara, Turkey (Türkiye), 06500
    • Gazi University Medical Faculty
  • Ankara, Turkey (Türkiye), 06100
    • Ankara University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34214
    • Medipol University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34098
    • Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty
  • Izm?r, Turkey (Türkiye), 35575
    • ?zmir Medical Park
• United Kingdom
  • Edinburgh, United Kingdom, EH4 2XU
    • NHS Lothian - Western General Hospital
  • London, United Kingdom, SE1 9RT
    • Guys and St Thomas Hospital
  • Manchester, United Kingdom, M20 4BX
    • Christie Foundation Trust
  • Truro, United Kingdom, TR1 3LQ
    • Royal Cornwall Hospital
• United States
  • Colorado
    • Lone Tree, Colorado, United States, 80124
      • Rocky Mountain Cancer Centers - Lone Tree
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialists
    • Sarasota, Florida, United States, 34232
      • SCRI Florida Cancer Specialists North
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Northwest Georgia Oncology Centers PC - Marietta
  • Illinois
    • Peoria, Illinois, United States, 61615
      • Illinois Cancer Care
  • Maine
    • Scarborough, Maine, United States, 04074
      • New England Cancer Specialists
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Weinberg Cancer Institution at Franklin Square
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Minnesota Oncology Hematology
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Comprehensive Cancer Centers of Nevada
  • New York
    • Binghamton, New York, United States, 13905
      • Broome Oncology - Binghamton
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Sarah Cannon Research Institute / Tennessee Oncology
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Inst.
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Oncology Cancer Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists
    • Roanoke, Virginia, United States, 24014
      • Blue Ridge Cancer Care
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin School of Medicine and Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Tiragolumab; Tiragolumab 600 milligrams (mg) administered by IV infusion on Day 1 of each 21-day cycle.; Other Names: MTIG7192A; Drug: Atezolizumab; Atezolizumab 1200 mg administered by IV infusion on Day 1 of each 21-day cycle.; Other Names: Tecentriq; Drug: Carboplatin; Carboplatin was administered by IV infusion on Day 1 of each 21-day cycle for 4 cycles.; Drug: Etoposide; Etoposide 100 mg/m^2 administered by IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles.
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.	Drug: Atezolizumab; Atezolizumab 1200 mg administered by IV infusion on Day 1 of each 21-day cycle.; Other Names: Tecentriq; Drug: Carboplatin; Carboplatin was administered by IV infusion on Day 1 of each 21-day cycle for 4 cycles.; Drug: Etoposide; Etoposide 100 mg/m^2 administered by IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles.; Drug: Placebo; Placebo administered by IV infusion on Day 1 of each 21-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) in the PAS	OS was defined as the time from randomization to death from any cause.	From randomization to death from any cause (up to approximately 24 months)
Investigator-assessed Progression-free Survival (PFS) in the Primary Analysis Set (PAS)	PFS was defined as the time from randomization to the first documented PD as determined by the investigator with the use of Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD on study (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 millimeters (mm).	From randomization to the first occurrence of PD or death from any cause, whichever occurred first (up to approximately 24 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS in the FAS	OS was defined as the time from randomization to death from any cause.	From randomization to death from any cause (up to approximately 24 months)
PFS in the FAS	PFS was defined as the time from randomization to the first documented PD as determined by the investigator with the use of RECIST v1.1 or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm.	From randomization to the first occurrence of PD or death from any cause, whichever occurred first (up to approximately 24 months)
Investigator-assessed Confirmed Objective Response Rate (ORR) in the PAS	ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) as determined by the investigator with the use of RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off.	From randomization up to approximately 24 months
Investigator-assessed Confirmed ORR in the FAS	ORR was defined as the percentage of participants with CR or PR as determined by the investigator with the use of RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off.	From randomization up to approximately 24 months
Investigator-assessed Duration of Response (DOR) in the PAS	DOR was defined as the time from the first occurrence of a documented OR (CR or PR) to PD or death from any cause, whichever occurred first, as determined by the investigator with the use of RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm.	From the first occurrence of a documented confirmed objective response (OR) to PD or death from any cause, whichever occurred first (up to approximately 24 months)
Investigator-assessed DOR in the FAS	DOR was defined as the time from the first occurrence of a documented OR (CR or PR) to PD or death from any cause, whichever occurred first, as determined by the investigator with the use of RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm.	From the first occurrence of a documented confirmed OR to PD or death from any cause, whichever occurred first (up to approximately 24 months)
Investigator-assessed PFS Rates at 6 Months and 12 Months in the PAS	PFS rate at 6 months and 12 months was defined as the percentage of participants who were event-free at these specific time points. Percentages have been rounded off to the nearest decimal point. A point estimate of the event-free rate was a single, numerical value used to approximate the true event-free rate of the entire population at a specific point in time. This value was calculated from ordered data (Event, Censoring) of each participant, using the Kaplan-Meier (K-M) method, accounting for censored observations (so event-free rates may not directly be calculated based only on participants remaining at risk).	Month 6, Month 12
Investigator-assessed PFS Rates at 6 Months and 12 Months in the FAS	PFS rate at 6 months and 12 months was defined as the percentage of participants who were event-free at these specific time points. Percentages have been rounded off to the nearest decimal point. A point estimate of the event-free rate was a single, numerical value used to approximate the true event-free rate of the entire population at a specific point in time. This value was calculated from ordered data (Event, Censoring) of each participant, using the K-M method, accounting for censored observations (so event-free rates may not directly be calculated based only on participants remaining at risk).	Month 6, Month 12
OS Rates at 12 Months and 24 Months in the PAS	OS rate at 12 months and 24 months was defined as the percentage of participants who were alive at these specific time points. Percentages have been rounded off to the nearest decimal point. A point estimate of the event-free rate was a single, numerical value used to approximate the true event-free rate of the entire population at a specific point in time. This value was calculated from ordered data (Event, Censoring) of each participant, using the K-M method, accounting for censored observations (so event-free rates may not directly be calculated based only on participants remaining at risk).	Month 12, Month 24
OS Rates at 12 Months and 24 Months in the FAS	OS rate at 12 months and 24 months was defined as the percentage of participants who were alive at these specific time points. Percentages have been rounded off to the nearest decimal point. A point estimate of the event-free rate was a single, numerical value used to approximate the true event-free rate of the entire population at a specific point in time. This value was calculated from ordered data (Event, Censoring) of each participant, using the K-M method, accounting for censored observations (so event-free rates may not directly be calculated based only on participants remaining at risk).	Month 12, Month 24
Time to Confirmed Deterioration (TTCD) of European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (PF) in the PAS	TTCD was the time from randomization until the first confirmed clinically meaningful deterioration in PF. TTCD was determined based on patient-reported PF (Items 1-5) as collected and measured by the EORTC QLQ-C30. The PF was measured on 4-point scale (1='Not at all' to 4='Very much'). A high score for the PF subscale represented a high/healthy level of functioning. The scale was linearly transformed so that each score ranged from 0 to 100. A score change of at least 10-point in PF subscale score was perceived by participants as clinically meaningful. Confirmed clinically meaningful deterioration was defined as a clinically meaningful decrease from baseline that was held for at least two consecutive assessments or an initial clinically meaningful decrease from baseline followed by death from any cause within 3 weeks.	From randomization until the first confirmed clinically meaningful deterioration (up to approximately 24 months)
TTCD of EORTC QLQ-C30 Physical Functioning in the FAS	TTCD was the time from randomization until the first confirmed clinically meaningful deterioration in PF. TTCD was determined based on patient-reported PF (Items 1-5) as collected and measured by the EORTC QLQ-C30. The PF was measured on 4-point scale (1='Not at all' to 4='Very much'). A high score for the PF subscale represented a high/healthy level of functioning. The scale was linearly transformed so that each score ranged from 0 to 100. A score change of at least 10-point in PF subscale score was perceived by participants as clinically meaningful. Confirmed clinically meaningful deterioration was defined as a clinically meaningful decrease from baseline that was held for at least two consecutive assessments or an initial clinically meaningful decrease from baseline followed by death from any cause within 3 weeks.	From randomization until the first confirmed clinically meaningful deterioration (up to approximately 24 months)
TTCD of EORTC QLQ-C30 Global Health Status (GHS)/Quality-of-life (QoL) in the PAS	TTCD was the time from randomization until the first confirmed clinically meaningful deterioration in patient-reported GHS/QoL. TTCD was determined based on patient-reported GHS/QoL (Items 29-30) as collected and measured by the EORTC QLQ-C30. GHS/QoL items were scored on a 7-point scale, ranging from "very poor" to "excellent". A high score for the GHS/QoL subscale represented a high health-related QoL. The scale was linearly transformed so that each score ranged from 0 to 100. A score change of at least 10-point in GHS/QoL subscale score was perceived by participants as clinically meaningful. Confirmed clinically meaningful deterioration was defined as a clinically meaningful decrease from baseline that was held for at least two consecutive assessments or an initial clinically meaningful decrease from baseline followed by death from any cause within 3 weeks.	From randomization until the first confirmed clinically meaningful deterioration (up to approximately 24 months)
TTCD of EORTC QLQ-C30 GHS/QoL in the FAS	TTCD was the time from randomization until the first confirmed clinically meaningful deterioration in patient-reported GHS/QoL. TTCD was determined based on patient-reported GHS/QoL (Items 29-30) as collected and measured by the EORTC QLQ-C30. GHS/QoL items were scored on a 7-point scale, ranging from "very poor" to "excellent". A high score for the GHS/QoL subscale represented a high health-related QoL. The scale was linearly transformed so that each score ranged from 0 to 100. A score change of at least 10-point in GHS/QoL subscale score was perceived by participants as clinically meaningful. Confirmed clinically meaningful deterioration was defined as a clinically meaningful decrease from baseline that was held for at least two consecutive assessments or an initial clinically meaningful decrease from baseline followed by death from any cause within 3 weeks.	From randomization until the first confirmed clinically meaningful deterioration (up to approximately 24 months)
Number of Participants With Adverse Events (AEs)	An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study were also considered as AEs.	Up to 58 months
Number of Participants With Severity of Cytokine-release Syndrome (CRS), as Determined by the American Society for Transplantation and Cell Therapy (ASTCT) Consensus Grading Scale	CRS=supraphysiologic response following administration of any immune therapy that results in activation/engagement of endogenous or infused T cells and/or other immune effector cells. Symptoms may be progressive, including fever at onset, and may also include hypotension, capillary leak (hypoxia), and end-organ dysfunction. Severity of CRS was determined per ASTCT Consensus Grading Criteria, which categorizes CRS into 5 grades: Grade 1: Fever (≥38◦Celsius), with/without constitutional symptoms, in absence of hypotension & hypoxia; Grade 2: Fever with hypotension not requiring vasopressors and/or hypoxia requiring low-flow oxygen; Grade 3: Fever with hypotension requiring one vasopressor, with/without vasopressin, and/or hypoxia requiring high-flow oxygen; Grade 4: Fever accompanied by hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring positive-pressure ventilation; Grade 5: death due to CRS. Only non zero values have been reported.	Up to 58 months
Minimum Serum Concentration (Cmin) of Tiragolumab		At the end of Cycles 1, 2, 3, 7, 11 and 15 (approximately 11 months) (1 Cycle=21 days)
Cmin of Atezolizumab		At the end of each Cycles 1, 2, 3, 7, 11 and 15 (approximately 11 months) (1 Cycle=21 days)
Maximum Serum Concentration (Cmax) of Tiragolumab		Pre-dose and 30 minutes post end of infusion (EOI) on Day 1 of Cycle 1 (1 Cycle=21 days)
Cmax of Atezolizumab		Pre-dose and 30 minutes post EOI on Day 1 of Cycle 1 (1 Cycle=21 days)
Number of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab	Participants were considered to be ADA-positive if they were ADA-negative at baseline but developed an ADA response following tiragolumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such at least 0.60 titer unit (t.u.) greater than the baseline titer result (treatment-enhanced ADA response). The total number of participants who developed ADAs to tiragolumab was determined by summing the ADA-positive participants across all timepoints.	Pre-dose on Day 1 of Cycles 1, 2, 3, 4, 8,12, 16 and at treatment discontinuation (TD) visit (up to 24 months) (1 Cycle=21 days)
Number of Participants With ADAs to Atezolizumab	Participants were considered to be ADA-positive if they were ADA-negative at baseline but developed an ADA response following atezolizumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such at least 0.60 t.u. greater than the baseline titer result (treatment-enhanced ADA response). The total number of participants who developed ADAs to tiragolumab was determined by summing the ADA-positive participants across all timepoints.	Pre-dose on Day 1 of Cycles 1, 2, 3, 4, 8,12, 16 and at TD visit (up to 24 months) (1 Cycle=21 days)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in EuroQol 5-dimension, 5-level (EQ-5D-5L) Index-based and Visual Analog Scale Scores	The EQ-5D-5L is a validated self-report health status questionnaire that was used to calculate a health status utility score for use in health economic analyses. There were two components to the EQ-5D-5L: a five-item health state profile that assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a visual analog scale (VAS) that measured health state. The EQ VAS records the participant's self-rated health on a vertical visual analogue scale ranging from 0 to 100. A single composite score was calculated based on the responses as an indicator of the participant's health status. The scale ranges 0-100, 0=worst health and 100=best health.	Pre-dose; Day 1 of Cycles 1, 2, 3, and 4

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

General Publications

• Rudin CM, Liu SV, Soo RA, Lu S, Hong MH, Lee JS, Bryl M, Dumoulin DW, Rittmeyer A, Chiu CH, Ozyilkan O, Johnson M, Navarro A, Novello S, Ozawa Y, Tam SH, Patil NS, Wen X, Huang M, Hoang T, Meng R, Reck M. SKYSCRAPER-02: Tiragolumab in Combination With Atezolizumab Plus Chemotherapy in Untreated Extensive-Stage Small-Cell Lung Cancer. J Clin Oncol. 2024 Jan 20;42(3):324-335. doi: 10.1200/JCO.23.01363. Epub 2023 Nov 17.

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2020
• Primary Completion (Actual): September 6, 2022
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Small Cell Lung Carcinoma; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glucosides; Glycosides; Coordination Complexes; Etoposide; Carboplatin; atezolizumab; Tiragolumab
• Other Study ID Numbers: GO41767; 2019-003301-97 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No