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

January 17, 2024 updated by: Hoffmann-La Roche

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

Study Type

Interventional

Enrollment (Actual)

490

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Chris O'Brien Lifehouse
      • Kingswood, New South Wales, Australia, 2747
        • Nepean Hospital; Nepean Cancer Care Centre
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Sunshine Coast University Hospital; The Adem Crosby Centre
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Lyell McEwin Hospital; Oncology Clinical Trials, Chemotherapy Day Unit
      • Innsbruck, Austria, 6020
        • Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
      • Wien, Austria, 1210
        • Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie
      • Wien, Austria, 1140
        • Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten
      • 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
    • BA
      • Salvador, BA, Brazil, 41253-190
        • Hospital Sao Rafael - HSR
    • CE
      • Fortaleza, CE, Brazil, 60130-241
        • Oncocentro Servicos Medicos e Hospitalares Ltda
    • RS
      • Passo Fundo, RS, Brazil, 99010-260
        • Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia
      • Porto Alegre, RS, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceicao
    • SC
      • Blumenau, SC, Brazil, 89010-340
        • Clinica de Oncologia Reichow
    • SP
      • Sao Paulo, SP, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP
      • Olomouc, Czechia, 779 00
        • Fakultni nemocnice Olomouc; Pneumologicka klinika
      • Ostrava, Czechia, 703 84
        • Vitkovicka Nemocnice Bma, A.S.; Plicni Oddeleni
      • Praha 4 - Krc, Czechia, 140 59
        • Thomayerova nemocnice; Pneumologicka klinika 1.LF UK TN
      • Berlin, Germany, 14165
        • Helios Klinikum Emil von Behring GmbH
      • Gauting, Germany, 82131
        • Asklepios Klinik Gauting; Onkologisches Studienzentrum
      • Großhansdorf, Germany, 22927
        • LungenClinic Grosshansdorf GmbH
      • Hamburg, Germany, 21075
        • Asklepios Klinik Harburg
      • Immenhausen, Germany, 34376
        • Fachklinik für Lungenerkrankungen
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein; Campus Lübeck
      • Asvestochori, Greece, 570 10
        • General Hospital "G.Papanikolaou"; Pulmonogy Clinic
      • Athens, Greece, 115 27
        • Uoa Sotiria Hospital; Oncology
      • Cholargos, Greece, 155 62
        • Metropolitan General Hospital
      • Heraklion, Greece, 711 10
        • Univ General Hosp Heraklion; Medical Oncology
      • Budapest, Hungary, 1121
        • Orszagos Koranyi Tbc es Pulmonologiai Intezet
      • Szolnok, Hungary, 5000
        • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
      • Torokbalint, Hungary, 2045
        • Tudogyogyintezet Torokbalint
    • Campania
      • Napoli, Campania, Italy, 80131
        • AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico
    • Emilia-Romagna
      • Ravenna, Emilia-Romagna, Italy, 48121
        • AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia
    • Lombardia
      • Rozzano (MI), Lombardia, Italy, 20089
        • IRCCS Istituto Clinico Humanitas; Oncologia
    • Piemonte
      • Orbassano, Piemonte, Italy, 10043
        • Azienda Sanitaria Ospedaliera S Luigi Gonzaga
    • Puglia
      • Bari, Puglia, Italy, 70124
        • Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
    • Sicilia
      • Catania, Sicilia, Italy, 95123
        • Azienda Ospedaliero-Universitaria ?PoliclinicoVittorio Emanuele?- P.O. G. Rodolico; Oncologia Medica
    • Toscana
      • Siena, Toscana, Italy, 53100
        • Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
    • Veneto
      • Padova, Veneto, Italy, 35128
        • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
      • 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
      • Saitama, Japan, 362-0806
        • Saitama Cancer Center
      • Sakai-shi, Japan, 591-8555
        • National Hospital Organization Kinki-chuo Chest Medical 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
      • Cheongju-si, Korea, Republic of, 28644
        • Chungbuk National University Hospital
      • Goyang-si, Korea, Republic of, 10408
        • National Cancer Center
      • Gyeongsangnam-do, Korea, Republic of, 51353
        • Samsung Changwon Hospital
      • Seongnam-si, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 06591
        • Seoul St Mary's Hospital
      • Ulsan, Korea, Republic of, 44033
        • Ulsan University Hosiptal
      • Maastricht, Netherlands, 6229 HX
        • Maastricht University Medical Center
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus MC
      • Auckland, New Zealand, 1023
        • Auckland City Hospital; Clinical Oncology
      • 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; Oddzial onkologii z pododdzialem chemioterapii
      • Otwock, Poland, 05-400
        • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
      • Poznan, Poland, 60-569
        • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
      • Warszawa, Poland, 02-781
        • Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers
    • Moskovskaja Oblast
      • Moscow, Moskovskaja Oblast, Russian Federation, 105229
        • Principal Military Clinical Hospital n.a. N.N. Burdenko
      • Moscow, Moskovskaja Oblast, Russian Federation
        • BLOKHIN CANCER RESEARCH CENTER; CLINICAL ONCOLOGY; Clinical pharmacology and chemotheraphy
    • Sankt Petersburg
      • Saint Petersburg, Sankt Petersburg, Russian Federation, 187758
        • Scientific Research Institute n.a. N.N. Petrov
      • Belgrade, Serbia, 11000
        • Clinical Center of Serbia; Clinic for Pulmonary Diseases
      • Belgrade, Serbia, 11080
        • Clinical Hospital Center ''Bezanijska Kosa''; Department of Pulmology
      • Sremska Kamenica, Serbia, 21204
        • Institute for Pulmonary Diseases of Vojvodina; Clinic for Pulmonary Oncology
      • Singapore, Singapore, 119228
        • National University Hospital; National University Cancer Institute, Singapore (NCIS)
      • Singapore, Singapore, 168583
        • National Cancer Centre; Medical Oncology
      • Barcelona, Spain, 08036
        • Hospital Clinic Barcelona; Servicio de oncologia
      • Barcelona, Spain, 08035
        • Vall d?Hebron Institute of Oncology (VHIO), Barcelona
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz; Servicio de Oncologia
      • Madrid, Spain, 28040
        • Fundacion Jimenez Diaz; Servicio de Oncologia
      • Malaga, Spain, 29010
        • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia; Servicio de Oncología
      • Zaragoza, Spain, 50009
        • Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia
      • Lausanne, Switzerland, 1011
        • CHUV; Departement d'Oncologie
      • Zürich, Switzerland, 8091
        • UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
      • Tainan, Taiwan
        • National Cheng-Kung University Hospital
      • Taipei City, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taoyuan, Taiwan, 333
        • Chang-Gung Medical Foundation, Linkou Branch
      • Zhongzheng Dist., Taiwan, 10048
        • National Taiwan University Hospital; Oncology
      • Adana, Turkey, 01120
        • Adana Baskent University Hospital; Medical Oncology
      • Ankara, Turkey, 06100
        • Ankara University Medical Faculty; Medikal Onkoloji
      • Ankara, Turkey, 06500
        • Gazi University Medical Faculty
      • Istanbul, Turkey, 34214
        • Medipol University Medical Faculty; Oncology Department
      • Istanbul, Turkey, 34098
        • Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty; Medikal Onkoloji Departmani
      • Izmir, Turkey
        • ?zmir Medical Park; Onkoloji
      • Edinburgh, United Kingdom, EH4 2XU
        • NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital
      • London, United Kingdom, SE1 9RT
        • Guys and St Thomas Hospital
      • Manchester, United Kingdom, M20 4BX
        • Christie Foundation Trust
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Hospital (Sutton)
      • Truro, United Kingdom, TR1 3LQ
        • Royal Cornwall Hospital
    • Colorado
      • Lone Tree, Colorado, United States, 80124
        • Rocky Mountain Cancer Centers - Lone Tree
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists; SCRI; Florida Cancer Specialists - Sarasota (Golf St)
      • Saint Petersburg, Florida, United States, 33705
        • SCRI Florida Cancer Specialists North; Research Office North Region.
    • 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
      • Saint Paul, Minnesota, United States, 55102
        • Minnesota Oncology Hematology
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Comprehensive Cancer Centers of Nevada
    • New York
      • Binghamton, New York, United States, 13905
        • Broome Oncology - Binghamton
      • New York, New York, United States, 11101
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10029
        • Mount Sinai - PRIME; Icahn School of Medicine at Mount Sinai
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • SCRI Tennessee Oncology Chattanooga
      • Nashville, Tennessee, United States, 37203
        • SARAH CANNON RESEARCH INST.; Tennessee Oncology, PLLC
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Investigator-Assessed Progression Free Survival (PFS) in the Primary Analysis Set (PAS)
Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 50 months)
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 50 months)
Overall Survival (OS) in the PAS
Time Frame: From randomization to death from any cause (up to 50 months)
From randomization to death from any cause (up to 50 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS in the Full Analysis Set (FAS)
Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 50 months)
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 50 months)
OS in the FAS
Time Frame: From randomization to death from any cause (up to 50 months)
From randomization to death from any cause (up to 50 months)
Investigator-Assessed Confirmed Objective Response Rate (ORR) in the PAS
Time Frame: From randomization up to 50 months
From randomization up to 50 months
Investigator-Assessed Confirmed ORR in the FAS
Time Frame: From randomization up to 50 months
From randomization up to 50 months
Investigator-Assessed PFS Rates at 6 Months and 12 Months in the PAS
Time Frame: 6 months, 12 months
6 months, 12 months
Investigator-Assessed PFS Rates at 6 Months and 12 Months in the FAS
Time Frame: 6 months, 12 months
6 months, 12 months
Overall Survival Rates at 12 Months and 24 Months in the PAS
Time Frame: 12 months, 24 months
12 months, 24 months
Overall Survival Rates at 12 Months and 24 Months in the FAS
Time Frame: 12 months, 24 months
12 months, 24 months
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
Time Frame: From randomization until the first confirmed clinically meaningful deterioration up to 50 months
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.
From randomization until the first confirmed clinically meaningful deterioration up to 50 months
TTCD Assessed Using EORTC QLQ-C30 Score in the FAS
Time Frame: From randomization until the first confirmed clinically meaningful deterioration up to 50 months
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.
From randomization until the first confirmed clinically meaningful deterioration up to 50 months
Percentage of Participants With Adverse Events
Time Frame: Up to 50 months
Up to 50 months
Cmin of Atezolizumab
Time Frame: 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)
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)
Maximum Serum Concentration (Cmax) of Tiragolumab
Time Frame: 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)
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)
Cmax of Atezolizumab
Time Frame: 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)
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)
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab
Time Frame: 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)
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)
Percentage of Participants With ADAs to Atezolizumab
Time Frame: 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)
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)
Change from Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index-based and Visual Analog Scale Scores
Time Frame: From baseline up to 50 months
The EQ-5D-5L is a validated self-report health status questionnaire that is used to calculate a health status utility score for use in health economic analyses. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a visual analog scale (VAS) that measures health state. A single composite score is calculated based on the responses as an indicator of the participant's health status.
From baseline up to 50 months
Investigator-Assessed Duration of Response (DOR) in the PAS
Time Frame: 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)
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)
Investigator-Assessed DOR in the FAS
Time Frame: 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)
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)
Minimum Serum Concentration (Cmin) of Tiragolumab
Time Frame: 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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2020

Primary Completion (Actual)

September 6, 2022

Study Completion (Estimated)

April 15, 2026

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)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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