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

Primary Purpose

Small Cell Lung Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tiragolumab
Atezolizumab
Carboplatin
Etoposide
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rocky Mountain Cancer Centers - Lone Tree
  • MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)
  • Florida Cancer Specialists; SCRI; Florida Cancer Specialists - Sarasota (Golf St)
  • SCRI Florida Cancer Specialists North; Research Office North Region.
  • Northwest Georgia Oncology Centers PC - Marietta
  • Illinois Cancer Care
  • New England Cancer Specialists
  • Weinberg Cancer Institution at Franklin Square
  • Minnesota Oncology Hematology
  • Comprehensive Cancer Centers of Nevada
  • Broome Oncology - Binghamton
  • Mount Sinai - PRIME; Icahn School of Medicine at Mount Sinai
  • Memorial Sloan Kettering Cancer Center
  • SCRI Tennessee Oncology Chattanooga
  • SARAH CANNON RESEARCH INST.; Tennessee Oncology, PLLC
  • Texas Oncology Cancer Center
  • Virginia Cancer Specialists
  • Blue Ridge Cancer Care
  • University of Wisconsin School of Medicine and Public Health
  • Chris O'Brien Lifehouse
  • Nepean Hospital; Nepean Cancer Care Centre
  • Sunshine Coast University Hospital; The Adem Crosby Centre
  • Lyell McEwin Hospital; Oncology Clinical Trials, Chemotherapy Day Unit
  • Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
  • Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten
  • Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie
  • AZ St Maarten Campus Leopoldstr
  • Clinique Ste-Elisabeth
  • AZ Delta (Campus Rumbeke)
  • Vitaz
  • Hospital Sao Rafael - HSR
  • Oncocentro Serviços Médicos e Hospitalares Ltda
  • Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia
  • Hospital Nossa Senhora da Conceicao
  • Clínica de Oncologia Reichow
  • Instituto do Cancer do Estado de Sao Paulo - ICESP
  • Fakultni nemocnice Olomouc; Pneumologicka klinika
  • Vitkovicka Nemocnice Bma, A.S.; Plicni Oddeleni
  • Thomayerova nemocnice; Pneumologicka klinika 1.LF UK TN
  • Helios Klinikum Emil von Behring GmbH
  • LungenClinic Großhansdorf GmbH
  • Asklepios Klinik Harburg
  • Fachklinik für Lungenerkrankungen
  • Universitätsklinikum Schleswig-Holstein; Campus Lübeck
  • Asklepios Klinik München-Gauting
  • General Hospital "G.Papanikolaou"; Pulmonogy Clinic
  • Uoa Sotiria Hospital; Oncology
  • Metropolitan General Hospital
  • Univ General Hosp Heraklion; Medical Oncology
  • Orszagos Koranyi TBC es Pulmonologiai Intezet
  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
  • Tudogyogyintezet Torokbalint
  • AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico
  • AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia
  • IRCCS Istituto Clinico Humanitas; Oncologia
  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga
  • Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
  • Azienda Ospedaliero-Universitaria ?PoliclinicoVittorio Emanuele?- P.O. G. Rodolico; Oncologia Medica
  • Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
  • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
  • National Cancer Center Hospital East
  • Kyushu University Hospital
  • Niigata Cancer Center Hospital
  • Osaka International Cancer Institute
  • Kindai University Hospital
  • Saitama Cancer Center
  • National Hospital Organization Kinki-Chuo Chest Medical Center
  • Shizuoka Cancer Center
  • National Cancer Center Hospital
  • The Cancer Institute Hospital of JFCR
  • Wakayama Medical University Hospital
  • Chungbuk National University Hospital
  • National Cancer Center
  • Samsung Changwon Hospital
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Samsung Medical Center
  • Seoul St Mary's Hospital
  • Ulsan University Hosiptal
  • Maastricht University Medical Center
  • Erasmus MC
  • Auckland City Hospital; Clinical Oncology
  • Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny
  • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
  • Krakowski Szpital Specjalistyczny im sw.Jana Pawla II
  • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
  • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
  • Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers
  • Principal Military Clinical Hospital n.a. N.N. Burdenko
  • BLOKHIN CANCER RESEARCH CENTER; CLINICAL ONCOLOGY; Clinical pharmacology and chemotheraphy
  • Scientific Research Institute n.a. N.N. Petrov
  • Clinical Center of Serbia; Clinic for Pulmonary Diseases
  • Clinical Hospital Center ''Bezanijska Kosa''; Department of Pulmology
  • Institute for Pulmonary Diseases of Vojvodina; Clinic for Pulmonary Oncology
  • National University Hospital; National University Cancer Institute, Singapore (NCIS)
  • National Cancer Centre; Medical Oncology
  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona
  • Hospital Clinic Barcelona; Servicio de oncologia
  • Fundacion Jimenez Diaz; Servicio de Oncologia
  • Hospital Universitario La Paz; Servicio de Oncologia
  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  • Hospital Clínico Universitario de Valencia; Servicio de Oncología
  • Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia
  • CHUV; Departement d'Oncologie
  • UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
  • National Cheng-Kung University Hospital
  • Taipei Veterans General Hospital
  • Chang-Gung Medical Foundation, Linkou Branch
  • National Taiwan University Hospital; Oncology
  • Adana Baskent University Hospital; Medical Oncology
  • Ankara University Medical Faculty; Medikal Onkoloji
  • Gazi University Medical Faculty
  • Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty; Medikal Onkoloji Departmani
  • Medipol University Medical Faculty; Oncology Department
  • ?zmir Medical Park; Onkoloji
  • NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital
  • Guys and St Thomas Hospital
  • Christie Foundation Trust
  • Royal Marsden Hospital (Sutton)
  • Royal Cornwall Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Placebo + Atezolizumab + CE

Tiragolumab + Atezolizumab + CE

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Investigator-Assessed Progression Free Survival (PFS) in the Primary Analysis Set (PAS)
Overall Survival (OS) in the PAS

Secondary Outcome Measures

PFS in the Full Analysis Set (FAS)
OS in the FAS
Investigator-Assessed Confirmed Objective Response Rate (ORR) in the PAS
Investigator-Assessed Confirmed ORR in the FAS
Investigator-Assessed Duration of Response (DOR) in the PAS
Investigator-Assessed DOR in the FAS
Investigator-Assessed PFS Rates at 6 Months and 12 Months in the PAS
Investigator-Assessed PFS Rates at 6 Months and 12 Months in the FAS
Overall Survival Rates at 12 Months and 24 Months in the PAS
Overall Survival Rates at 12 Months and 24 Months in the FAS
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
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.
TTCD Assessed Using EORTC QLQ-C30 Score in the FAS
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.
Percentage of Participants With Adverse Events
Minimum Serum Concentration (Cmin) of Tiragolumab
Cmin of Atezolizumab
Maximum Serum Concentration (Cmax) of Tiragolumab
Cmax of Atezolizumab
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab
Percentage of Participants With ADAs to Atezolizumab
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 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.

Full Information

First Posted
January 31, 2020
Last Updated
October 5, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04256421
Brief Title
A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Acronym
SKYSCRAPER-02
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 4, 2020 (Actual)
Primary Completion Date
September 6, 2022 (Actual)
Study Completion Date
March 21, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
490 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo + Atezolizumab + CE
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Tiragolumab + Atezolizumab + CE
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tiragolumab
Other Intervention Name(s)
MTIG7192A
Intervention Description
Tiragolumab 600 milligrams (mg) administered by IV infusion on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq
Intervention Description
Atezolizumab 1200 mg administered by IV infusion on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin was administered by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
Etoposide 100 mg/m^2 administered by IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered by IV infusion on Day 1 of each 21-day cycle.
Primary Outcome Measure Information:
Title
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)
Title
Overall Survival (OS) in the PAS
Time Frame
From randomization to death from any cause (up to 50 months)
Secondary Outcome Measure Information:
Title
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)
Title
OS in the FAS
Time Frame
From randomization to death from any cause (up to 50 months)
Title
Investigator-Assessed Confirmed Objective Response Rate (ORR) in the PAS
Time Frame
From randomization up to 50 months
Title
Investigator-Assessed Confirmed ORR in the FAS
Time Frame
From randomization up to 50 months
Title
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)
Title
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)
Title
Investigator-Assessed PFS Rates at 6 Months and 12 Months in the PAS
Time Frame
6 months, 12 months
Title
Investigator-Assessed PFS Rates at 6 Months and 12 Months in the FAS
Time Frame
6 months, 12 months
Title
Overall Survival Rates at 12 Months and 24 Months in the PAS
Time Frame
12 months, 24 months
Title
Overall Survival Rates at 12 Months and 24 Months in the FAS
Time Frame
12 months, 24 months
Title
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
Description
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.
Time Frame
From randomization until the first confirmed clinically meaningful deterioration up to 50 months
Title
TTCD Assessed Using EORTC QLQ-C30 Score in the FAS
Description
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.
Time Frame
From randomization until the first confirmed clinically meaningful deterioration up to 50 months
Title
Percentage of Participants With Adverse Events
Time Frame
Up to 50 months
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
Change from Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index-based and Visual Analog Scale Scores
Description
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.
Time Frame
From baseline up to 50 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Rocky Mountain Cancer Centers - Lone Tree
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Florida Cancer Specialists; SCRI; Florida Cancer Specialists - Sarasota (Golf St)
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
SCRI Florida Cancer Specialists North; Research Office North Region.
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Northwest Georgia Oncology Centers PC - Marietta
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Illinois Cancer Care
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
New England Cancer Specialists
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Weinberg Cancer Institution at Franklin Square
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Minnesota Oncology Hematology
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Broome Oncology - Binghamton
City
Binghamton
State/Province
New York
ZIP/Postal Code
13905
Country
United States
Facility Name
Mount Sinai - PRIME; Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
11101
Country
United States
Facility Name
SCRI Tennessee Oncology Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
SARAH CANNON RESEARCH INST.; Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Blue Ridge Cancer Care
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
University of Wisconsin School of Medicine and Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Nepean Hospital; Nepean Cancer Care Centre
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Sunshine Coast University Hospital; The Adem Crosby Centre
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4575
Country
Australia
Facility Name
Lyell McEwin Hospital; Oncology Clinical Trials, Chemotherapy Day Unit
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Facility Name
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie
City
Wien
ZIP/Postal Code
1210
Country
Austria
Facility Name
AZ St Maarten Campus Leopoldstr
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
Clinique Ste-Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
AZ Delta (Campus Rumbeke)
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Vitaz
City
Sint Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
Hospital Sao Rafael - HSR
City
Salvador
State/Province
BA
ZIP/Postal Code
41253-190
Country
Brazil
Facility Name
Oncocentro Serviços Médicos e Hospitalares Ltda
City
Fortaleza
State/Province
CE
ZIP/Postal Code
60130-241
Country
Brazil
Facility Name
Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia
City
Passo Fundo
State/Province
RS
ZIP/Postal Code
99010-260
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Clínica de Oncologia Reichow
City
Blumenau
State/Province
SC
ZIP/Postal Code
89010-340
Country
Brazil
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Fakultni nemocnice Olomouc; Pneumologicka klinika
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Vitkovicka Nemocnice Bma, A.S.; Plicni Oddeleni
City
Ostrava
ZIP/Postal Code
703 84
Country
Czechia
Facility Name
Thomayerova nemocnice; Pneumologicka klinika 1.LF UK TN
City
Praha 4 - Krc
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Helios Klinikum Emil von Behring GmbH
City
Berlin
ZIP/Postal Code
14165
Country
Germany
Facility Name
LungenClinic Großhansdorf GmbH
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Asklepios Klinik Harburg
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Facility Name
Fachklinik für Lungenerkrankungen
City
Immenhausen
ZIP/Postal Code
34376
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein; Campus Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Asklepios Klinik München-Gauting
City
München-Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
General Hospital "G.Papanikolaou"; Pulmonogy Clinic
City
Asvestochori
ZIP/Postal Code
570 10
Country
Greece
Facility Name
Uoa Sotiria Hospital; Oncology
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
Metropolitan General Hospital
City
Cholargos
ZIP/Postal Code
155 62
Country
Greece
Facility Name
Univ General Hosp Heraklion; Medical Oncology
City
Heraklion
ZIP/Postal Code
711 10
Country
Greece
Facility Name
Orszagos Koranyi TBC es Pulmonologiai Intezet
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Tudogyogyintezet Torokbalint
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia
City
Ravenna
State/Province
Emilia-Romagna
ZIP/Postal Code
48121
Country
Italy
Facility Name
IRCCS Istituto Clinico Humanitas; Oncologia
City
Rozzano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
City
Orbassano
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
Facility Name
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria ?PoliclinicoVittorio Emanuele?- P.O. G. Rodolico; Oncologia Medica
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
Facility Name
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
National Cancer Center Hospital East
City
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Kindai University Hospital
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Saitama Cancer Center
City
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
National Hospital Organization Kinki-Chuo Chest Medical Center
City
Sakai-shi
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
National Cancer Center Hospital
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Wakayama Medical University Hospital
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Samsung Changwon Hospital
City
Gyeongsangnam-do
ZIP/Postal Code
51353
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Seoul St Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Ulsan University Hosiptal
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Auckland City Hospital; Clinical Oncology
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny
City
Brzozów
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Krakowski Szpital Specjalistyczny im sw.Jana Pawla II
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
City
Olsztyn
ZIP/Postal Code
10-357
Country
Poland
Facility Name
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Principal Military Clinical Hospital n.a. N.N. Burdenko
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
BLOKHIN CANCER RESEARCH CENTER; CLINICAL ONCOLOGY; Clinical pharmacology and chemotheraphy
City
Moscow
State/Province
Moskovskaja Oblast
Country
Russian Federation
Facility Name
Scientific Research Institute n.a. N.N. Petrov
City
Saint Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
187758
Country
Russian Federation
Facility Name
Clinical Center of Serbia; Clinic for Pulmonary Diseases
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center ''Bezanijska Kosa''; Department of Pulmology
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Institute for Pulmonary Diseases of Vojvodina; Clinic for Pulmonary Oncology
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
National University Hospital; National University Cancer Institute, Singapore (NCIS)
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
National Cancer Centre; Medical Oncology
City
Singapore
ZIP/Postal Code
168583
Country
Singapore
Facility Name
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic Barcelona; Servicio de oncologia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Fundacion Jimenez Diaz; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario La Paz; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia; Servicio de Oncología
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
CHUV; Departement d'Oncologie
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
National Cheng-Kung University Hospital
City
Tainan
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Chang-Gung Medical Foundation, Linkou Branch
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
National Taiwan University Hospital; Oncology
City
Zhongzheng Dist.
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Adana Baskent University Hospital; Medical Oncology
City
Adana
ZIP/Postal Code
01120
Country
Turkey
Facility Name
Ankara University Medical Faculty; Medikal Onkoloji
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Gazi University Medical Faculty
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty; Medikal Onkoloji Departmani
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Medipol University Medical Faculty; Oncology Department
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Facility Name
?zmir Medical Park; Onkoloji
City
Izmir
Country
Turkey
Facility Name
NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Guys and St Thomas Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Christie Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Royal Marsden Hospital (Sutton)
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Truro
ZIP/Postal Code
TR1 3LQ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

Learn more about this trial

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

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