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A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC) (IMpower133)

Primary Purpose

Small Cell Lung Carcinoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
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 Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system)
  • No prior systemic treatment for ES-SCLC
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Measurable disease, as defined by 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:

  • Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation
  • Malignancies other than 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
  • Pregnant or lactating women
  • History of autoimmune disease
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Positive test result for human immunodeficiency virus (HIV)
  • Active hepatitis B or hepatitis C
  • Severe infections at the time of randomization
  • Significant cardiovascular disease
  • Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (PD-1), and anti-PD-L1 therapeutic antibody
  • History of severe (or known) hypersensitivity to chimeric or humanized antibodies or fusion proteins or any component of atezolizumab formulation.

Sites / Locations

  • Florida Cancer Specialists - Fort Myers (Broadway)
  • Florida Hospital
  • Florida Cancer Specialists.
  • Northwest Georgia Oncology Centers PC - Marietta
  • Rush University Medical Center
  • Illinois Cancer Care
  • Cancer Treatment Centers of America - Midwestern Regional Medical Center
  • Louisville Oncology
  • New England Cancer Specialists
  • Weinberg CA Inst Franklin Sq
  • Mayo Clinic
  • Comprehensive Cancer Centers of Nevada - Eastern Avenue
  • The Valley Hospital
  • Broome Oncology - Binghamton
  • Levine Cancer Institute
  • Tennessee Oncology Chattanooga
  • Tennessee Oncology PLLC - Nashville (20th Ave)
  • Vanderbilt Medical Center
  • Virginia Cancer Specialists, PC
  • Blue Ridge Cancer Care
  • Northwest Medical Specialties
  • University of Wisconsin
  • Chris O'Brien Lifehouse
  • The Prince Charles Hospital; Oncology Dept.
  • Royal Melbourne Hospital; Hematology and Medical Oncology
  • Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Lungenkrankheiten
  • Salzburger Landeskliniken; Universitätsklinik für Pneumologie/ Lungenheilkunde
  • Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten
  • Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie
  • Santa Casa de Misericordia de Salvador
  • Hospital Bruno Born
  • Hospital das Clinicas - UFRGS
  • Instituto do Cancer do Estado de Sao Paulo - ICESP
  • Bradford Hill Centro de Investigaciones Clinicas
  • OrlandiOncología
  • Beijing Cancer Hospital
  • Jilin Cancer Hospital
  • The First Affiliated Hospital of Guangzhou Medical University
  • Harbin Medical University Cancer Hospital
  • Jiangsu Cancer Hospital
  • Fudan University Shanghai Cancer Center
  • Zhongshan Hospital Fudan University
  • Zhejiang Cancer Hospital
  • Henan Cancer Hospital
  • Fakultni nemocnice Olomouc
  • Thomayerova nemocnice
  • Fakultni nemocnice Na Bulovce
  • Institut Bergonie; Oncologie
  • Centre Francois Baclesse; Oncologie
  • Hopital Calmette; Pneumologie Oncologie Ouest
  • Hôpital Nord - AP-HM Marseille#
  • Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie
  • LungenClinic Großhansdorf GmbH
  • Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
  • Thoraxklinik Heidelberg gGmbH
  • Fachklinik für Lungenerkrankungen
  • Sotiria Chest Hospital of Athens
  • Agioi Anargyroi; 3Rd Dept. of Medical Oncology
  • University Hospital of Patras Medical Oncology
  • Semmelweis Egyetem, AOK, Pulmonologiai Klinika
  • Orszagos Koranyi TBC es Pulmonologiai Intezet
  • Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika
  • Tudogyogyintezet Torokbalint
  • A.O. Universitaria Di Parma
  • Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia
  • IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
  • Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare
  • Kyushu University Hospital; Respiratory
  • National Hospital Organization Himeji Medical Center
  • Kanagawa Cancer Center;Thoracic Oncology
  • University Hospital Kyoto Prefectural University of Medicine,?Pulmonary Medicine
  • Sendai Kousei Hospital; Pulmonary Medicine
  • Kurashiki Central Hospital; Respiratory Medicine
  • Kindai University Hospital; Medical Oncology
  • National Hospital Organization Kinki-Chuo Chest Medical Center; Internal Medicine
  • Saitama Cancer Center; Thoracic Oncology
  • Shizuoka Cancer Center; Thoracic Oncology
  • Tokyo Metropolitan Komagome Hospital; Thoracic Oncology and Respiratory Medicine
  • The Cancer Institute Hospital of JFCR, Respiratory Medicine
  • Wakayama Medical University Hospital; Respiratory Medicine and Medical Oncology
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Health Pharma Professional Research
  • Medical University of Gdansk
  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
  • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc; Oddzial V Chemioterapii Nowotworow Pluc
  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
  • Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology
  • Moscow City Oncology Hospital #62
  • N.N.Burdenko Main Military Clinical Hospital; Oncology Dept
  • Russian Oncology Research Center n.a. N.N. Blokhin
  • City Clinical Onc.
  • Scientific Research Oncology Institute named after N.N. Petrov; Oncology
  • City Clinical Hospital No. 1
  • Clinical Center of Serbia
  • Clinical Center Nis; Clinic for pulmonary diseases
  • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Hospital Ramon y Cajal; 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
  • Hosp Clinico Univ Lozano Blesa; División De Oncología Médica
  • National Taiwan Uni Hospital; Internal Medicine
  • Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
  • Chang Gung Medical Foundation - Linkou; Chest Dept
  • Royal Devon & Exeter Hospital; Oncology Centre
  • Barts and the London NHS Trust.
  • Guys and St Thomas NHS Foundation Trust, Guys Hospital
  • Christie Hospital Nhs Trust; Medical Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Atezolizumab + Carboplatin + Etoposide

Placebo + Carboplatin + Etoposide

Arm Description

Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.

Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.

Outcomes

Primary Outcome Measures

Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least 20% increase in the sum of the longest diameter of target lesions compared to baseline, or unequivocal progression in non-target lesion(s), or the appearance of new lesion(s).
Duration of Overall Survival (OS) in the Global Population
OS is defined as the time from randomization to death from any cause.

Secondary Outcome Measures

Percentage of Participants With Objective Response Rate (ORR) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
Objective response (OR) is defined as complete response (CR) or partial response (PR) as determined by the investigator according to RECIST v1.1.
Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
DOR is defined as the time interval from first occurrence of a documented objective response to the time of disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever comes first.
PFS Rate at 6 Months and at 1 Year in Global Population
PFS rates at 6 months and at 1 year is defined as the proportion of participants who are alive without disease progression 6 months and 1 year after randomization, respectively.
OS Rate at 1 Year and 2 Years in the Global Population
OS rates at 1 and 2 years is defined as the proportion of participants who are alive 1 year and 2 years after randomization, respectively.
Time to Deterioration (TTD) Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30) and Supplemental Lung Cancer Module (QLQ-LC13) in the Global Population
TTD according to the EORTC QLQ-C30 and EORTC QLQ-LC13 measures were evaluated in each of the following linearly transformed symptom scores: cough, dyspnea (single item), dyspnea (multi-item subscale), chest pain, or arm/shoulder pain. The linear transformation gives each individual symptom subscale a possible score of 0 to 100. For the symptom to be considered "deteriorated," a score increase of ≥10 points above baseline must be held for at least two consecutive assessments or an initial score increase of ≥10 points is followed by death within 3 weeks from the last assessment. A ≥ 10-point change in the symptoms subscale score is perceived by participants as clinically significant.
Percentage of Participants With at Least One Adverse Event in the Global Population
The percentage of participants with at least one adverse event in the global population.
Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab in the Global Population
The baseline prevalence and post-baseline incidence of ADAs against atezolizumab.
Maximum Observed Serum Concentration (Cmax) of Atezolizumab in the Global Population
Atezolizumab maximum observed plasma concentration (Cmax; 30 minutes following the end of the atezolizumab infusion) for each respective day.
Minimum Observed Serum Concentration (Cmin) of Atezolizumab in the Global Population
Atezolizumab pre-dose plasma concentration (Cmin) for each respective day.
Plasma Concentration of Carboplatin in the Global Population
Plasma concentration of carboplatin in the Global population.
Plasma Concentration of Etoposide in the Global Population
Plasma concentration of etoposide in the Global Population.

Full Information

First Posted
May 4, 2016
Last Updated
July 10, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02763579
Brief Title
A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)
Acronym
IMpower133
Official Title
A Phase I/III, Randomized, Double-Blind, Placebo-Controlled Study of Carboplatin Plus Etoposide With or Without Atezolizumab (Anti-PD-L1 Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 7, 2016 (Actual)
Primary Completion Date
April 24, 2018 (Actual)
Study Completion Date
July 7, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study was designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC. Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin + etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the induction phase followed by maintenance with atezolizumab or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
503 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atezolizumab + Carboplatin + Etoposide
Arm Type
Experimental
Arm Description
Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
Arm Title
Placebo + Carboplatin + Etoposide
Arm Type
Active Comparator
Arm Description
Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Other Intervention Name(s)
MPDL3280A, RO5541267, Tecentriq
Intervention Description
Atezolizumab intravenous infusion was administered at a dose of 1200 mg on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4) and maintenance phase (Cycle 5 onward).
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
Etoposide intravenous infusion was administered at a dose of 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle during the induction phase (Cycles 1-4).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo intravenous infusion was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4) and maintenance phase (Cycle 5 onward).
Primary Outcome Measure Information:
Title
Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
Description
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least 20% increase in the sum of the longest diameter of target lesions compared to baseline, or unequivocal progression in non-target lesion(s), or the appearance of new lesion(s).
Time Frame
Baseline until PD or death, whichever occurs first (up to approximately 23 months)
Title
Duration of Overall Survival (OS) in the Global Population
Description
OS is defined as the time from randomization to death from any cause.
Time Frame
Baseline until death from any cause (up to approximately 23 months)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Objective Response Rate (ORR) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
Description
Objective response (OR) is defined as complete response (CR) or partial response (PR) as determined by the investigator according to RECIST v1.1.
Time Frame
Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to approximately 23 months)
Title
Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
Description
DOR is defined as the time interval from first occurrence of a documented objective response to the time of disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever comes first.
Time Frame
First occurrence of PR or CR until PD or death, whichever occurs first (up to approximately 23 months)
Title
PFS Rate at 6 Months and at 1 Year in Global Population
Description
PFS rates at 6 months and at 1 year is defined as the proportion of participants who are alive without disease progression 6 months and 1 year after randomization, respectively.
Time Frame
6 months, 1 year
Title
OS Rate at 1 Year and 2 Years in the Global Population
Description
OS rates at 1 and 2 years is defined as the proportion of participants who are alive 1 year and 2 years after randomization, respectively.
Time Frame
1 year, 2 years
Title
Time to Deterioration (TTD) Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30) and Supplemental Lung Cancer Module (QLQ-LC13) in the Global Population
Description
TTD according to the EORTC QLQ-C30 and EORTC QLQ-LC13 measures were evaluated in each of the following linearly transformed symptom scores: cough, dyspnea (single item), dyspnea (multi-item subscale), chest pain, or arm/shoulder pain. The linear transformation gives each individual symptom subscale a possible score of 0 to 100. For the symptom to be considered "deteriorated," a score increase of ≥10 points above baseline must be held for at least two consecutive assessments or an initial score increase of ≥10 points is followed by death within 3 weeks from the last assessment. A ≥ 10-point change in the symptoms subscale score is perceived by participants as clinically significant.
Time Frame
Baseline until deterioration per symptom subscale (up to approximately 23 months)
Title
Percentage of Participants With at Least One Adverse Event in the Global Population
Description
The percentage of participants with at least one adverse event in the global population.
Time Frame
Baseline until up to 90 days after end of treatment (up to approximately 49 months)
Title
Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab in the Global Population
Description
The baseline prevalence and post-baseline incidence of ADAs against atezolizumab.
Time Frame
Predose (0 hours [H]) on Day (D) 1 of Cycles (C) 1, 2, 3, 4, 8, 16, and every 8 cycles (Q8C) thereafter (cycle = 21 days) until treatment discontinuation (up to 23 months) and 120 days after last dose (up to approximately 23 months overall)
Title
Maximum Observed Serum Concentration (Cmax) of Atezolizumab in the Global Population
Description
Atezolizumab maximum observed plasma concentration (Cmax; 30 minutes following the end of the atezolizumab infusion) for each respective day.
Time Frame
Post-dose Day 1 of Cycle 1 (cycle length = 21 days)
Title
Minimum Observed Serum Concentration (Cmin) of Atezolizumab in the Global Population
Description
Atezolizumab pre-dose plasma concentration (Cmin) for each respective day.
Time Frame
Predose on Day 1 of Cycles 1, 3, 4, 8, 16 and 24 (cycle length = 21 days)
Title
Plasma Concentration of Carboplatin in the Global Population
Description
Plasma concentration of carboplatin in the Global population.
Time Frame
Predose, before end of infusion, and after end of carboplatin infusion on Day 1 of Cycle 1 and Cycle 3 (cycle = 21 days)
Title
Plasma Concentration of Etoposide in the Global Population
Description
Plasma concentration of etoposide in the Global Population.
Time Frame
Predose, before end of infusion, 1 and 4 hours after end of carboplatin infusion on Day 1 of Cycle 1 and Cycle 3 (cycle = 21 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system) No prior systemic treatment for ES-SCLC Eastern Cooperative Oncology Group performance status of 0 or 1 Measurable disease, as defined by 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: Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation Malignancies other than 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 Pregnant or lactating women History of autoimmune disease History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted. Positive test result for human immunodeficiency virus (HIV) Active hepatitis B or hepatitis C Severe infections at the time of randomization Significant cardiovascular disease Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (PD-1), and anti-PD-L1 therapeutic antibody History of severe (or known) hypersensitivity to chimeric or humanized antibodies or fusion proteins or any component of atezolizumab formulation.
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
Florida Cancer Specialists - Fort Myers (Broadway)
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Florida Cancer Specialists.
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
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3244
Country
United States
Facility Name
Illinois Cancer Care
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Cancer Treatment Centers of America - Midwestern Regional Medical Center
City
Zion
State/Province
Illinois
ZIP/Postal Code
60099
Country
United States
Facility Name
Louisville Oncology
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
New England Cancer Specialists
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Weinberg CA Inst Franklin Sq
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada - Eastern Avenue
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
The Valley Hospital
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
Broome Oncology - Binghamton
City
Binghamton
State/Province
New York
ZIP/Postal Code
13905
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Tennessee Oncology Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Tennessee Oncology PLLC - Nashville (20th Ave)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-7610
Country
United States
Facility Name
Virginia Cancer Specialists, PC
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
Northwest Medical Specialties
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
The Prince Charles Hospital; Oncology Dept.
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Royal Melbourne Hospital; Hematology and Medical Oncology
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Lungenkrankheiten
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Salzburger Landeskliniken; Universitätsklinik für Pneumologie/ Lungenheilkunde
City
Salzburg
ZIP/Postal Code
5020
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
Santa Casa de Misericordia de Salvador
City
Salvador
State/Province
BA
ZIP/Postal Code
40050-410
Country
Brazil
Facility Name
Hospital Bruno Born
City
Lajeado
State/Province
RS
ZIP/Postal Code
95900-000
Country
Brazil
Facility Name
Hospital das Clinicas - UFRGS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
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
Bradford Hill Centro de Investigaciones Clinicas
City
Recoleta
ZIP/Postal Code
8420383
Country
Chile
Facility Name
OrlandiOncología
City
Santiago
ZIP/Postal Code
7500713
Country
Chile
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
ZIP/Postal Code
132013
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing City
ZIP/Postal Code
211100
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai City
ZIP/Postal Code
200120
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Thomayerova nemocnice
City
Praha 4 - Krc
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Fakultni nemocnice Na Bulovce
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Institut Bergonie; Oncologie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Francois Baclesse; Oncologie
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Hopital Calmette; Pneumologie Oncologie Ouest
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Nord - AP-HM Marseille#
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
LungenClinic Großhansdorf GmbH
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Thoraxklinik Heidelberg gGmbH
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Fachklinik für Lungenerkrankungen
City
Immenhausen
ZIP/Postal Code
34376
Country
Germany
Facility Name
Sotiria Chest Hospital of Athens
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Agioi Anargyroi; 3Rd Dept. of Medical Oncology
City
Athens
ZIP/Postal Code
145 64
Country
Greece
Facility Name
University Hospital of Patras Medical Oncology
City
Patras
ZIP/Postal Code
265 04
Country
Greece
Facility Name
Semmelweis Egyetem, AOK, Pulmonologiai Klinika
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Orszagos Koranyi TBC es Pulmonologiai Intezet
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Tudogyogyintezet Torokbalint
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
A.O. Universitaria Di Parma
City
Parma
State/Province
Emilia-Romagna
ZIP/Postal Code
43100
Country
Italy
Facility Name
Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
City
Roma
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
City
San Giovanni Rotondo
State/Province
Puglia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56124
Country
Italy
Facility Name
Kyushu University Hospital; Respiratory
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
National Hospital Organization Himeji Medical Center
City
Hyogo
ZIP/Postal Code
670-8520
Country
Japan
Facility Name
Kanagawa Cancer Center;Thoracic Oncology
City
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
University Hospital Kyoto Prefectural University of Medicine,?Pulmonary Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Sendai Kousei Hospital; Pulmonary Medicine
City
Miyagi
ZIP/Postal Code
980-0873
Country
Japan
Facility Name
Kurashiki Central Hospital; Respiratory Medicine
City
Okayama
ZIP/Postal Code
710-8602
Country
Japan
Facility Name
Kindai University Hospital; Medical Oncology
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
National Hospital Organization Kinki-Chuo Chest Medical Center; Internal Medicine
City
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Saitama Cancer Center; Thoracic Oncology
City
Satima
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Shizuoka Cancer Center; Thoracic Oncology
City
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Tokyo Metropolitan Komagome Hospital; Thoracic Oncology and Respiratory Medicine
City
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR, Respiratory Medicine
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Wakayama Medical University Hospital; Respiratory Medicine and Medical Oncology
City
Wakayama
ZIP/Postal Code
641-8509
Country
Japan
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
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Health Pharma Professional Research
City
Cdmx
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Medical University of Gdansk
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc; Oddzial V Chemioterapii Nowotworow Pluc
City
Olsztyn
ZIP/Postal Code
10-357
Country
Poland
Facility Name
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
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
Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Moscow City Oncology Hospital #62
City
Moscovskaya Oblast
State/Province
Moskovskaja Oblast
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
N.N.Burdenko Main Military Clinical Hospital; Oncology Dept
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Russian Oncology Research Center n.a. N.N. Blokhin
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
City Clinical Onc.
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Scientific Research Oncology Institute named after N.N. Petrov; Oncology
City
St. Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
City Clinical Hospital No. 1
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Nis; Clinic for pulmonary diseases
City
Nis
ZIP/Postal Code
18 000
Country
Serbia
Facility Name
Hospital Univ Vall d'Hebron; Servicio de Oncologia
City
Sant Andreu de La Barca
State/Province
Barcelona
ZIP/Postal Code
08740
Country
Spain
Facility Name
Hospital Ramon y Cajal; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28034
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
Hosp Clinico Univ Lozano Blesa; División De Oncología Médica
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
National Taiwan Uni Hospital; Internal Medicine
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Chang Gung Medical Foundation - Linkou; Chest Dept
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Royal Devon & Exeter Hospital; Oncology Centre
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Barts and the London NHS Trust.
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Guys and St Thomas NHS Foundation Trust, Guys Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Christie Hospital Nhs Trust; Medical Oncology
City
Manchester
ZIP/Postal Code
M2O 4BX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33439693
Citation
Liu SV, Reck M, Mansfield AS, Mok T, Scherpereel A, Reinmuth N, Garassino MC, De Castro Carpeno J, Califano R, Nishio M, Orlandi F, Alatorre-Alexander J, Leal T, Cheng Y, Lee JS, Lam S, McCleland M, Deng Y, Phan S, Horn L. Updated Overall Survival and PD-L1 Subgroup Analysis of Patients With Extensive-Stage Small-Cell Lung Cancer Treated With Atezolizumab, Carboplatin, and Etoposide (IMpower133). J Clin Oncol. 2021 Feb 20;39(6):619-630. doi: 10.1200/JCO.20.01055. Epub 2021 Jan 13.
Results Reference
derived
PubMed Identifier
31959349
Citation
Mansfield AS, Kazarnowicz A, Karaseva N, Sanchez A, De Boer R, Andric Z, Reck M, Atagi S, Lee JS, Garassino M, Liu SV, Horn L, Wen X, Quach C, Yu W, Kabbinavar F, Lam S, Morris S, Califano R. Safety and patient-reported outcomes of atezolizumab, carboplatin, and etoposide in extensive-stage small-cell lung cancer (IMpower133): a randomized phase I/III trial. Ann Oncol. 2020 Feb;31(2):310-317. doi: 10.1016/j.annonc.2019.10.021. Epub 2019 Dec 9.
Results Reference
derived
PubMed Identifier
31466854
Citation
Nishio M, Sugawara S, Atagi S, Akamatsu H, Sakai H, Okamoto I, Takayama K, Hayashi H, Nakagawa Y, Kawakami T. Subgroup Analysis of Japanese Patients in a Phase III Study of Atezolizumab in Extensive-stage Small-cell Lung Cancer (IMpower133). Clin Lung Cancer. 2019 Nov;20(6):469-476.e1. doi: 10.1016/j.cllc.2019.07.005. Epub 2019 Jul 31.
Results Reference
derived
PubMed Identifier
30280641
Citation
Horn L, Mansfield AS, Szczesna A, Havel L, Krzakowski M, Hochmair MJ, Huemer F, Losonczy G, Johnson ML, Nishio M, Reck M, Mok T, Lam S, Shames DS, Liu J, Ding B, Lopez-Chavez A, Kabbinavar F, Lin W, Sandler A, Liu SV; IMpower133 Study Group. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018 Dec 6;379(23):2220-2229. doi: 10.1056/NEJMoa1809064. Epub 2018 Sep 25.
Results Reference
derived

Learn more about this trial

A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)

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