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

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

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.

Study Overview

• Status: Completed
• Conditions: Small Cell Lung Carcinoma
• Intervention / Treatment: Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody; Drug: Carboplatin; Drug: Etoposide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 503
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Chris O'Brien Lifehouse
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • The Prince Charles Hospital; Oncology Dept.
  • Victoria
    • Parkville, Victoria, Australia, 3052
      • Royal Melbourne Hospital; Hematology and Medical Oncology
• Austria
  • Linz, Austria, 4020
    • Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Lungenkrankheiten
  • Salzburg, Austria, 5020
    • Salzburger Landeskliniken; Universitätsklinik für Pneumologie/ Lungenheilkunde
  • Wien, Austria, 1210
    • Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie
  • Wien, Austria, 1140
    • Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten
• Brazil
  • BA
    • Salvador, BA, Brazil, 40050-410
      • Santa Casa de Misericordia de Salvador
  • RS
    • Lajeado, RS, Brazil, 95900-000
      • Hospital Bruno Born
    • Porto Alegre, RS, Brazil, 90035-903
      • Hospital das Clinicas - UFRGS
  • SP
    • Sao Paulo, SP, Brazil, 01246-000
      • Instituto do Cancer do Estado de Sao Paulo - ICESP
• Chile
  • Recoleta, Chile, 8420383
    • Bradford Hill Centro de Investigaciones Clinicas
  • Santiago, Chile, 7500713
    • OrlandiOncología
• China
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Changchun, China, 132013
    • Jilin Cancer Hospital
  • Guangzhou, China, 510120
    • The First Affiliated Hospital of Guangzhou Medical University
  • Harbin, China, 150081
    • Harbin Medical University Cancer Hospital
  • Nanjing City, China, 211100
    • Jiangsu Cancer Hospital
  • Shanghai, China, 200032
    • Zhongshan Hospital Fudan University
  • Shanghai City, China, 200120
    • Fudan University Shanghai Cancer Center
  • Zhejiang, China, 310022
    • Zhejiang Cancer Hospital
  • Zhengzhou, China, 450008
    • Henan cancer hospital
• Czechia
  • Olomouc, Czechia, 779 00
    • Fakultní Nemocnice Olomouc
  • Praha 4 - Krc, Czechia, 140 59
    • Thomayerova nemocnice
  • Praha 8, Czechia, 180 81
    • Fakultni nemocnice Na Bulovce
• France
  • Bordeaux, France, 33076
    • Institut Bergonie; Oncologie
  • Caen, France, 14076
    • Centre Francois Baclesse; Oncologie
  • Lille, France, 59037
    • Hopital Calmette; Pneumologie Oncologie Ouest
  • Marseille, France, 13915
    • Hôpital Nord - AP-HM Marseille#
• Germany
  • Gauting, Germany, 82131
    • Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie
  • Großhansdorf, Germany, 22927
    • LungenClinic Grosshansdorf GmbH
  • Halle, Germany, 06120
    • Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
  • Heidelberg, Germany, 69126
    • Thoraxklinik Heidelberg gGmbH
  • Immenhausen, Germany, 34376
    • Fachklinik für Lungenerkrankungen
• Greece
  • Athens, Greece, 11527
    • Sotiria Chest Hospital of Athens
  • Athens, Greece, 145 64
    • Agioi Anargyroi; 3Rd Dept. of Medical Oncology
  • Patras, Greece, 265 04
    • University Hospital of Patras Medical Oncology
• Hungary
  • Budapest, Hungary, 1121
    • Orszagos Koranyi TBC es Pulmonologiai Intezet
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem, AOK, Pulmonologiai Klinika
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika
  • Torokbalint, Hungary, 2045
    • Tudogyogyintezet Torokbalint
• Italy
  • Emilia-Romagna
    • Parma, Emilia-Romagna, Italy, 43100
      • A.O. Universitaria Di Parma
  • Lazio
    • Roma, Lazio, Italy, 00128
      • Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
  • Lombardia
    • Milano, Lombardia, Italy, 20133
      • Fondazione Irccs Istituto Nazionale Dei Tumori
    • Milano, Lombardia, Italy, 20141
      • Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia
  • Puglia
    • San Giovanni Rotondo, Puglia, Italy, 71013
      • IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
  • Toscana
    • Pisa, Toscana, Italy, 56124
      • Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare
• Japan
  • Fukuoka, Japan, 812-8582
    • Kyushu University Hospital; Respiratory
  • Hyogo, Japan, 670-8520
    • National Hospital Organization Himeji Medical Center
  • Kanagawa, Japan, 241-8515
    • Kanagawa Cancer Center;Thoracic Oncology
  • Kyoto, Japan, 602-8566
    • University Hospital Kyoto Prefectural University of Medicine,?Pulmonary Medicine
  • Miyagi, Japan, 980-0873
    • Sendai Kousei Hospital; Pulmonary Medicine
  • Okayama, Japan, 710-8602
    • Kurashiki Central Hospital; Respiratory Medicine
  • Osaka, Japan, 589-8511
    • Kindai University Hospital; Medical Oncology
  • Osaka, Japan, 591-8555
    • National Hospital Organization Kinki-Chuo Chest Medical Center; Internal Medicine
  • Satima, Japan, 362-0806
    • Saitama Cancer Center; Thoracic Oncology
  • Shizuoka, Japan, 411-8777
    • Shizuoka Cancer Center; Thoracic Oncology
  • Tokyo, Japan, 113-8677
    • Tokyo Metropolitan Komagome Hospital; Thoracic Oncology and Respiratory Medicine
  • Tokyo, Japan, 135-8550
    • The Cancer Institute Hospital of JFCR, Respiratory Medicine
  • Wakayama, Japan, 641-8509
    • Wakayama Medical University Hospital; Respiratory Medicine and Medical Oncology
• Korea, Republic of
  • Seongnam-si, Korea, Republic of, 463-707
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
• Mexico
  • Mexico CITY (federal District)
    • Cdmx, Mexico CITY (federal District), Mexico, 03100
      • Health Pharma Professional Research
• Poland
  • Gdansk, Poland, 80-952
    • Medical University of Gdansk
  • Lodz, Poland, 93-513
    • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
  • Olsztyn, Poland, 10-357
    • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc; Oddzial V Chemioterapii Nowotworow Pluc
  • Otwock, Poland, 05-400
    • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
  • Poznan, Poland, 60-569
    • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
  • Warszawa, Poland, 02-781
    • Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology
• Russian Federation
  • Novosibirsk, Russian Federation, 630047
    • City Clinical Hospital No. 1
  • Moskovskaja Oblast
    • Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423
      • Moscow City Oncology Hospital #62
    • Moscow, Moskovskaja Oblast, Russian Federation, 105229
      • N.N.Burdenko Main Military Clinical Hospital; Oncology Dept
    • Moscow, Moskovskaja Oblast, Russian Federation, 115478
      • Russian Oncology Research Center n.a. N.N. Blokhin
  • Sankt Petersburg
    • Sankt-peterburg, Sankt Petersburg, Russian Federation, 198255
      • City Clinical Onc.
    • St. Petersburg, Sankt Petersburg, Russian Federation, 197758
      • Scientific Research Oncology Institute named after N.N. Petrov; Oncology
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Center of Serbia
  • Nis, Serbia, 18 000
    • Clinical Center Nis; Clinic for pulmonary diseases
• Spain
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal; Servicio de Oncologia
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz; 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
  • Zaragoza, Spain, 50009
    • Hosp Clinico Univ Lozano Blesa; División De Oncología Médica
  • Barcelona
    • Sant Andreu de La Barca, Barcelona, Spain, 08740
      • Hospital Univ Vall d'Hebron; Servicio de Oncologia
• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan Uni Hospital; Internal Medicine
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
  • Taoyuan, Taiwan, 333
    • Chang Gung Medical Foundation - Linkou; Chest Dept
• United Kingdom
  • Exeter, United Kingdom, EX2 5DW
    • Royal Devon & Exeter Hospital; Oncology Centre
  • London, United Kingdom, EC1A 7BE
    • Barts and the London NHS Trust.
  • London, United Kingdom, SE1 9RT
    • Guys and St Thomas NHS Foundation Trust, Guys Hospital
  • Manchester, United Kingdom, M2O 4BX
    • Christie Hospital Nhs Trust; Medical Oncology
• United States
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialists - Fort Myers (Broadway)
    • Orlando, Florida, United States, 32804
      • Florida Hospital
    • Saint Petersburg, Florida, United States, 33705
      • Florida Cancer Specialists.
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Northwest Georgia Oncology Centers PC - Marietta
  • Illinois
    • Chicago, Illinois, United States, 60612-3244
      • Rush University Medical Center
    • Peoria, Illinois, United States, 61615
      • Illinois Cancer Care
    • Zion, Illinois, United States, 60099
      • Cancer Treatment Centers of America - Midwestern Regional Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Louisville Oncology
  • Maine
    • Scarborough, Maine, United States, 04074
      • New England Cancer Specialists
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Weinberg CA Inst Franklin Sq
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Comprehensive Cancer Centers of Nevada - Eastern Avenue
  • New Jersey
    • Paramus, New Jersey, United States, 07652
      • The Valley Hospital
  • New York
    • Binghamton, New York, United States, 13905
      • Broome Oncology - Binghamton
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Tennessee Oncology Chattanooga
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology PLLC - Nashville (20th Ave)
    • Nashville, Tennessee, United States, 37232-7610
      • Vanderbilt Medical Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists, PC
    • Roanoke, Virginia, United States, 24014
      • Blue Ridge Cancer Care
  • Washington
    • Tacoma, Washington, United States, 98405
      • Northwest Medical Specialties
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Histologically or cytologically confirmed 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atezolizumab + Carboplatin + Etoposide; 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.	Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody; 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).; Other Names: MPDL3280A, RO5541267, Tecentriq; Drug: Carboplatin; 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).; Drug: Etoposide; 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).
Active Comparator: Placebo + Carboplatin + Etoposide; 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.	Drug: Carboplatin; 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).; Drug: Etoposide; 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).; Drug: Placebo; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline until PD or death, whichever occurs first (up to approximately 23 months)
Duration of Overall Survival (OS) in the Global Population	OS is defined as the time from randomization to death from any cause.	Baseline until death from any cause (up to approximately 23 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to approximately 23 months)
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.	First occurrence of PR or CR until PD or death, whichever occurs first (up to approximately 23 months)
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.	6 months, 1 year
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.	1 year, 2 years
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.	Baseline until deterioration per symptom subscale (up to approximately 23 months)
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.	Baseline until up to 90 days after end of treatment (up to approximately 49 months)
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.	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)
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.	Post-dose Day 1 of Cycle 1 (cycle length = 21 days)
Minimum Observed Serum Concentration (Cmin) of Atezolizumab in the Global Population	Atezolizumab pre-dose plasma concentration (Cmin) for each respective day.	Predose on Day 1 of Cycles 1, 3, 4, 8, 16 and 24 (cycle length = 21 days)
Plasma Concentration of Carboplatin in the Global Population	Plasma concentration of carboplatin in the Global population.	Predose, before end of infusion, and after end of carboplatin infusion on Day 1 of Cycle 1 and Cycle 3 (cycle = 21 days)
Plasma Concentration of Etoposide in the Global Population	Plasma concentration of etoposide in the Global Population.	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)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2016
• Primary Completion (Actual): April 24, 2018
• Study Completion (Actual): July 7, 2022

Study Registration Dates

• First Submitted: May 4, 2016
• First Submitted That Met QC Criteria: May 4, 2016
• First Posted (Estimated): May 5, 2016

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Carboplatin; Etoposide; Antibodies; Antibodies, Monoclonal; Atezolizumab
• Other Study ID Numbers: GO30081; 2015-004861-97 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No