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AzTrials

Small Cell Lung CarcinomaPhase 3IMpower133NCT02763579

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

A Phase 3 study testing Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Carboplatin and Etoposide in people with Small Cell Lung Carcinoma, run by Hoffmann-La Roche at 114 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Carcinoma
What is being tested?
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Carboplatin and Etoposide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
503 participants
Where
114 sitesin 21 countries
Study dates
7 Jun 2016to 7 Jul 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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.

Trial locations and contacts

114 sites in 21 countries.

114 sites in 21 countries

United States22 sites

  • Weinberg CA Inst Franklin Sq

    Baltimore, Maryland, 21237

  • Broome Oncology - Binghamton

    Binghamton, New York, 13905

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Tennessee Oncology Chattanooga

    Chattanooga, Tennessee, 37404

  • Rush University Medical Center

    Chicago, Illinois, 60612-3244

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Florida Cancer Specialists - Fort Myers (Broadway)

    Fort Myers, Florida, 33901

  • Comprehensive Cancer Centers of Nevada - Eastern Avenue

    Las Vegas, Nevada, 89169

  • Louisville Oncology

    Louisville, Kentucky, 40202

  • University of Wisconsin

    Madison, Wisconsin, 53705

  • Northwest Georgia Oncology Centers PC - Marietta

    Marietta, Georgia, 30060

  • Tennessee Oncology PLLC - Nashville (20th Ave)

    Nashville, Tennessee, 37203

  • Vanderbilt Medical Center

    Nashville, Tennessee, 37232-7610

  • Florida Hospital

    Orlando, Florida, 32804

  • The Valley Hospital

    Paramus, New Jersey, 07652

  • Illinois Cancer Care

    Peoria, Illinois, 61615

  • Blue Ridge Cancer Care

    Roanoke, Virginia, 24014

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • New England Cancer Specialists

    Scarborough, Maine, 04074

  • Florida Cancer Specialists.

    St. Petersburg, Florida, 33705

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • Cancer Treatment Centers of America - Midwestern Regional Medical Center

    Zion, Illinois, 60099

Other trials in United States

Japan13 sites

  • Kyushu University Hospital; Respiratory

    Fukuoka, 812-8582

  • National Hospital Organization Himeji Medical Center

    Hyōgo, 670-8520

  • Kanagawa Cancer Center;Thoracic Oncology

    Kanagawa, 241-8515

  • University Hospital Kyoto Prefectural University of Medicine,?Pulmonary Medicine

    Kyoto, 602-8566

  • Sendai Kousei Hospital; Pulmonary Medicine

    Miyagi, 980-0873

  • Kurashiki Central Hospital; Respiratory Medicine

    Okayama, 710-8602

  • Kindai University Hospital; Medical Oncology

    Osaka, 589-8511

  • National Hospital Organization Kinki-Chuo Chest Medical Center; Internal Medicine

    Osaka, 591-8555

  • Saitama Cancer Center; Thoracic Oncology

    Satima, 362-0806

  • Shizuoka Cancer Center; Thoracic Oncology

    Shizuoka, 411-8777

  • Tokyo Metropolitan Komagome Hospital; Thoracic Oncology and Respiratory Medicine

    Tokyo, 113-8677

  • The Cancer Institute Hospital of JFCR, Respiratory Medicine

    Tokyo, 135-8550

  • Wakayama Medical University Hospital; Respiratory Medicine and Medical Oncology

    Wakayama, 641-8509

Other trials in Japan

China9 sites

  • Beijing Cancer Hospital

    Beijing, 100142

  • Jilin Cancer Hospital

    Changchun, 132013

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Jiangsu Cancer Hospital

    Nanjing, 211100

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120

  • Zhejiang Cancer Hospital

    Zhejiang, 310022

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Italy6 sites

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Lombardy, 20133

  • Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia

    Milan, Lombardy, 20141

  • A.O. Universitaria Di Parma

    Parma, Emilia-Romagna, 43100

  • Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare

    Pisa, Tuscany, 56124

  • Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

    Rome, Lazio, 00128

  • IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

    San Giovanni Rotondo, Apulia, 71013

Other trials in Italy

Poland6 sites

  • Medical University of Gdansk

    Gdansk, 80-952

  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

    Lodz, 93-513

  • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc; Oddzial V Chemioterapii Nowotworow Pluc

    Olsztyn, 10-357

  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

    Otwock, 05-400

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

    Poznan, 60-569

  • Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology

    Warsaw, 02-781

Other trials in Poland

Russia6 sites

  • Moscow City Oncology Hospital #62

    Moscovskaya Oblast, Moscow Oblast, 143423

  • N.N.Burdenko Main Military Clinical Hospital; Oncology Dept

    Moscow, Moscow Oblast, 105229

  • Russian Oncology Research Center n.a. N.N. Blokhin

    Moscow, Moscow Oblast, 115478

  • City Clinical Hospital No. 1

    Novosibirsk, 630047

  • Scientific Research Oncology Institute named after N.N. Petrov; Oncology

    Saint Petersburg, Sankt-Peterburg, 197758

  • City Clinical Onc.

    Saint Petersburg, Sankt-Peterburg, 198255

Other trials in Russia

Spain6 sites

  • Hospital Ramon y Cajal; Servicio de Oncologia

    Madrid, 28034

  • Hospital Universitario La Paz; Servicio de Oncologia

    Madrid, 28046

  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

    Málaga, 29010

  • Hospital Univ Vall d'Hebron; Servicio de Oncologia

    Sant Andreu de la Barca, Barcelona, 08740

  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia

    Seville, 41013

  • Hosp Clinico Univ Lozano Blesa; División De Oncología Médica

    Zaragoza, 50009

Other trials in Spain

Germany5 sites

  • Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie

    Gauting, 82131

  • LungenClinic Großhansdorf GmbH

    Großhansdorf, 22927

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II

    Halle, 06120

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, 69126

  • Fachklinik für Lungenerkrankungen

    Immenhausen, 34376

Other trials in Germany

Austria4 sites

  • Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Lungenkrankheiten

    Linz, 4020

  • Salzburger Landeskliniken; Universitätsklinik für Pneumologie/ Lungenheilkunde

    Salzburg, 5020

  • Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten

    Vienna, 1140

  • Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie

    Vienna, 1210

Other trials in Austria

Brazil4 sites

  • Hospital Bruno Born

    Lajeado, Rio Grande do Sul, 95900-000

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Santa Casa de Misericordia de Salvador

    Salvador, Estado de Bahia, 40050-410

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000

Other trials in Brazil

France4 sites

  • Institut Bergonie; Oncologie

    Bordeaux, 33076

  • Centre Francois Baclesse; Oncologie

    Caen, 14076

  • Hopital Calmette; Pneumologie Oncologie Ouest

    Lille, 59037

  • Hôpital Nord - AP-HM Marseille#

    Marseille, 13915

Other trials in France

Hungary4 sites

  • Semmelweis Egyetem, AOK, Pulmonologiai Klinika

    Budapest, 1083

  • Orszagos Koranyi TBC es Pulmonologiai Intezet

    Budapest, 1121

  • Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika

    Debrecen, 4032

  • Tudogyogyintezet Torokbalint

    Törökbálint, 2045

Other trials in Hungary

South Korea4 sites

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 135-710

Other trials in South Korea

United Kingdom4 sites

  • Royal Devon & Exeter Hospital; Oncology Centre

    Exeter, EX2 5DW

  • Barts and the London NHS Trust.

    London, EC1A 7BE

  • Guys and St Thomas NHS Foundation Trust, Guys Hospital

    London, SE1 9RT

  • Christie Hospital Nhs Trust; Medical Oncology

    Manchester, M2O 4BX

Other trials in United Kingdom

Australia3 sites

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • The Prince Charles Hospital; Oncology Dept.

    Chermside, Queensland, 4032

  • Royal Melbourne Hospital; Hematology and Medical Oncology

    Parkville, Victoria, 3052

Other trials in Australia

Czechia3 sites

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

  • Fakultni nemocnice Na Bulovce

    Prague, 180 81

  • Thomayerova nemocnice

    Praha 4 - Krc, 140 59

Other trials in Czechia

Greece3 sites

  • Sotiria Chest Hospital of Athens

    Athens, 11527

  • Agioi Anargyroi; 3Rd Dept. of Medical Oncology

    Athens, 145 64

  • University Hospital of Patras Medical Oncology

    Pátrai, 265 04

Other trials in Greece

Taiwan3 sites

  • National Taiwan Uni Hospital; Internal Medicine

    Taipei, 100

  • Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology

    Taipei, 112

  • Chang Gung Medical Foundation - Linkou; Chest Dept

    Taoyuan, 333

Other trials in Taiwan

Chile2 sites

  • Bradford Hill Centro de Investigaciones Clinicas

    Recoleta, 8420383

  • OrlandiOncología

    Santiago, 7500713

Other trials in Chile

Serbia2 sites

  • Clinical Center of Serbia

    Belgrade, 11000

  • Clinical Center Nis; Clinic for pulmonary diseases

    Niš, 18 000

Other trials in Serbia

Mexico1 site

  • Health Pharma Professional Research

    Mexico City, Mexico CITY (federal District), 03100

Other trials in Mexico

About this study

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

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.

Being tested
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Carboplatin, Etoposide, Placebo
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibodyDrug

    Also called MPDL3280A, RO5541267, Tecentriq

    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).

  • CarboplatinDrug

    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).

  • EtoposideDrug

    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).

  • PlaceboDrug

    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).

Study groups in NCT02763579
Study groupRoleWhat they receive
Atezolizumab + Carboplatin + EtoposideExperimentalParticipants 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.
Receives: Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody; Drug: Carboplatin; Drug: Etoposide
Placebo + Carboplatin + EtoposideActive comparatorParticipants 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.
Receives: Drug: Carboplatin; Drug: Etoposide; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline until PD or death, whichever occurs first (up to approximately 23 months)

  2. Duration of Overall Survival (OS) in the Global Population

    OS is defined as the time from randomization to death from any cause.

    Measured: Baseline until death from any cause (up to approximately 23 months)

Secondary outcomes (11)

  1. 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.

    Measured: Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to approximately 23 months)

  2. 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.

    Measured: First occurrence of PR or CR until PD or death, whichever occurs first (up to approximately 23 months)

  3. 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.

    Measured: 6 months, 1 year

  4. 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.

    Measured: 1 year, 2 years

  5. 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.

    Measured: Baseline until deterioration per symptom subscale (up to approximately 23 months)

  6. 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.

    Measured: Baseline until up to 90 days after end of treatment (up to approximately 49 months)

  7. 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.

    Measured: 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)

  8. 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.

    Measured: Post-dose Day 1 of Cycle 1 (cycle length = 21 days)

  9. Minimum Observed Serum Concentration (Cmin) of Atezolizumab in the Global Population

    Atezolizumab pre-dose plasma concentration (Cmin) for each respective day.

    Measured: Predose on Day 1 of Cycles 1, 3, 4, 8, 16 and 24 (cycle length = 21 days)

  10. Plasma Concentration of Carboplatin in the Global Population

    Plasma concentration of carboplatin in the Global population.

    Measured: Predose, before end of infusion, and after end of carboplatin infusion on Day 1 of Cycle 1 and Cycle 3 (cycle = 21 days)

  11. Plasma Concentration of Etoposide in the Global Population

    Plasma concentration of etoposide in the Global Population.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2016 (estimated)
  2. Study start7 Jun 2016
  3. Primary completion24 Apr 2018
  4. Study completion7 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
503 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02763579
Sponsor's protocol ID
GO30081
Other IDs
2015-004861-97, 2015
Acronym
IMpower133
Status last verified
Jul 2023
First submitted
4 May 2016
Last updated
28 Jul 2023

Publications

  • Bernabe R, Liu SV, Sanchez-Gastaldo A, Alonso Garcia M. Long-Term Survival and Stable Disease in a Patient with Extensive-Stage Small-Cell Lung Cancer after Treatment with Carboplatin, Etoposide and Atezolizumab. Oncol Ther. 2024 Mar;12(1):175-182. doi: 10.1007/s40487-023-00257-0. Epub 2024 Jan 27.

    PubMed 38280181

  • Liu SV, Mok TSK, Nabet BY, Mansfield AS, De Boer R, Losonczy G, Sugawara S, Dziadziuszko R, Krzakowski M, Smolin A, Hochmair MJ, Garassino MC, Gay CM, Heymach JV, Byers LA, Lam S, Cardona A, Morris S, Adler L, Shames DS, Reck M. Clinical and molecular characterization of long-term survivors with extensive-stage small cell lung cancer treated with first-line atezolizumab plus carboplatin and etoposide. Lung Cancer. 2023 Dec;186:107418. doi: 10.1016/j.lungcan.2023.107418. Epub 2023 Oct 31.

    PubMed 37931445

  • 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.

    PubMed 33439693

  • 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.

    PubMed 31959349

  • 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.

    PubMed 31466854

  • 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.

    PubMed 30280641

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Carboplatin and Etoposide in people with Small Cell Lung Carcinoma, run by Hoffmann-La Roche at 114 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in United States, Japan, China, Italy, Poland and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 in the Global Population (time frame: Baseline until PD or death, whichever occurs first (up to approximately 23 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02763579, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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