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NCT02486718

PHASE3

Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This is a Phase III, global, multicenter, open-label, randomized study to compare the efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A) treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured by disease-free survival (DFS) as assessed by the investigator and overall survival (OS). Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC.

Official title: A Phase III, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Best Supportive Care Following Adjuvant Cisplatin-Based Chemotherapy in Patients With Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1280

Start Date

2015-10-31

Completion Date

2027-08-31

Last Updated

2026-02-05

Healthy Volunteers

Conditions

Non-Small Cell Lung Cancer

Interventions

DRUG

Atezolizumab

Participants will receive atezolizumab (1200 mg IV) Q3W for 16 cycles (cycle length=21 days).

DRUG

Cisplatin

Participants will receive cisplatin 75 milligrams per square meter (mg/m\^2) IV on Day 1 of up to four 21-day cycles.

DRUG

Vinorelbine

Participants will receive vinorelbine 30 mg/m\^2 IV on Days 1 and 8 of each of the four 21-day cycles.

DRUG

Docetaxel

Participants will receive docetaxel 75 mg/m\^2 IV on Day 1 of each of the four 21-day cycles.

DRUG

Gemcitabine

Participants will receive gemcitabine 1250 mg/m\^2 IV on Days 1 and 8 of each of the four 21-day cycles.

DRUG

Pemetrexed

Participants will receive pemetrexed 500 mg/m\^2 IV on Day 1 of each of the four 21-day cycles. Pemetrexed will be administered only in participants with non-squamous cell NSCLC.

Inclusion Criteria: Inclusion Criteria for Enrollment Phase * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Histological or cytological diagnosis of Stage IB (tumors greater than or equal to \[\>/=\] 4 centimeters \[cm\])-IIIA (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC (per the Union Internationale Contre le Cancer staging system (UICC)/American Joint Committee on Cancer staging system (AJCC) staging system, 7th edition; Detterbeck et al. 2009) * Participants must have had complete resection of NSCLC 4-12 weeks (\>/=28 days and less than or equal to \[\</=\] 84 days) prior to enrollment and must be adequately recovered from surgery * If mediastinoscopy was not performed preoperatively, it is required that, at a minimum, mediastinal lymph node systematic sampling will have occurred. Systematic sampling is defined as removal of at least one representative lymph node at specified levels. MLND entails resection of all lymph nodes at those same levels. For a right thoracotomy, sampling or MLND is required at levels 4 and 7 and for a left thoracotomy, levels 5 and/or 6 and 7. Exceptions will be granted if there is clear documentation in the operative report or in a separately submitted addendum by the surgeon of exploration of the required lymph node areas, the participant will be considered eligible if no lymph nodes are found in those areas; if participants have documented N2 disease in one level (per the UICC/AJCC staging system, 7th edition; Detterbeck et al. 2009), not all levels need to be sampled; if the preoperative staging imaging results (contrast computed tomography \[CT\] and positron emission tomography \[PET\] scans) do not suggest evidence of disease in the mediastinum, the participant will be considered eligible if N2 nodal sampling is not performed per surgeon's decision * Eligible to receive a cisplatin-based chemotherapy regimen * Adequate hematologic and end-organ function * Women who are not postmenopausal (\>/=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of cisplatin-based chemotherapy Inclusion Criteria for Randomized Phase - Women who are not postmenopausal (\>/=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of atezolizumab or BSC Exclusion Criteria: Exclusion Criteria for Enrollment Phase * Illness or condition that may interfere with a participant's capacity to understand, follow, and/or comply with study procedures * Pregnant and lactating women * Treatment with prior systemic chemotherapy: Chemotherapy for early stage of malignancy with curative intent, provided that the last dose received was more than 5 years prior to enrollment and low-dose chemotherapy for non-malignant conditions may be allowed upon approval by the Medical Monitor * Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years before enrollment * Treatment with any other investigational agent with therapeutic intent within 28 days prior to enrollment * Participants with hearing impairment * Known sensitivity to any component of the chemotherapy regimen the participant will be assigned to, or to mannitol * Prior treatment with cluster of differentiation (CD) 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (PD-1), and anti programmed death ligand 1 (PD-L1) therapeutic antibodies * Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS greater than \[\>\] 90 percent \[%\]) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent) * History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins * Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation * History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis * Positive test for human immunodeficiency virus (HIV) * Participants with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen \[HBsAg\] test at screening) or hepatitis C * Active tuberculosis * Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within the previous 3 months, unstable arrhythmias, or unstable angina * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan * Prior allogeneic bone marrow transplantation or solid organ transplant * Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications * Known tumor PD-L1 expression status as determined by an immunohistochemistry (IHC) assay from other clinical studies (e.g., participants whose PD-L1 expression status was determined during screening for entry into a study with anti-PD-1 or anti-PD-L1 antibodies but were not eligible are excluded) Specific Exclusions for Pemetrexed Treatment \- Participants with squamous cell histology Exclusion Criteria for Randomized Phase * Signs or symptoms of infection within 14 days prior to randomization (severe infection within 28 days prior to randomization), including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia * Received therapeutic oral or intravenous (IV) antibiotics within 14 days prior to randomization * Major surgical procedure within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study * Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation that such a live attenuated vaccine will be required during the study * Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to randomization: Prior treatment with cancer vaccines is allowed * Treatment with systemic corticosteroids or other immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 14 days prior to randomization

Locations (153)

Highlands Oncology Group

Fayetteville, Arkansas, United States

California Cancer Associates for Research & Excellence, Inc.

Encinitas, California, United States

Compassionate Cancer Care Medical Group, Inc

Fountain Valley, California, United States

University of California Los Angeles

Los Angeles, California, United States

Kaiser Permanente

Vallejo, California, United States

Kaiser Permanente - Walnut Creek

Walnut Creek, California, United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States

Lynn Cancer Institute - West

Boca Raton, Florida, United States

University of Miami School of Medicine - Sylvester at Deerfield

Deerfield Beach, Florida, United States

SCRI Florida Cancer Specialists North

St. Petersburg, Florida, United States

Lewis Hall Singletary Oncology Center

Thomasville, Georgia, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Illinois Cancer Care

Peoria, Illinois, United States

Norton Cancer Institute

Louisville, Kentucky, United States

St. Luke's Cancer Institute

Kansas City, Missouri, United States

Hematology Oncology Associates of Northern New Jersey

Florham Park, New Jersey, United States

Saint Barnabas Medical Center

Livingston, New Jersey, United States

Valley Hospital

Paramus, New Jersey, United States

Overlook Medical Center

Summit, New Jersey, United States

Clinical Research Alliance

Lake Success, New York, United States

Weill Cornell Medical College

New York, New York, United States

Presbyterian Hospital

Charlotte, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Oncology Hematology Care - SCRI

Cincinnati, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

University Oncology Associates

Chattanooga, Tennessee, United States

Houston Methodist Cancer Center

Houston, Texas, United States

Wellmont Medical Associates

Bristol, Virginia, United States

Hematology Oncology Associates of Fredericksburg, Inc.

Fredericksburg, Virginia, United States

MultiCare Regional Cancer Center - Auburn

Auburn, Washington, United States

Providence Everett Med Ctr

Everett, Washington, United States

Swedish Medical Center

Seattle, Washington, United States

Townsville Hospital

Douglas, Queensland, Australia

Cabrini Hospital Malvern

Malvern, Victoria, Australia

Cliniques Universitaires St-Luc

Brussels, Belgium

CHU de Liège (Sart Tilman)

Liège, Belgium

Cancer Institute and Hospital Chinese Academy of Medical Sciences

Beijing, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Anhui Province Cancer Hospital

Hefei, China

Shanghai Chest Hospital

Shanghai, China

Shanghai Pulmonary Hospital

Shanghai, China

Liaoning Provincial Cancer Hospital

Shengyang, China

First Hospital of China Medical University

Shenyang, China

First Affiliated Hospital of Soochow University

Suzhou, China

Centre Hospitalier de Mont de Marsan - Hopital Layne

Mont-de-Marsan, France

Clinique Clémentville

Montpellier, France

Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque

Montpellier, France

Centre René Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique

Nantes, France

Centre Hospitalier Regional Sud Reunion

Saint-Pierre, France

Centre Hospitalier de Saint-Quentin

Saint-Quentin, France

Hopital d Instruction des Armees de Sainte Anne

Toulon, France

Ev.Krankenhaus Bielefeld gGmbH

Bielefeld, North Rhine-Westphalia, Germany

Evang. Lungenklinik Berlin Klinik für Pneumologie

Berlin, Germany

Stadtisches Klinikum Braunschweig

Braunschweig, Germany

Klinikum Chemnitz gGmbH

Chemnitz, Germany

Krankenhaus Nordwest

Frankfurt am Main, Germany

LungenClinic Grosshansdorf GmbH

Großhansdorf, Germany

Lungenklinik Hemer

Hemer, Germany

Universität Des Saarlandes

Homburg, Germany

Fachklinik für Lungenerkrankungen

Immenhausen, Germany

Vincentius-Diakonissen-Kliniken gAG

Karlsruhe, Germany

Katholisches Klinikum Marienhof

Koblenz Am Rhein, Germany

Klinikum Bogenhausen

München, Germany

Gemeinschaftspraxis für Hämatologie und Onkologie

Münster, Germany

Pius-Hospital Oldenburg

Oldenburg, Germany

Krankenhaus Barmherzige Bruder Regensburg

Regensburg, Germany

Prince of Wales Hosp

Shatin, Hong Kong

University of Pecs, I st Dept of Internal Medicine

Pécs, Hungary

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.

Szolnok, Hungary

Rambam Medical Center

Haifa, Israel

Edith Wolfson Medical Center

Holon, Israel

Meir Medical Center

Kfar Saba, Israel

Tel Aviv Sourasky Medical Ctr

Tel Aviv, Israel

Chaim Sheba Medical Center

Tel Litwinsky, Israel

Ospedale Clinicizzato SS Annunziata

Chieti, Abruzzo, Italy

Azienda per l'Assistenza Sanitaria N° 5 - Friuli Occidentale

Pordenone, Friuli Venezia Giulia, Italy

Policlinico Universitario Campus Biomedico Di Roma

Rome, Lazio, Italy

Asst Papa Giovanni XXIII

Bergamo, Lombardy, Italy

ASST Spedali Civili di Brescia

Brescia, Lombardy, Italy

Azienda Sanitaria Ospedaliera S Luigi Gonzaga

Orbassano, Piedmont, Italy

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Turin, Piedmont, Italy

Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi

Catania, Sicily, Italy

Ospedale Santa Chiara

Trento, Trentino-Alto Adige, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, Italy

Ospedale Silvestrini

Perugia, Umbria, Italy

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Veneto, Italy

Aichi Cancer Center Hospital

Aichi, Japan

Hyogo Cancer Center

Akashi, Japan

Juntendo University Hospital

Bunkyō City, Japan

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Bunkyō City, Japan

National Cancer Center Hospital

Chūō, Japan

Kyushu University Hospital

Fukuoka, Japan

Hiroshima University Hospital

Hiroshima, Japan

Saitama Cancer Center

Kitaadachi-gun, Japan

Hospital of the University of Occupational and Environmental Health,Japan

Kitakyushu-shi, Japan

Kumamoto University Hospital

Kumamoto, Japan

Kyoto University Hospital

Kyoto, Japan

Shikoku Cancer Center

Matsuyama, Japan

Kyorin University Hospital

Mitaka-shi, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Okayama University Hospital

Okayama, Japan

National Hospital Organization Hokkaido Cancer Center

Sapporo, Japan

Toranomon Hospital

Tokyo, Japan

Tokyo Medical University Hospital

Tokyo, Japan

Kanagawa Cancer Center

Yokohama-shi, Asahi-ku, Japan

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, North Brabant, Netherlands

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, Netherlands

Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

Otwock, Poland

Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

Poznan, Poland

Centro Hospitalar E Universitário de Coimbra EPE

Coimbra, Portugal

Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

Porto, Portugal

Hospital de Sao Joao

Porto, Portugal

Oncology Center Sf. Nectarie

Craiova, Romania

Principal Military Clinical Hospital n.a. N.N. Burdenko

Moscow, Moscow Oblast, Russia

Leningrad Regional Clinical Hospital

Saint Petersburg, Sankt-Peterburg, Russia

GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)

Saint Petersburg, Sankt-Peterburg, Russia

Scientific Research Institute of Oncology n.a. N.N. Petrov

Saint Petersburg, Sankt-Peterburg, Russia

City Clinical Hospital #1

Novosibirsk, Russia

Volgograd Regional Clinical Oncology Dispensary

Volgograd, Russia

Regional Clinical Oncology Hospital

Yaroslavl, Russia

Chonnam National University Hwasun Hospital

Jeonnam, South Korea

The Catholic University of Korea St. Vincent's Hospital

Suwon, South Korea

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Consorcio Hospitalario Provincial de Castellon

Castellon, Castellon, Spain

Hospital Universitario Virgen de La Arrixaca

El Palmar, Murcia, Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, Spain

Hospital del Mar

Barcelona, Spain

Hospital Santa Creu i Sant Pau

Barcelona, Spain

Vall d'Hebron Institute of Oncology (VHIO), Barcelona

Barcelona, Spain

C.H. Regional Reina Sofia

Córdoba, Spain

Complejo Hospitalario de Jaen

Jaén, Spain

Hospital Lucus Augusti

Lugo, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario HM Sanchinarro-CIOCC

Madrid, Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain

Hosp Clinico Univ Lozano Blesa

Zaragoza, Spain

Changhua Christian Hospital

Changhua, Taiwan

Chang Gung Memorial Hospital Chiayi

Putzui City, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Chang Gung Medical Foundation Linkou Branch

Taoyuan, Taiwan

MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council

Dnipropetrovsk, Katerynoslav Governorate, Ukraine

Communal Non profit Enterprise Regional Center of Oncology

Kharkiv, Kharkiv Governorate, Ukraine

Municipal Institution Odesa Regional Oncology Dispensary

Odesa, KIEV Governorate, Ukraine

Municipal Institution SubCarpathian ClinicalOncological Centre

Ivano-Frankivsk, Poltava Governorate, Ukraine

Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council

Vinnytsia, Vinnytsia Oblast, Ukraine

CE Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council

Kryvyi Rih, Ukraine

Kyiv City Clinical Oncological Center

Kyiv, Ukraine

Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

Sumy, Ukraine

MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology

Zaporizhzhya, Ukraine

Colchester General Hospital

Colchester, Essex, United Kingdom

St Bartholomew's Hospital

London, United Kingdom

Clinical Research Directory

Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (153)