AzTrials
AzTrials

Non-Small Cell Lung CancerPhase 3NCT02486718

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

A Phase 3 study testing Atezolizumab, Cisplatin and Vinorelbine in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 216 sites in 22 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 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Atezolizumab, Cisplatin and Vinorelbine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,280 participants
Where
216 sitesin 22 countries
Study dates
31 Oct 2015to 26 Aug 2026
Phase
Phase 3

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

  • 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

Who cannot join

  • 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
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  • 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
  • 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

Trial locations and contacts

216 sites in 22 countries.

216 sites in 22 countries

United States45 sites

  • MultiCare Regional Cancer Center - Auburn

    Auburn, Washington, 98002-4117

  • Lynn Cancer Institute - West

    Boca Raton, Florida, 33486

  • Wellmont Medical Associates

    Bristol, Virginia, 24201

  • Presbyterian Hospital

    Charlotte, North Carolina, 28204

  • Sarah Cannon Research Institute / Tennessee Oncology

    Chattanooga, Tennessee, 37403

  • University Oncology Associates

    Chattanooga, Tennessee, 37403

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • Oncology Hematology Care - SCRI

    Cincinnati, Ohio, 45242

  • University of Miami School of Medicine - Sylvester at Deerfield

    Deerfield Beach, Florida, 33442

  • California Cancer Associates for Research & Excellence, Inc.

    Encinitas, California, 92024

  • Providence Everett Med Ctr

    Everett, Washington, 98201

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • Hematology Oncology Associates of Northern New Jersey

    Florham Park, New Jersey, 07932

  • Holy Cross Hospital Inc

    Fort Lauderdale, Florida, 33308

  • Florida Cancer Specialists-Broadway, Fort Myers

    Fort Myers, Florida, 33916

  • Compassionate Cancer Care Medical Group, Inc

    Fountain Valley, California, 92708

  • Hematology Oncology Associates of Fredericksburg, Inc.

    Fredericksburg, Virginia, 22408

  • Pinnacle Health

    Harrisburg, Pennsylvania, 17109

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89052

  • Houston Methodist Cancer Center

    Houston, Texas, 77030

  • St. Luke's Cancer Institute

    Kansas City, Missouri, 64111

  • Clinical Research Alliance

    Lake Success, New York, 11042

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • University of California Los Angeles

    Los Angeles, California, 90024

  • Southern California Permanente Medical Group Bellflower

    Los Angeles, California, 90027

  • Norton Cancer Institute

    Louisville, Kentucky, 40402

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

    Marietta, Georgia, 30060

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203

  • Weill Cornell Medical College

    New York, New York, 10065

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut, 06360

  • Valley Hospital

    Paramus, New Jersey, 07652

  • Illinois Cancer Care

    Peoria, Illinois, 61615

  • AHN Cancer Institute ? Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Swedish Medical Center

    Seattle, Washington, 98122

  • Southern Illinois University, Simmons Cancer Institute

    Springfield, Illinois, 62794

  • SCRI Florida Cancer Specialists North

    St. Petersburg, Florida, 33705

  • Stanford University

    Stanford, California, 94305

  • Overlook Medical Center

    Summit, New Jersey, 07901

  • Lewis Hall Singletary Oncology Center

    Thomasville, Georgia, 31792

  • Kaiser Permanente

    Vallejo, California, 94589

  • Kaiser Permanente - Walnut Creek

    Walnut Creek, California, 94596

Other trials in United States

Japan24 sites

  • Aichi Cancer Center Hospital

    Aichi, 464-8681

  • Hyogo Cancer Center

    Akashi, 673-0021

  • Juntendo University Hospital

    Bunkyō City, 113-8431

  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

    Bunkyō City, 113-8677

  • National Cancer Center East

    Chiba, 277-8577

  • National Cancer Center Hospital

    Chūō, 104-0045

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Saitama Cancer Center

    Kitaadachi-gun, 362-0806

  • Hospital of the University of Occupational and Environmental Health,Japan

    Kitakyushu-shi, 807-8555

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Kyoto University Hospital

    Kyoto, 606-8507

  • Shikoku Cancer Center

    Matsuyama, 791-0280

  • Kyorin University Hospital

    Mitaka-shi, 181-0004

  • Nagoya University Hospital

    Nagoya, 466-8560

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Okayama University Hospital

    Okayama, 700-8558

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, 003-0804

  • Sendai Kousei Hospital

    Sendai, Miyagi, 981-0914

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

  • Toranomon Hospital

    Tokyo, 105-8470

  • Tokyo Medical University Hospital

    Tokyo, 160-0023

  • Wakayama Medical University Hospital

    Wakayama, 641-8510

  • Kanagawa Cancer Center

    Yokohama-shi, Asahi-ku, 241-8515

Other trials in Japan

Germany22 sites

  • Evang. Lungenklinik Berlin Klinik für Pneumologie

    Berlin, 13125

  • Ev.Krankenhaus Bielefeld gGmbH

    Bielefeld, North Rhine-Westphalia, 33611

  • Stadtisches Klinikum Braunschweig

    Braunschweig, 38114

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09113

  • Kliniken der Stadt Koln gGmbH

    Cologne, 51109

  • Krankenhaus Nordwest

    Frankfurt am Main, 60488

  • LungenClinic Grosshansdorf GmbH

    Großhansdorf, 22927

  • Krankenhaus Martha-Maria

    Halle, 06120

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Asklepios Klinik Harburg

    Hamburg, 21075

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, 69126

  • Lungenklinik Hemer

    Hemer, 58675

  • Universität Des Saarlandes

    Homburg, 66421

  • Fachklinik für Lungenerkrankungen

    Immenhausen, 34376

  • Vincentius-Diakonissen-Kliniken gAG

    Karlsruhe, 76137

  • Katholisches Klinikum Marienhof

    Koblenz Am Rhein, 56073

  • SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein

    Löwenstein, Baden-Wurttemberg, 74245

  • Klinikum Bogenhausen

    München, 81925

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Münster, 48149

  • Pius-Hospital Oldenburg

    Oldenburg, 26121

  • Krankenhaus Barmherzige Bruder Regensburg

    Regensburg, 93049

  • Praxis fur Hamatologie und internistische Onkologie

    Velbert, 42551

Other trials in Germany

Spain20 sites

  • Centro Oncologico de Galicia COG

    A Coruña, LA Coruna, 15009

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08025

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

    Barcelona, 08035

  • Hospital Universitari Germans Trias i Pujol

    Barcelona, 08916

  • Consorcio Hospitalario Provincial de Castellon

    Castellon, Castellon, 12002

  • C.H. Regional Reina Sofia

    Córdoba, 14004

  • Hospital Universitario Virgen de La Arrixaca

    El Palmar, Murcia, 30120

  • Complejo Hospitalario de Jaen

    Jaén, 23007

  • Hospital Lucus Augusti

    Lugo, 27003

  • Hospital Ramon y Cajal

    Madrid, 28034

  • Hosp. Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario HM Sanchinarro-CIOCC

    Madrid, 28050

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07010

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Tenerife, 3820

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

  • Hosp Clinico Univ Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Italy15 sites

  • Asst Papa Giovanni XXIII

    Bergamo, Lombardy, 24127

  • ASST Spedali Civili di Brescia

    Brescia, Lombardy, 25123

  • Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi

    Catania, Sicily, 95122

  • Ospedale Clinicizzato SS Annunziata

    Chieti, Abruzzo, 66013

  • Azienda Sanitaria Ospedaliera s. Croce e Carle

    Cuneo, Piedmont, 12100

  • Ospedale San Raffaele

    Milan, Lombardy, 20132

  • A.O.U. Maggiore della Carità

    Novara, Piedmont, 28100

  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga

    Orbassano, Piedmont, 10043

  • Ospedale Silvestrini

    Perugia, Umbria, 06132

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany, 56124

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

    Pordenone, Friuli Venezia Giulia, 33170

  • Policlinico Universitario Campus Biomedico Di Roma

    Rome, Lazio, 00128

  • Ospedale Santa Chiara

    Trento, Trentino-Alto Adige, 38100

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Turin, Piedmont, 10126

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, Veneto, 37126

Other trials in Italy

Russia14 sites

  • Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

    Kazan', Tatarstan Republic, 420029

  • Moscow City Oncology Hospital #62

    Moscovskaya Oblast, Moscow Oblast, 143423

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

    Moscow, Moscow Oblast, 105229

  • Russian Oncology Research Center n a N N Blokhin

    Moscow, Moscow Oblast, 115478

  • City Clinical Hospital #1

    Novosibirsk, 630047

  • Evromedservis LCC

    Pushkin, Sankt-Peterburg, 196603

  • Leningrad Regional Clinical Hospital

    Saint Petersburg, Sankt-Peterburg, 194291

  • St. Petersburg Med Univ

    Saint Petersburg, Sankt-Peterburg, 197022

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

    Saint Petersburg, Sankt-Peterburg, 197758

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

    Saint Petersburg, Sankt-Peterburg, 197758

  • City Clinical Oncology Dispensary

    Saint Petersburg, Sankt-Peterburg, 198255

  • Mordovia State University

    Saransk, Respublika Mordoviya, 430032

  • Volgograd Regional Clinical Oncology Dispensary

    Volgograd, 400138

  • Regional Clinical Oncology Hospital

    Yaroslavl, 150040

Other trials in Russia

China12 sites

  • Cancer Institute and Hospital Chinese Academy of Medical Sciences

    Beijing, 100021

  • Beijing Cancer Hospital

    Beijing, 100142

  • Chinese People's Liberation Army (PLA) General Hospital (301 Hospital)

    Beijing, 100853

  • Affiliated Hospital of Guangdong Medical University

    Guangdong, 524023

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Anhui Province Cancer Hospital

    Hefei

  • Shanghai Chest Hospital

    Shanghai, 200030

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

  • Liaoning Provincial Cancer Hospital

    Shengyang, 110042

  • First Hospital of China Medical University

    Shenyang, 110001

  • First Affiliated Hospital of Soochow University

    Suzhou, 215006

Other trials in China

France12 sites

  • Hôpital Universitaire Dupuytren

    Limoges, 87042

  • Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

    Lyon, 69373

  • Hôpital Saint Joseph

    Marseille, 13008

  • Centre Hospitalier de Mont de Marsan - Hopital Layne

    Mont-de-Marsan, 40000

  • Clinique Clémentville

    Montpellier, 34070

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

    Montpellier, 34298

  • Centre René Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique

    Nantes, 44093

  • Hopital d'Instruction des Armees de Begin

    Saint-Mandé, 94160

  • Centre Hospitalier Regional Sud Reunion

    Saint-Pierre, 97448

  • Centre Hospitalier de Saint-Quentin

    Saint-Quentin, 02321

  • Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer

    Toulon, 83000

  • Hopital d Instruction des Armees de Sainte Anne

    Toulon, 83041

Other trials in France

Ukraine11 sites

  • MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council

    Dnipropetrovsk, Katerynoslav Governorate, 49102

  • Municipal Institution SubCarpathian ClinicalOncological Centre

    Ivano-Frankivsk, Poltava Governorate, 76018

  • Communal Non profit Enterprise Regional Center of Oncology

    Kharkiv, Kharkiv Governorate, 61070

  • Private Enterprise Private Manufacturing Company Acinus

    Kropyvnytskyi, KIEV Governorate, 25006

  • CE Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council

    Kryvyi Rih, 50048

  • Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway

    Kyiv, KIEV Governorate, 02096

  • Kyiv City Clinical Oncological Center

    Kyiv, 03115

  • Municipal Institution Odesa Regional Oncology Dispensary

    Odesa, KIEV Governorate, 65055

  • Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

    Sumy, 40022

  • Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council

    Vinnytsia, Vinnytsia Oblast, 21018

  • MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology

    Zaporizhzhya, 69040

Other trials in Ukraine

Taiwan9 sites

  • Changhua Christian Hospital

    Changhua, 500

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 807

  • Chang Gung Memorial Hospital Chiayi

    Putzui City, 61363

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Chi Mei Medical Center Liou Ying Campus

    Tainan, 736

  • Taipei Veterans General Hospital

    Taipei, 00112

  • National Taiwan Uni Hospital

    Taipei, 10048

  • Mackay Memorial Hospital

    Taipei, 104

  • Chang Gung Medical Foundation Linkou Branch

    Taoyuan City, 333

Other trials in Taiwan

Israel6 sites

  • Rambam Medical Center

    Haifa, 31096

  • Edith Wolfson Medical Center

    Holon, 58100

  • Meir Medical Center

    Kfar Saba, 44281

  • Rabin Medical Center

    Petah Tikva, 49100

  • Tel Aviv Sourasky Medical Ctr

    Tel Aviv, 64239

  • Chaim Sheba Medical Center

    Tel Litwinsky, 52621

Other trials in Israel

Hungary4 sites

  • Semmelweis Egyetem

    Budapest, 1125

  • University of Pecs, I st Dept of Internal Medicine

    Pécs, 7624

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

    Szolnok, 5004

  • Reformatus Pulmonologiai Centrum

    Törökbálint, 2045

Other trials in Hungary

Portugal4 sites

  • Centro Hospitalar E Universitário de Coimbra EPE

    Coimbra, 3000-602

  • Centro Hospitalar de Lisboa Norte E.P.E ? Hospital Pulido Valente

    Lisbon, 1769-001

  • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

    Porto, 4200-072

  • Hospital de Sao Joao

    Porto, 4200-319

Other trials in Portugal

Netherlands3 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, North Brabant, 5223 GZ

  • Martini Ziekenhuis

    Groningen, 9728 NT

  • St. Antonius Ziekenhuis Nieuwegein

    Nieuwegein, 3430 EM

Other trials in Netherlands

United Kingdom3 sites

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

  • Colchester General Hospital

    Colchester, Essex, CO4 5JL

  • St Bartholomew's Hospital

    London, EC1A 7BE

Other trials in United Kingdom

Australia2 sites

  • Townsville Hospital

    Douglas, Queensland, 4814

  • Cabrini Hospital Malvern

    Malvern, Victoria, 3144

Other trials in Australia

Belgium2 sites

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • CHU de Liège (Sart Tilman)

    Liège, 4000

Other trials in Belgium

Canada2 sites

  • William Osler Health Centre

    Brampton, Ontario, L6R 3J7

  • Cite de La Sante de Laval

    Laval, Quebec, H7M 3L9

Other trials in Canada

Poland2 sites

  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

    Otwock, 05-400

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

    Poznan, 60569

Other trials in Poland

South Korea2 sites

  • Chonnam National University Hwasun Hospital

    Jeonnam, 519-763

  • The Catholic University of Korea St. Vincent's Hospital

    Suwon, 442-723

Other trials in South Korea

Hong Kong1 site

  • Prince of Wales Hosp

    Shatin

Other trials in Hong Kong

Romania1 site

  • Oncology Center Sf. Nectarie

    Craiova, 200542

Other trials in Romania

About this study

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

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.

Being tested
Atezolizumab, Cisplatin, Vinorelbine, Docetaxel, Gemcitabine
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • AtezolizumabDrug

    Also called MPDL3280A; TECENTRIQ

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

  • CisplatinDrug

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

  • VinorelbineDrug

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

  • DocetaxelDrug

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

  • GemcitabineDrug

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

  • PemetrexedDrug

    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.

Study groups in NCT02486718
Study groupRoleWhat they receive
AtezolizumabExperimentalEnrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed [non-squamous cell NSCLC only]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: Participants will receive atezolizumab 1200 milligrams (mg) intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles and will undergo periodic chest X-ray and CT scan.
Receives: Drug: Atezolizumab; Drug: Cisplatin; Drug: Vinorelbine; Drug: Docetaxel; Drug: Gemcitabine; Drug: Pemetrexed
Best Supportive CareActive comparatorEnrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed [non-squamous cell NSCLC only]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: After enrollment phase participants will receive only the best supportive care and will undergo periodic chest X-ray and CT scan.
Receives: Drug: Cisplatin; Drug: Vinorelbine; Drug: Docetaxel; Drug: Gemcitabine; Drug: Pemetrexed

What is being measured

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

  1. Disease-Free Survival (DFS) in Intent-to-treat (ITT) Population

    DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.

    Measured: Up to 95 months

  2. DFS in All Randomized Stage II-IIIA Population

    DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in participants with disease stage II-IIIA. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.

    Measured: Up to 95 months

  3. DFS in the Programmed Death-ligand 1 (PD-L1) SP263 ≥ 1% Tumor Cell (TC) Subpopulation Within the Stage II-IIIA Population

    DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in PD-L1 ≥1% subpopulation within the Stage II-IIIA population. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.

    Measured: Up to 95 months

Secondary outcomes (12)

  1. Overall Survival (OS) in the ITT Population

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

    Measured: Baseline up to death from any cause (up to approximately 126 months)

  2. Disease-free Rate at Year 3 in ITT Population

    DFS rate was defined as percentage of participants who were disease-free at Year 3. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.

    Measured: Year 3

  3. Disease-free Rate at Year 3 in All Randomized Stage II-IIIA Population

    DFS rate was defined as percentage of participants who were disease-free at Year 3. DFS rate was analyzed in participants with disease stage II-IIIA. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.

    Measured: Year 3

  4. Disease-free Rate at Year 3 in PD-L1 (SP263 ≥ 1% TC) Subpopulation Within the Stage II-IIIA Population

    DFS rate was defined as percentage of participants who were disease-free at Year 3. DFS rate was analyzed in PD-L1 subpopulation within the Stage II-IIIA population. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.

    Measured: Year 3

  5. Disease-free Rate at Year 5 in ITT Population

    DFS rate was defined as percentage of participants who were disease-free at Year 5. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.

    Measured: Year 5

  6. Disease-free Rate at Year 5 in All Randomized Stage II-IIIA Population

    DFS rate was defined as percentage of participants who were disease-free at Year 5. DFS rate was analyzed in participants with disease stage II-IIIA. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.

    Measured: Year 5

  7. Disease-free Rate at Year 5 in PD-L1 (SP263 ≥ 1% TC) Subpopulation Within the Stage II-IIIA Population

    DFS rate was defined as percentage of participants who were disease-free at Year 5. DFS rate was analyzed in PD-L1 subpopulation within the Stage II-IIIA population. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.

    Measured: Year 5

  8. DFS in the PD-L1 (SP263 ≥ 50% TC) Subpopulation Within the Stage II-IIIA Population

    DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in PD-L1 subpopulation within the Stage II-IIIA population. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.

    Measured: Up to 95 months

  9. Percentage of Participants With Adverse Events (AEs)

    An AE is any untoward medical occurrence in a participant when administered a pharmaceutical product regardless of the causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product.

    Measured: Up to 12 years

  10. Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab

    The percentage of ATA (Also called anti-drug antibodies (ADA))-positive participants after drug administration were determined for participants exposed to atezolizumab. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the baseline titer result.

    Measured: Predose (Hour 0) on Day 1 of Cycles 2, 3, 4, 8, 16 (Cycle length = 21 days), at treatment discontinuation (TD) (up to 12 months), 120 days after last atezolizumab administration (up to 16 months)

  11. Maximum Plasma Concentration (Cmax) of Atezolizumab

    Measured: 30 min post-infusion on Day 1 of Cycle 1 (Cycle length = 21 days)

  12. Minimum Serum Concentration (Cmin) at Steady-State Within a Dosing Interval of Atezolizumab

    Measured: Prior to infusion on Day 1 of Cycles 1, 2, 3, 4, 8, 16 (Cycle length = 21 days), at study discontinuation visit (up to 12 months), Day 120 post last dose of atezolizumab (up to 16 months)

Timeline

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

  1. First posted1 Jul 2015 (estimated)
  2. Study start31 Oct 2015
  3. Primary completion26 Jan 2024
  4. Study completion26 Aug 2026

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
None (open label)
Enrolment
1,280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02486718
Sponsor's protocol ID
GO29527
Other IDs
2014-003205-15, 2023-505981-26-00, 2023, 2014
Status last verified
Sep 2026
First submitted
4 Jun 2015
Last updated
30 Sep 2026
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Publications

  • Okada M, Sugawara S, Watanabe Y, Saito H, Chen-Yoshikawa TF, Goto Y, Nishio W, Nakagawa S, Hayashi M, Kenmotsu H. IMpower010: 5-Year Outcomes of Atezolizumab in Japanese Patients With Resected Stage IB-IIIA Non-Small Cell Lung Cancer. Cancer Sci. 2026 Mar;117(3):749-758. doi: 10.1111/cas.70297. Epub 2025 Dec 19.

    PubMed 41416818

  • Felip E, Altorki N, Zhou C, Vallieres E, Csoszi T, Vynnychenko IO, Goloborodko O, Rittmeyer A, Reck M, Martinez-Marti A, Kenmotsu H, Chen YM, Chella A, Sugawara S, Fu C, Ballinger M, Deng Y, Srivastava MK, Bennett E, Gitlitz BJ, Wakelee HA; IMpower010 Study Investigators. Five-Year Survival Outcomes With Atezolizumab After Chemotherapy in Resected Stage IB-IIIA Non-Small Cell Lung Cancer (IMpower010): An Open-Label, Randomized, Phase III Trial. J Clin Oncol. 2025 Jul 20;43(21):2343-2349. doi: 10.1200/JCO-24-01681. Epub 2025 May 30.

    PubMed 40446184

  • Zhou C, Srivastava MK, Xu H, Felip E, Wakelee H, Altorki N, Reck M, Liersch R, Kryzhanivska A, Oizumi S, Tanaka H, Hamm J, McCune SL, Bennett E, Gitlitz B, McNally V, Ballinger M, McCleland M, Zou W, Das Thakur M, Novello S. Comparison of SP263 and 22C3 immunohistochemistry PD-L1 assays for clinical efficacy of adjuvant atezolizumab in non-small cell lung cancer: results from the randomized phase III IMpower010 trial. J Immunother Cancer. 2023 Oct;11(10):e007047. doi: 10.1136/jitc-2023-007047.

    PubMed 37903590

  • Felip E, Altorki N, Zhou C, Vallieres E, Martinez-Marti A, Rittmeyer A, Chella A, Reck M, Goloborodko O, Huang M, Belleli R, McNally V, Srivastava MK, Bennett E, Gitlitz BJ, Wakelee HA. Overall survival with adjuvant atezolizumab after chemotherapy in resected stage II-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase III trial. Ann Oncol. 2023 Oct;34(10):907-919. doi: 10.1016/j.annonc.2023.07.001. Epub 2023 Jul 17.

    PubMed 37467930

  • Mohindra NA, Patel JD. Top advances in lung cancer, 2021. Cancer. 2022 Oct 1;128(19):3434-3437. doi: 10.1002/cncr.34406. Epub 2022 Aug 10.

    PubMed 35947027

  • Felip E, Altorki N, Zhou C, Csoszi T, Vynnychenko I, Goloborodko O, Luft A, Akopov A, Martinez-Marti A, Kenmotsu H, Chen YM, Chella A, Sugawara S, Voong D, Wu F, Yi J, Deng Y, McCleland M, Bennett E, Gitlitz B, Wakelee H; IMpower010 Investigators. Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2021 Oct 9;398(10308):1344-1357. doi: 10.1016/S0140-6736(21)02098-5. Epub 2021 Sep 20.

    PubMed 34555333

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