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

April 28, 2026 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1280

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Douglas, Queensland, Australia, 4814
        • Townsville Hospital
    • Victoria
      • Malvern, Victoria, Australia, 3144
        • Cabrini Hospital Malvern
  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires St-Luc
      • Liège, Belgium, 4000
        • CHU de Liège (Sart Tilman)
  • China
      • Beijing, China, 100021
        • Cancer Institute and Hospital Chinese Academy of Medical Sciences
      • Guangzhou, China, 510120
        • The First Affiliated Hospital of Guangzhou Medical University
      • Hangzhou, China, 310022
        • Zhejiang Cancer Hospital
      • Hefei, China
        • Anhui Province Cancer Hospital
      • Shanghai, China, 200030
        • Shanghai Chest Hospital
      • Shanghai, China, 200433
        • Shanghai Pulmonary Hospital
      • Shengyang, China, 110042
        • Liaoning Provincial Cancer Hospital
      • Shenyang, China, 110001
        • First Hospital of China Medical University
      • Suzhou, China, 215006
        • First Affiliated Hospital of Soochow University
  • France
      • Mont-de-Marsan, France, 40000
        • Centre Hospitalier de Mont de Marsan - Hopital Layne
      • Montpellier, France, 34070
        • Clinique Clémentville
      • Montpellier, France, 34298
        • Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque
      • Nantes, France, 44093
        • Centre René Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique
      • Saint-Pierre, France, 97448
        • Centre Hospitalier Regional Sud Reunion
      • Saint-Quentin, France, 02321
        • Centre Hospitalier de Saint-Quentin
      • Toulon, France, 83041
        • Hopital d Instruction des Armees de Sainte Anne
  • Germany
      • Berlin, Germany, 13125
        • Evang. Lungenklinik Berlin Klinik für Pneumologie
      • Braunschweig, Germany, 38114
        • Städtisches Klinikum Braunschweig
      • Chemnitz, Germany, 09113
        • Klinikum Chemnitz gGmbH
      • Frankfurt am Main, Germany, 60488
        • Krankenhaus Nordwest
      • Großhansdorf, Germany, 22927
        • LungenClinic Grosshansdorf GmbH
      • Hemer, Germany, 58675
        • Lungenklinik Hemer
      • Homburg, Germany, 66421
        • Universität des Saarlandes
      • Immenhausen, Germany, 34376
        • Fachklinik für Lungenerkrankungen
      • Karlsruhe, Germany, 76137
        • Vincentius-Diakonissen-Kliniken gAG
      • Koblenz Am Rhein, Germany, 56073
        • Katholisches Klinikum Marienhof
      • München, Germany, 81925
        • Klinikum Bogenhausen
      • Münster, Germany, 48149
        • Gemeinschaftspraxis für Hämatologie und Onkologie
      • Oldenburg, Germany, 26121
        • Pius-Hospital Oldenburg
      • Regensburg, Germany, 93049
        • Krankenhaus Barmherzige Brüder Regensburg
    • North Rhine-Westphalia
      • Bielefeld, North Rhine-Westphalia, Germany, 33611
        • Ev.Krankenhaus Bielefeld gGmbH
  • Hong Kong
      • Shatin, Hong Kong
        • Prince of Wales Hosp
  • Hungary
      • Pécs, Hungary, 7624
        • University of Pecs, I st Dept of Internal Medicine
      • Szolnok, Hungary, 5004
        • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Holon, Israel, 58100
        • Edith Wolfson Medical Center
      • Kfar Saba, Israel, 44281
        • Meir Medical Center
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Ctr
      • Tel Litwinsky, Israel, 52621
        • Chaim Sheba Medical Center
  • Italy
    • Abruzzo
      • Chieti, Abruzzo, Italy, 66013
        • Ospedale Clinicizzato SS Annunziata
    • Friuli Venezia Giulia
      • Pordenone, Friuli Venezia Giulia, Italy, 33170
        • Azienda per l'Assistenza Sanitaria N° 5 - Friuli Occidentale
    • Lazio
      • Rome, Lazio, Italy, 00128
        • Policlinico Universitario Campus Biomedico Di Roma
    • Lombardy
      • Bergamo, Lombardy, Italy, 24127
        • ASST Papa Giovanni XXIII
      • Brescia, Lombardy, Italy, 25123
        • ASST Spedali Civili di Brescia
    • Piedmont
      • Orbassano, Piedmont, Italy, 10043
        • Azienda Sanitaria Ospedaliera S Luigi Gonzaga
      • Turin, Piedmont, Italy, 10126
        • Azienda Ospedaliera Città della Salute e della Scienza di Torino
    • Sicily
      • Catania, Sicily, Italy, 95122
        • Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
    • Trentino-Alto Adige
      • Trento, Trentino-Alto Adige, Italy, 38100
        • Ospedale Santa Chiara
    • Tuscany
      • Pisa, Tuscany, Italy, 56124
        • Azienda Ospedaliero Universitaria Pisana
    • Umbria
      • Perugia, Umbria, Italy, 06132
        • Ospedale Silvestrini
    • Veneto
      • Verona, Veneto, Italy, 37126
        • Azienda Ospedaliera Universitaria Integrata Verona
  • Japan
      • Aichi, Japan, 464-8681
        • Aichi Cancer Center Hospital
      • Akashi, Japan, 673-0021
        • Hyogo Cancer Center
      • Bunkyō City, Japan, 113-8431
        • Juntendo University Hospital
      • Bunkyō City, Japan, 113-8677
        • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
      • Chūō, Japan, 104-0045
        • National Cancer Center Hospital
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital
      • Kitaadachi-gun, Japan, 362-0806
        • Saitama Cancer Center
      • Kitakyushu-shi, Japan, 807-8555
        • Hospital of the University of Occupational and Environmental Health,Japan
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital
      • Kyoto, Japan, 606-8507
        • Kyoto University Hospital
      • Matsuyama, Japan, 791-0280
        • Shikoku Cancer Center
      • Mitaka-shi, Japan, 181-0004
        • Kyorin University Hospital
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
      • Sapporo, Japan, 003-0804
        • National Hospital Organization Hokkaido Cancer Center
      • Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital
      • Tokyo, Japan, 105-8470
        • Toranomon Hospital
      • Yokohama-shi, Asahi-ku, Japan, 241-8515
        • Kanagawa Cancer Center
  • Netherlands
      • Nieuwegein, Netherlands, 3430 EM
        • St. Antonius Ziekenhuis Nieuwegein
    • North Brabant
      • 's-Hertogenbosch, North Brabant, Netherlands, 5223 GZ
        • Jeroen Bosch Ziekenhuis
  • Poland
      • Otwock, Poland, 05-400
        • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
      • Poznan, Poland, 60569
        • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
  • Portugal
      • Coimbra, Portugal, 3000-602
        • Centro Hospitalar E Universitario de Coimbra EPE
      • Porto, Portugal, 4200-319
        • Hospital de Sao Joao
      • Porto, Portugal, 4200-072
        • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
  • Romania
      • Craiova, Romania, 200542
        • Oncology Center Sf. Nectarie
  • Russia
      • Novosibirsk, Russia, 630047
        • City Clinical Hospital #1
      • Volgograd, Russia, 400138
        • Volgograd Regional Clinical Oncology Dispensary
      • Yaroslavl, Russia, 150040
        • Regional Clinical Oncology Hospital
    • Moscow Oblast
      • Moscow, Moscow Oblast, Russia, 105229
        • Principal Military Clinical Hospital n.a. N.N. Burdenko
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 194291
        • Leningrad Regional Clinical Hospital
      • Saint Petersburg, Sankt-Peterburg, Russia, 197758
        • GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
      • Saint Petersburg, Sankt-Peterburg, Russia, 197758
        • Scientific Research Institute of Oncology n.a. N.N. Petrov
  • South Korea
      • Jeonnam, South Korea, 519-763
        • Chonnam National University Hwasun Hospital
      • Suwon, South Korea, 442-723
        • The Catholic University of Korea St. Vincent's Hospital
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08025
        • Hospital Santa Creu i Sant Pau
      • Barcelona, Spain, 08035
        • Vall d'Hebron Institute of Oncology (VHIO), Barcelona
      • Córdoba, Spain, 14004
        • C.H. Regional Reina Sofia
      • Jaén, Spain, 23007
        • Complejo Hospitalario de Jaen
      • Lugo, Spain, 27003
        • Hospital Lucus Augusti
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28050
        • Hospital Universitario HM Sanchinarro-CIOCC
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe de Valencia
      • Zaragoza, Spain, 50009
        • Hosp Clinico Univ Lozano Blesa
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
    • Castellon
      • Castellon, Castellon, Spain, 12002
        • Consorcio Hospitalario Provincial de Castellon
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Hospital Universitario Virgen de La Arrixaca
    • Tenerife
      • San Cristóbal de La Laguna, Tenerife, Spain, 3820
        • Hospital Universitario de Canarias
  • Taiwan
      • Changhua, Taiwan, 500
        • Changhua Christian Hospital
      • Putzui City, Taiwan, 61363
        • Chang Gung Memorial Hospital Chiayi
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 00112
        • Taipei Veterans General Hospital
      • Taoyuan City, Taiwan, 333
        • Chang Gung Medical Foundation Linkou Branch
  • Ukraine
      • Kryvyi Rih, Ukraine, 50048
        • CE Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council
      • Kyiv, Ukraine, 03115
        • Kyiv City Clinical Oncological Center
      • Sumy, Ukraine, 40022
        • Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
      • Zaporizhzhya, Ukraine, 69040
        • MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology
    • KIEV Governorate
      • Odesa, KIEV Governorate, Ukraine, 65055
        • Municipal Institution Odesa Regional Oncology Dispensary
    • Katerynoslav Governorate
      • Dnipropetrovsk, Katerynoslav Governorate, Ukraine, 49102
        • MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council
    • Kharkiv Governorate
      • Kharkiv, Kharkiv Governorate, Ukraine, 61070
        • Communal Non profit Enterprise Regional Center of Oncology
    • Poltava Governorate
      • Ivano-Frankivsk, Poltava Governorate, Ukraine, 76018
        • Municipal Institution SubCarpathian ClinicalOncological Centre
    • Vinnytsia Oblast
      • Vinnytsia, Vinnytsia Oblast, Ukraine, 21018
        • Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council
  • United Kingdom
      • Colchester, Essex, United Kingdom, CO4 5JL
        • Colchester General Hospital
      • London, United Kingdom, EC1A 7BE
        • St Bartholomew's Hospital
  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Highlands Oncology Group
    • California
      • Encinitas, California, United States, 92024
        • California Cancer Associates for Research & Excellence, Inc.
      • Fountain Valley, California, United States, 92708
        • Compassionate Cancer Care Medical Group, Inc
      • Los Angeles, California, United States, 90024
        • University of California Los Angeles
      • Vallejo, California, United States, 94589
        • Kaiser Permanente
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente - Walnut Creek
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Eastern Connecticut Hematology and Oncology Associates
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Lynn Cancer Institute - West
      • Deerfield Beach, Florida, United States, 33442
        • University of Miami School of Medicine - Sylvester at Deerfield
      • St. Petersburg, Florida, United States, 33705
        • SCRI Florida Cancer Specialists North
    • Georgia
      • Thomasville, Georgia, United States, 31792
        • Lewis Hall Singletary Oncology Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Peoria, Illinois, United States, 61615
        • Illinois Cancer Care
    • Kentucky
      • Louisville, Kentucky, United States, 40402
        • Norton Cancer Institute
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Cancer Institute
    • New Jersey
      • Florham Park, New Jersey, United States, 07932
        • Hematology Oncology Associates of Northern New Jersey
      • Livingston, New Jersey, United States, 07039
        • Saint Barnabas Medical Center
      • Paramus, New Jersey, United States, 07652
        • Valley Hospital
      • Summit, New Jersey, United States, 07901
        • Overlook Medical Center
    • New York
      • Lake Success, New York, United States, 11042
        • Clinical Research Alliance
      • New York, New York, United States, 10065
        • Weill Cornell Medical College
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Presbyterian Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care - SCRI
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • University Oncology Associates
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist Cancer Center
    • Virginia
      • Bristol, Virginia, United States, 24201
        • Wellmont Medical Associates
      • Fredericksburg, Virginia, United States, 22408
        • Hematology Oncology Associates of Fredericksburg, Inc.
    • Washington
      • Auburn, Washington, United States, 98002-4117
        • MultiCare Regional Cancer Center - Auburn
      • Everett, Washington, United States, 98201
        • Providence Everett Med Ctr
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atezolizumab
Enrollment 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.
Drug: Atezolizumab
Participants will receive atezolizumab (1200 mg IV) Q3W for 16 cycles (cycle length=21 days).
Other Names:
  • MPDL3280A; TECENTRIQ
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.
Active Comparator: Best Supportive Care
Enrollment 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Free Survival (DFS) in Intent-to-treat (ITT) Population
Time Frame: Up to 95 months
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.
Up to 95 months
DFS in All Randomized Stage II-IIIA Population
Time Frame: Up to 95 months
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.
Up to 95 months
DFS in the Programmed Death-ligand 1 (PD-L1) SP263 ≥ 1% Tumor Cell (TC) Subpopulation Within the Stage II-IIIA Population
Time Frame: Up to 95 months
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.
Up to 95 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free Rate at Year 3 in ITT Population
Time Frame: Year 3
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.
Year 3
Disease-free Rate at Year 3 in All Randomized Stage II-IIIA Population
Time Frame: Year 3
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.
Year 3
Disease-free Rate at Year 3 in PD-L1 (SP263 ≥ 1% TC) Subpopulation Within the Stage II-IIIA Population
Time Frame: Year 3
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.
Year 3
Disease-free Rate at Year 5 in ITT Population
Time Frame: Year 5
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.
Year 5
Disease-free Rate at Year 5 in All Randomized Stage II-IIIA Population
Time Frame: Year 5
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.
Year 5
Disease-free Rate at Year 5 in PD-L1 (SP263 ≥ 1% TC) Subpopulation Within the Stage II-IIIA Population
Time Frame: Year 5
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.
Year 5
DFS in the PD-L1 (SP263 ≥ 50% TC) Subpopulation Within the Stage II-IIIA Population
Time Frame: Up to 95 months
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.
Up to 95 months
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Time Frame: 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)
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.
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)
Maximum Plasma Concentration (Cmax) of Atezolizumab
Time Frame: 30 min post-infusion on Day 1 of Cycle 1 (Cycle length = 21 days)
30 min post-infusion on Day 1 of Cycle 1 (Cycle length = 21 days)
Minimum Serum Concentration (Cmin) at Steady-State Within a Dosing Interval of Atezolizumab
Time Frame: 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)
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)
Overall Survival (OS) in the ITT Population
Time Frame: Baseline up to death from any cause (up to approximately 126 months)
OS was defined as the time from randomization to death from any cause.
Baseline up to death from any cause (up to approximately 126 months)
Percentage of Participants With Adverse Events (AEs)
Time Frame: Up to 12 years
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.
Up to 12 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2015

Primary Completion (Actual)

January 26, 2024

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

June 4, 2015

First Submitted That Met QC Criteria

June 26, 2015

First Posted (Estimated)

July 1, 2015

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO29527
  • 2014-003205-15 (EudraCT Number)
  • 2023-505981-26-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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