A Study of Atezolizumab Compared With Chemotherapy in Treatment Naïve Participants With Locally Advanced or Recurrent or Metastatic Non-Small Cell Lung Cancer Who Are Deemed Unsuitable For Platinum-Containing Therapy

  • Cancer
  • Lung Cancer
  • Non‑Small Cell Lung Cancer (NSCLC)
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Completed

This study runs in
Cities
  • ABD
  • Almaty
  • Barakaldo
  • bei-jing-shi
  • Bellinzona
  • Berlin
  • Birmingham
  • chang-sha-shi
  • Charleroi
  • Chihuahua
  • Ciudad de México
  • Cluj-Napoca
  • Coimbra
  • dooradoyle
  • Dublin
  • Florești
  • Gauting
  • Glasgow
  • Großhansdorf
  • Gujarat
  • Halle (Saale)
  • hang-zhou-shi
  • he-fei-shi
  • Hyderabad
  • Hà Nội
  • Hồ Chí Minh
  • Immenhausen
  • Jette
  • Kolkata
  • L'Hospitalet de Llobregat
  • la-calera
  • lapkaman
  • Leuven
  • London
  • Luxembourg
  • Madrid
  • Manchester
  • Mar del Plata
  • Marburg
  • Medellín
  • Moncton
  • Montería
  • Montréal
  • Monza
  • Mumbai
  • Murcia
  • Málaga
  • Nashik
  • New Delhi
  • Nitra
  • Odense
  • olomouc-9
  • Ottawa
  • Otwock
  • Pereira
  • Pleven
  • Plovdiv
  • Porto
  • Pune
  • Ravenna
  • Regensburg
  • Rio Grande do Sul
  • Roma
  • San Luis Potosí
  • Santiago de Compostela
  • Sevilla
  • Shanghai
  • São Paulo
  • Thun
  • tian-jin-shi
  • Timișoara
  • Toronto
  • Trnavský kraj
  • Truro
  • Tübingen
  • València
  • Vancouver
  • Viedma
  • Warsaw
  • Winterthur
  • Wirral
  • Wuhan
  • York
Trial Identifier:

NCT03191786 2015-004105-16 MO29872

  • Almaty Oncology Center

    050054AlmatyKazakhstan
  • Anhui Provincial Hospital

    17 Lu Jiang Lu230061he-fei-shiChina
  • Asklepios Klinik Gauting; Onkologisches Studienzentrum

    2 Robert-Koch-Allee82131GautingGermany
  • Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1

    87 Circonvallazione Gianicolense00152RomaItaly
  • Azienda Ospedaliera San Gerardo di Monza

    33 Via G. B. Pergolesi20900MonzaItaly
  • Bach Mai Hospital

    78 Giải PhóngHà NộiVietnam
  • BCCA-Vancouver Cancer Centre

    V5Z 4E6VancouverCanada
  • Beijing Cancer Hospital

    52 Fu Cheng Lu100142bei-jing-shiChina
  • Birmingham Heartlands Hospital

    B9 5SSBirminghamUnited Kingdom
  • Centre Hospitalier de Luxembourg

    4 Rue Nicolas Ernest Barblé1210LuxembourgLuxembourg
  • Centro Estatal de Cancerologia de Chihuahua; ONCOLOGY

    3700 Ejército Mexicano31000ChihuahuaMexico
  • Centrul de Radioterapie AMETHYST

    407280FloreștiRomania
  • Cho Ray Hospital

    201B Đ. Nguyễn Chí Thanh700000Hồ Chí MinhVietnam
  • Christie Hospital Nhs Trust; Medical Oncology

    M20 4BXManchesterUnited Kingdom
  • CHUC - Unidade de Pneumologia Oncológica; Hospital de Dia de Oncologia Edificio Sao Jeronimo

    3030 Praceta Carlos da Mota Pinto3030CoimbraPortugal
  • Clatterbridge Cancer Centre

    CH63 4JYWirralUnited Kingdom
  • Clinica Viedma S.A.

    ViedmaArgentina
  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

    s/n Rúa da Choupana15706Santiago de CompostelaSpain
  • Complex Oncology Center (COC)-Plovidiv

    4000PlovdivBulgaria
  • Deenanath Mangeshkar Hospital & Research Centre

    411004PuneIndia
  • Evang. Lungenklinik Berlin Klinik für Pneumologie

    27 Lindenberger Weg13125BerlinGermany
  • Fachklinik für Lungenerkrankungen

    3 Robert-Koch-Straße34376ImmenhausenGermany
  • Fakultna nemocnica Trnava

    11 Andreja Žarnova917 02Trnavský krajSlovakia
  • Fakultni nemocnice Olomouc; Pneumologicka klinika

    248/7 Zdravotníků779 00olomouc-9Czechia
  • Fundacion Cardioinfantil

    110131la-caleraColombia
  • Fundación CENIT para la Investigación en Neurociencias

    2222 JuncalC1125ABDArgentina
  • Fundación Centro de Investigación Clínica CIC

    050021MedellínColombia
  • Grand Hôpital de Charleroi Notre Dame

    3 Grand'Rue6000CharleroiBelgium
  • Grant Medical Foundation, Ruby Hall Clinic

    No. 40 Sasoon Rd411001PuneIndia
  • HCG Manavata Cancer Centre

    422002NashikIndia
  • Health Pharma Professional Research

    662 Av. Insurgentes Sur03100Ciudad de MéxicoMexico
  • HealthCare Global Cancer Centre; Medical Oncology

    380060lapkamanIndia
  • Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

    12 Carrer de Sant Clement46015ValènciaSpain
  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

    S/N Campus de Teatinos29010MálagaSpain
  • Hospital de Cruces; Servicio de Oncologia

    s/n Cruces Plaza48903BarakaldoSpain
  • Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia

    s/n Av. Marqués de Los Vélez30008MurciaSpain
  • Hospital Nossa Senhora da Conceicao

    596 Av. Francisco Trein91350-200Rio Grande do SulBrazil
  • Hospital Privado de Comunidad

    Mar del PlataArgentina
  • Hospital Sao Lucas - PUCRS

    6690 Av. Ipiranga90610-001Rio Grande do SulBrazil
  • Hospital Universitario Clínico San Carlos; Servicio de Oncologia

    28040MadridSpain
  • Hospital Universitario de la Princesa; Servicio de Oncologia

    62 Calle de Diego de León28006MadridSpain
  • Hospital Universitario Virgen Macarena; Servicio de Oncologia

    3 Av. Dr. Fedriani41009SevillaSpain
  • Hu Nan Provincial Cancer Hospital

    410006chang-sha-shiChina
  • Indo-American Cancer Hospital & Research Center

    500034HyderabadIndia
  • Indraprastha Apollo Hospitals

    110076New DelhiIndia
  • Institut Catala d Oncologia Hospital Duran i Reynals

    199 Avinguda de la Granvia de l’Hospitalet08908L'Hospitalet de LlobregatSpain
  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    251 Av. Dr. Arnaldo01246-000São PauloBrazil
  • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala

    34-36 Str. Republicii400015Cluj-NapocaRomania
  • IPO do Porto; Servico de Oncologia Medica

    4200-072PortoPortugal
  • Jewish General Hospital

    3755 Chem. de la Côte-Sainte-CatherineH3T 1E2MontréalCanada
  • Kailash Cancer Hospital and Research Center

    391760GujaratIndia
  • Kantonsspital Winterthur; Medizinische Onkologie

    WinterthurSwitzerland
  • Kazakh Scientific Research Institution Of Oncology and Radiology

    AlmatyKazakhstan
  • Klinikum der Philipps-Universität Marburg

    35MarburgGermany
  • Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute; Department of Rheumatologz

    400053MumbaiIndia
  • Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II

    1 Röntgenstraße06120Halle (Saale)Germany
  • LungenClinic Großhansdorf GmbH; Klinische Forschung

    80 Wöhrendamm22927GroßhansdorfGermany
  • Mater Misericordiae University Hospital - Institute for Cancer Research

    DublinIreland
  • Max Super Speciality Hospital

    2 Press Enclave Marg110017New DelhiIndia
  • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii

    83/91 Reymonta05-400OtwockPoland
  • Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers

    03WarsawPoland
  • New Victoria Hospital

    55 Grange RdG42 9LLGlasgowUnited Kingdom
  • Odense Universitetshospital, Onkologisk Afdeling R

    9 Kløvervænget5000OdenseDenmark
  • Oncocenter Timisoara

    1A Strada Gării300166TimișoaraRomania
  • Oncologico Potosino

    139 La Mora78209San Luis PotosíMexico
  • Oncólogos de Occidente

    660001PereiraColombia
  • Oncomedica S.A.

    72-34 Cra. 6230002MonteríaColombia
  • Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica

    5 Viale Vincenzo Randi48121RavennaItaly
  • Ospedale Regionale di Bellinzona Medizin Onkologie

    10 Via Ospedale6500BellinzonaSwitzerland
  • Ottawa Hospital Research Institute

    1053 Carling AveK1Y 4E9OttawaCanada
  • P.D. Hinduja Nat. Hospital & Med. Research Centre

    8-12 SVS Marg400016MumbaiIndia
  • Princess Margaret Cancer Center

    M5G 2L7TorontoCanada
  • Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology

    110049New DelhiIndia
  • Regional health authority A vitalite health network

    E1C 8X3MonctonCanada
  • Royal Cornwall Hospital; Dept of Clinical Oncology

    2 Penventinnie LnTR1 3LQTruroUnited Kingdom
  • Shanghai Chest Hospital

    ShanghaiChina
  • Specializovana nemocnica sv. Svorada Zobor, n.o.; Oddelenie klinickej onkologie

    388/134 Kláštorská949 01NitraSlovakia
  • Spital STS AG - Spital Thun Medizin Onkologie; MEDIZINISCHE KLINIK

    12 Krankenhausstrasse3600ThunSwitzerland
  • Tata Medical Center; Department of Medical Oncology

    14 MAR(E-W)700160KolkataIndia
  • Tata Memorial Hospital; Dept of Medical Oncology

    400012MumbaiIndia
  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    88号 Jie Fang Lu310009hang-zhou-shiChina
  • Tianjin Cancer Hospital

    300060tian-jin-shiChina
  • Umhat Dr Georgi Stranski; Clinic of Chemotherapy

    5809PlevenBulgaria
  • Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center

    WuhanChina
  • Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie

    11 Franz-Josef-Strauß-Allee93053RegensburgGermany
  • Universitätsklinikum Tübingen; Innere Medizin VIII, Medizinische Onkologie und Pneumologie

    12 Otfried-Müller-Straße72076TübingenGermany
  • University College London Hospitals NHS Foundation Trust - University College Hospital

    235 Euston Rd.NW1 2BULondonUnited Kingdom
  • University Hospital Limerick - Clinical Trials Department

    V94 F858dooradoyleIreland
  • UZ Brussel

    101 Av. du Laerbeek1090JetteBelgium
  • UZ Leuven Gasthuisberg

    49 Herestraat3000LeuvenBelgium
  • YORK DISTRICT HOSPITAL; Haematology/Oncology Department

    YO31 8HEYorkUnited Kingdom
    Show study locations

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

    Results Disclaimer

    Study Summary

    This Phase III, global, multicenter, open-label, randomized, controlled study will evaluate the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 [anti-PD-L1] antibody) compared with a single agent chemotherapy regimen by investigator choice (vinorelbine or gemcitabine) in treatment-naïve participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are deemed unsuitable for any platinum‑doublet chemotherapy due to poor performance status (Eastern Cooperative Oncology Group [ECOG] performance status of 2-3).

    Hoffmann-La Roche Sponsor
    Phase 3 Phase
    NCT03191786, MO29872, 2015-004105-16 Trial Identifier
    Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Vinorelbine, Gemcitabine Treatments
    Non-Small Cell Lung Cancer Condition
    Official Title

    A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab Compared With Chemotherapy in Patients With Treatment Naïve Advanced or Recurrent (Stage IIIb Not Amenable for Multimodality Treatment) or Metastatic (Stage IV) Non-Small Cell Lung Cancer Who Are Deemed Unsuitable for Platinum-Containing Therapy

    Eligibility Criteria

    All Gender
    ≥ 18 Years Age
    No Healthy Volunteers
    Inclusion Criteria
    • Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC as per the American Joint Committee on Cancer (AJCC) 7th edition
    • No sensitizing epidermal growth factor receptor (EGFR) mutation (L858R or exon 19 deletions) or anaplastic lymphoma kinase (ALK) fusion oncogene detected
    • No prior systemic treatment for advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC as per the AJCC 7th edition
    • Life expectancy greater than or equal to (>/=) 8 weeks
    • Deemed unsuitable by the investigator for any platinum-doublet chemotherapy due to poor performance status (ECOG performance status of 2-3). However, participants >= 70 years of age who have an ECOG PS of 0 or 1 may be included due to: a) substantial comorbidities; b) contraindication(s) for any platinum-doublet chemotherapy
    • Representative formalin-fixed paraffin-embedded (FPPE) tumor tissue block obtained during course of disease (archival tissue) or at screening
    • Participants with treated, asymptomatic central nervous system (CNS) metastases are eligible, provided they meet all of the following criteria: Measurable disease outside CNS; Only supratentorial and cerebellar metastases allowed; No ongoing requirement for corticosteroids as therapy for CNS disease; No stereotactic radiation within 7 days or whole-brain radiation within 14 days prior to randomization; No evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study
    • Adequate hematologic and end organ function
    • Female participants of childbearing potential randomized to the atezolizumab treatment arm agree to use protocol defined methods of contraception
    Exclusion Criteria

    Cancer-Specific Exclusion Criteria:

    • Participants younger than 70 years who have an ECOG performance status of 0 or 1
    • Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation of the brain during screening and prior radiographic assessments
    • Uncontrolled tumor-related pain
    • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
    • Uncontrolled or symptomatic hyerpcalcemia (ionized calcium > 1.5 mmol/L or calcium >12 mg/dL or corrected serum calcium >ULN)
    • History of other malignancy within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
    • National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 (v4.0) Grade 3 or higher toxicities due to any prior therapy (example [e.g.], radiotherapy) (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medication
    • Participants who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last chemotherapy, radiotherapy, or chemoradiotherapy

    General Medical Exclusion Criteria:

    • History of autoimmune disease except autoimmune-related hypothyroidism and controlled Type I diabetes mellitus
    • History of idiopathic pulmonary fibrosis (IPF), organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis
    • Known positivity for human immunodeficiency virus (HIV)
    • Known active hepatitis B or hepatitis C
    • Active tuberculosis
    • Severe infections within 4 weeks prior to randomization
    • Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), myocardial infarction within 3 months prior to randomization, unstable arrhythmias, or unstable angina
    • Major surgical procedure other than for diagnosis within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study
    • Prior allogeneic bone marrow transplantation or solid organ transplant
    • Participants with an illness or condition that may interfere with capacity or compliance with the study protocol, as per investigator's judgment
    • Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days prior to randomization

    Exclusion Criteria Related to Atezolizumab:

    • 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
    • Oral or IV antibiotic treatment
    • Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation that such a live attenuated vaccine will be required during the study
    • Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies
    • Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to randomization
    • Treatment with systemic corticosteroids or other immunosuppressive medications
    • Participants not willing to stop treatment with traditional herbal medicines

    Exclusion Criteria Related to Chemotherapy:

    • Known sensitivity and contraindications to the 2 comparative chemotherapy agents (that is [i.e.] vinorelbine, oral or intravenous, and gemcitabine, intravenous)

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