A Study of Atezolizumab Compared With Docetaxel in Non-Small Cell Lung Cancer (NSCLC) After Failure With Platinum-Containing Chemotherapy

Last updated: January 9, 2023
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT02813785
YO29232
  • Ages > 18
  • All Genders

Study Summary

This Phase III, multicenter, open-label, randomized, controlled study is designed to evaluate the efficacy and safety of the anti-programmed death-ligand 1 (PD-L1) antibody atezolizumab compared with docetaxel in participants with locally advanced or metastatic NSCLC who have progressed during or following a platinum-containing regimen. Treatment may continue until disease progression, loss of clinical benefit, or unacceptable toxicity.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically documented, locally advanced or metastatic NSCLC
  • Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens available or atleast 12 unstained, freshly cut serial sections with associated pathology report thatare evaluable for PD-L1 expression and epidermal growth factor receptor (EGFR)mutation status prior to enrollment, except for known sensitizing EGFR mutations inwhich case 10 unstained slides are required and there is no need for central testingof EGFR mutation status
  • Disease progression during or following treatment with a prior platinum-containingregimen for locally advanced, unresectable, inoperable, or metastatic NSCLC, ordisease recurrence within 6 months of treatment with a platinum-based adjuvant and/orneoadjuvant regimen or combined modality with curative intent
  • Measurable disease per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy greater than or equal to (>/=) 12 weeks
  • Adequate hematologic and end organ function
  • Agreement to remain abstinent or use contraceptive methods among women of childbearingpotential or male partners of women of childbearing potential
  • Recovery from all acute toxicities from previous therapy

Exclusion

Exclusion Criteria:

  • Active or untreated central nervous system (CNS) metastases
  • Spinal cord compression not definitively treated or not clinically stable
  • Leptomeningeal disease
  • Uncontrolled pleural or pericardial effusions or ascites requiring recurrent drainage
  • Uncontrolled tumor-related pain
  • Uncontrolled hypercalcemia
  • Malignancies other than NSCLC within 5 years prior to randomization, except for thosecuratively treated with negligible risk of metastasis or death
  • Pregnant or lactating women
  • Significant cardiovascular, pulmonary, or autoimmune disease
  • Severe infection or major surgery within 4 weeks, or antibiotic treatment within 2weeks prior to randomization
  • Prior treatment with or hypersensitivity to study drug(s) or related compounds
  • Inability to discontinue strong cytochrome P450 (CYP) 3A4 inhibitors
  • Prior allogeneic bone marrow or solid organ transplant
  • Known PD-L1-negative expression status
  • Positive human immunodeficiency virus (HIV) or active hepatitis B or C
  • Receipt of a live attenuated vaccine within 4 weeks prior to randomization
  • Treatment with systemic immunomodulators within 4 weeks or five half-lives (whicheveris shorter) prior to randomization
  • Treatment with systemic corticosteroids within 2 weeks prior to randomization

Study Design

Total Participants: 565
Study Start date:
July 01, 2016
Estimated Completion Date:
December 27, 2022

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, 100142
    China

    Site Not Available

  • Beijing Chest Hospital; Oncology Department

    Beijing, 101149
    China

    Site Not Available

  • Cancer Hospital Chinese Academy of Medical Sciences.

    Beijing, 100021
    China

    Site Not Available

  • Affiliated Hospital of Bengbu Medical College

    Bengbu, 233004
    China

    Site Not Available

  • Jilin Cancer Hospital

    Changchun, 132013
    China

    Site Not Available

  • the First Hospital of Jilin University

    Changchun, 130021
    China

    Site Not Available

  • Changzhou First People's Hospital

    Changzhou, 213003
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu, 610041
    China

    Site Not Available

  • Third Affiliated Hospital of Third Military Medical University

    ChongQing, 400042
    China

    Site Not Available

  • Second Affiliated Hospital of Third Military Medical University

    Chongqing, 400030
    China

    Site Not Available

  • Guangdong General Hospital

    Guangzhou, 510080
    China

    Site Not Available

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120
    China

    Site Not Available

  • Sun Yet-sen University Cancer Center

    Guangzhou City, 510663
    China

    Site Not Available

  • The First Affiliated Hospital of College of Medicine, Zhejiang University

    Hangzhou, 310003
    China

    Site Not Available

  • Sir Run Run Shaw Hospital

    Hangzhou City, 310018
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin, 150081
    China

    Site Not Available

  • Jiangsu Cancer Hospital

    Nanjing, 210009
    China

    Site Not Available

  • Jiangsu Cancer Hospital

    Nanjing City, 211100
    China

    Site Not Available

  • The Affiliated Hospital of Medical College Qingdao University

    Qingdao, 266003
    China

    Site Not Available

  • Shanghai chest hospital

    Shanghai, 200030
    China

    Site Not Available

  • Zhongshan Hospital Fudan University

    Shanghai, 200032
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai City, 200120
    China

    Site Not Available

  • Liaoning cancer Hospital & Institute

    Shenyang, 110042
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, 300052
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin (天津), 300052
    China

    Site Not Available

  • The First Affiliated Hospital of Xian Jiao Tong University

    Xi'an City, 710061
    China

    Site Not Available

  • empty

    Xian,
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Zhejiang, 310022
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, 450008
    China

    Site Not Available

  • Kyungpook National University Medical Center

    Daegu, 41404
    Korea, Republic of

    Site Not Available

  • Chungnam National University Hospital

    Daejeon, 35015
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128
    Korea, Republic of

    Site Not Available

  • Korea University Guro Hospital

    Seoul, 08308
    Korea, Republic of

    Site Not Available

  • Hospital Sultan Ismail; Oncology

    Johor Bahru, 81100
    Malaysia

    Site Not Available

  • Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi

    Kuala Lumpur, 50586
    Malaysia

    Site Not Available

  • Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care

    Sarawak, 93586
    Malaysia

    Site Not Available

  • National Cancer Centre; Medical Oncology

    Singapore, 169610
    Singapore

    Site Not Available

  • Chulalongkorn Hospital; Medical Oncology

    Bangkok, 10330
    Thailand

    Site Not Available

  • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

    Bangkok, 10700
    Thailand

    Site Not Available

  • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

    Bangkok, 10400
    Thailand

    Site Not Available

  • CHIANG MAI UNI HOSPITAL; FACULTY OF MEDICINE; Medical Oncology unit

    Chiang Mai, 50200
    Thailand

    Site Not Available

  • Khon Kaen University

    Khon Kaen, 40002
    Thailand

    Site Not Available

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