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A Study of Atezolizumab Compared With Gemcitabine Plus (+) Cisplatin or Carboplatin for PD-L1-Selected Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower111)

NCT02409355

Description:

This randomized, open-label study was designed to evaluate and compare the safety and efficacy of atezolizumab with gemcitabine + cisplatin or carboplatin in PD-L1 selected participants with chemotherapy-naive, Stage IV squamous NSCLC. The study was closed due to low patient enrollment and the Sponsor's decision to include patients with squamous NSCLC into the GO29431 study, NCT02409342. Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 3

Trial Eligibility

Document

A Study of Atezolizumab (MPDL3280A) Compared With Gemcitabine + Cisplatin or Carboplatin in Patients With Stage IV Squamous Non-Small Cell Lung Cancer [IMpower111]

Title

  • Brief Title: A Study of Atezolizumab (MPDL3280A) Compared With Gemcitabine + Cisplatin or Carboplatin in Patients With Stage IV Squamous Non-Small Cell Lung Cancer [IMpower111]
  • Official Title: A Phase III, Open-Label, Randomized Study of MPDL3280A (Anti-PD-L1 Antibody) Compared With Gemcitabine + Cisplatin or Carboplatin for PD-L1-Selected, Chemotherapy Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer
  • Clinical Trial IDs

    NCT ID: NCT02409355

    ORG ID: GO29432

    Trial Conditions

    Non-Squamous Non-Small Cell Lung Cancer

    Trial Interventions

    Drug Synonyms Arms
    Atezolizumab (MPDL3280A) Atezolizumab (MPDL3280A)
    Carboplatin Gemcitabine + (Cisplatin or Carboplatin)
    Cisplatin Gemcitabine + (Cisplatin or Carboplatin)
    Gemcitabine Gemcitabine + (Cisplatin or Carboplatin)

    Trial Purpose

    This randomized, open-label study is designed to evaluate and compare the safety and
    efficacy of Atezolizumab (MPDL3280A) compared with treatment with gemcitabine + cisplatin or
    carboplatin in patients with chemotherapy-naive, Stage IV squamous non-small cell lung
    cancer (NSCLC).

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Atezolizumab (MPDL3280A) Experimental Patients assigned to receive MPDL3280A single-agent chemotherapy Atezolizumab (MPDL3280A)
    Gemcitabine + (Cisplatin or Carboplatin) Active Comparator Patients assigned to a dual regimen of gemcitabine plus cisplatin or gemcitabine plus carboplatin Carboplatin, Cisplatin, Gemcitabine

    Eligibility Criteria

    Inclusion Criteria:

    - Patients 18 years of age or older

    - Histologically or cytologically confirmed Stage IV NSCLC

    - Tumor PD-L1 expression as determined by immunohistochemistry (IHC) assay of archival
    tumor tissue or tissue obtained at screening

    - No prior treatment for Stage IV NSCLC

    - Measurable disease as defined by Response Evaluation Criteria in Solid Tumors version
    1.1 (RECIST v1.1)

    - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

    - Adequate hematologic and end-organ function

    Exclusion Criteria:

    - Active or untreated central nervous system (CNS) metastases

    - Untreated or inadequately treated spinal cord compression

    - Leptomeningeal disease

    - Uncontrolled pleural effusion, pericardial effusion, or ascites

    - Uncontrolled tumor-related pain

    - Uncontrolled hypercalcemia

    - Any other malignancies within 5 years except those with negligible risk of metastasis
    or death

    - Pregnant or lactating women

    - Known hypersensitivity to any component of MPDL3280A or other study medication

    - History of autoimmune disease except controlled, treated hypothyroidism or type I
    diabetes

    - Prior allogeneic bone marrow or solid organ transplantation

    - Positive HIV test

    - Active hepatitis B or C

    - Active tuberculosis

    - Significant cardiovascular disease

    - Severe infection or major surgery within 4 weeks prior to randomization

    - Use of any approved anti-cancer therapy within 3 weeks prior to treatment

    - Use of an investigational agent or participation in another clinical trial within 4
    weeks prior to randomization

    - Exposure to oral or intravenous (IV) antibiotics within 2 weeks or live attenuated
    vaccines within 4 weeks prior to randomization

    - Prior treatment with CD137 agonists or immune checkpoint blockade therapies,
    anti-PD-1, and anti-PD-L1 therapeutic antibodies

    - Treatment with immunostimulatory agents within 4 weeks or immunosuppressive agents
    within 2 weeks prior to randomization

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Progression-free survival (PFS) as determined by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

    Secondary Outcome Measures

    Safety: Incidence of adverse events

    Objective response rate (ORR) as determined by the investigator using RECIST v1.1 criteria

    Overall survival (OS)

    Time to deterioration (TTD) in patient-reported lung cancer symptoms

    PFS as determined by an independent review facility (IRF) using RECIST v1.1

    Duration of response (DOR) as determined by the investigator using RECIST v1.1

    Time in response (TIR) as determined by the investigator using RECIST v1.1

    OS at 1 and 2 years

    Change from baseline in patient-reported lung cancer symptoms

    Pharmacokinetics: Minimum observed serum concentration (Cmin) of MPDL3280A

    Pharmacokinetics: Maximum observed serum concentration (Cmax) of MPDL3280A

    Trial Keywords