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A Study of Atezolizumab in Participants With Programmed Death - Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT02031458

Description:

This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in participants with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Participants will receive Atezolizumab 1200 milligrams (mg) intravenously every 3 weeks as long as participants are experiencing clinical benefit as assessed by the investigator, that is , in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

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

Completed

Phase:

Phase 2

Trial Eligibility

Document

A Phase 2 Study of <span class="go-doc-concept go-doc-intervention">MPDL3280A</span> (an Engineered Anti-PDL1 <span class="go-doc-concept go-doc-intervention">Antibody</span>) in Patients With PD-L1 Positive Locally Advanced or Metastatic Non-Small Cell <span class="go-doc-concept go-doc-disease">Lung Cancer</span> - "BIRCH"

Title

  • Brief Title: A Phase 2 Study of MPDL3280A (an Engineered Anti-PDL1 Antibody) in Patients With PD-L1 Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer - "BIRCH"
  • Official Title: A PHASE II, MULTICENTER, SINGLE-ARM STUDY OF MPDL3280A IN PATIENTS WITH PD-L1-POSITIVE LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER
  • Clinical Trial IDs

    NCT ID: NCT02031458

    ORG ID: GO28754

    NCI ID: 2013-003330-32

    Trial Conditions

    Non-Small Cell Lung Cancer

    Trial Interventions

    Drug Synonyms Arms
    MPDL3280A MPDL3280A

    Trial Purpose

    This multicenter, single-arm study will evaluate the efficacy and safety of MPDL3280A in
    patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer.
    Patients will receive MPDL3280A 1200 mg intravenously every 3 weeks as long as patients are
    experiencing clinical benefit as assessed by the investigator, i.e., in the absence of
    unacceptable toxicity or symptomatic deterioation attributed to disease progression.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    MPDL3280A Experimental MPDL3280A

    Eligibility Criteria

    Inclusion Criteria:

    - Adult patients, >/= 18 years of age

    - Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) non-small cell
    lung cancer (NSCLC)

    - Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens

    - PD-L1-positive tumor status as determined by an IHC assay based on PD-L1 expression
    on tumor infiltrating immune cells and/or tumor cells performed by a central
    laboratory

    - Measurable disease, as defined by RECIST v1.1

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

    Exclusion Criteria:

    - Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within
    3 weeks prior to initiation of study treatment; the following exception are allowed:

    Hormone-replacement therapy or oral contraceptives TKIs approved for treatment of NSLC
    discontinued > 7 days prior to Cycle 1, Day 1

    - Central nervous system (CNS) disease, including treated brain metastases.

    - Malignancies other than NSCLC within 5 years prior to randomization, with the
    exception of those with negligible risk of metastases or death and treated with
    expected curative outcome

    - History of autoimmune disease

    - History of idiopathic pulmonary fibrosis (including pneumonia), drug-induced
    pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening CT
    scan. History of radiation pneumonitis in the radiation field (fibrosis) id
    permitted.

    - Active hepatitis B or hepatitis C

    - HIV positive

    - Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic
    antibody or pathway-targeting agents

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Objective response rate (ORR), Independent review facility (IRF)-assessed according to RECIST v1.1

    ORR, Investigator-assessed according to modified RECIST

    Secondary Outcome Measures

    Duration of response

    Progression-free survival

    Overall survival

    Safety: Incidence of adverse events

    Pharmacokinetics: Maximum serum concentration (Cmax)

    Pharmacokinetics: Minimum serum concentration under steady-state conditions within a dosing interval

    Trial Keywords