Eine Studie zu Atezolizumab bei Teilnehmenden mit PD-L1-positivem, lokal fortgeschrittenem oder metastatischem nicht-kleinzelligem Lungenkarzinom (PD-L1: programmierter Zelltod-Ligand 1)

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

  • Krebs
  • Lungenkrebs
  • Nicht-kleinzelliges Lungenkarzinom
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:

Abgeschlossen

Diese Studie läuft in
Städte
  • Essen
  • Großhansdorf
  • Nürnberg
  • Oldenburg
  • Villingen-Schwenningen
Studien-ID:

NCT02031458 2013-003330-32 GO28754

      Studienzentren finden

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden für Laien bearbeitet.

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden nicht geändert.

      Results Disclaimer

      Studienzusammenfassung

      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.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT02031458, GO28754, 2013-003330-32 Studien-ID
      Atezolizumab Treatments
      Non-Small Cell Lung Cancer Condition
      Official Title

      A Phase II, Multicenter, Single-Arm Study OF Atezolizumab In Patients With PD-L1-Positive Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

      Einschlusskriterien

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Adult participants greater than or equal to 18 years of age
      • Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) NSCLC
      • Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
      • PD-L1-positive tumor status as determined by an immunohistochemistry (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 version 1.1
      • 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 tyrosine-kinase inhibitors (TKIs) approved for treatment of NSCLC 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
      • Human Immunodeficiency virus (HIV) positive
      • Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents

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