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SCCA Clinical Studies: Lung Cancer

MPDL3280A for PD-L1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (20131756)
A Phase II, Multicenter, Single-Arm study of MPDL3280A in Patients with PD-L1-Positive Locally Advanced or Metastatic Non-Small Cell lung Cancer
Status Conditions Phase Study ID
Recruiting Non-Small Cell Lung Cancer Phase II 20131756
NCT02031458
Summary

This multicenter, single- arm study will evaluate the efficacy and safety of MPD L3280A 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 for a maximum of 16 cycles (or 12 months, whichever occurs first) in the a bsence of unacceptable toxicity or symptomatic deterioration attributed to disea se progression. Patients who complete the initial treatment stage may be eligibl e fro MPDL3280A re-treatment upon subsequent disease progression during the foll ow-up period without intervening systemic anti-cancer therapy.


Investigator
Laura Chow
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • 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 performed by a central laboratory
  • Measurable disease, as defined by RECIST v1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusions (conditions that would prevent participation in this study)
  • 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

Other exclusion criteria may apply.

Last Updated
July 07, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.