Clinical Trials

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SCCA Clinical Studies: Lung Cancer

MPDL3280A for PD-L1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (UW13020)
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
Closed Non-Small Cell Lung Cancer Phase II UW13020
NCT01846416
Summary

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 (NSCLC). Patients will receive an intravenous dose of 1200 mg MPDL3280A on Day 1 of 21-day cycles for a maximum of 16 cycles.


Investigator
Laura Q.M. Chow, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Stage IIIB (not eligible for definitive chemoradiotherapy), Stage IV, or recurrent non-small cell lung cancer (NSCLC)
  • PD-L1-positive status as determined by an IHC assay performed by a central laboratory
  • ECOG Performance Status of 0 or 1
  • Life expectancy >= 12 weeks
  • Measurable disease, as defined by RECIST v1.1
  • Adequate hematologic and end organ function
Exclusions (conditions that would prevent participation in this study)
  • Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exceptions are allowed:
  • Hormone-replacement therapy or oral contraceptives Tyrosine kinase inhibitors approved for treatment of NSCLC discontinued > 7 days prior to Cycle 1 Day 1
  • Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
  • Known CNS disease, including treated brain metastases: Cohorts 1 and 2
  • Patients with a history of treated asymptomatic brain metastases are allowed in Cohort 3
  • Leptomeningeal disease
  • Uncontrolled tumor-related pain
  • Uncontrolled hypercalcemia
Last Updated
September 12, 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.