A Phase III Study of MPDL3280A (Anti-PD-L1) in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-paclitaxel Compared With Carboplatin + Nab-paclitaxel in Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

Investigator:  Brian L. Erickson, MD

Status: Recruiting

Phase: 3

Sponsor: Hoffmann-La Roche

Contact: Jennifer Montgomery, 541-706-6590 or jrobinson@bmctotalcare.com

Location: Bend, Oregon (Central Oregon)

Purpose: This randomized, open-label study will evaluate the safety and efficacy of Atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naïve patients with Stage IV squamous non-small cell lung cancer (NSCLC).

Inclusion Criteria:

  • 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Histologically or cytologically confirmed, treatment-naïve Stage IV squamous NSCLC
  • Previously obtained archival tumor tissue or tissue obtained from biopsy at screening
  • Measurable disease as defined by RECIST v1.1
  • Adequate hematologic and end organ function

Exclusion Criteria:

  • Active or untreated central nervous system (CNS) metastasis
  • Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
  • Pregnant or lactating women
  • History of autoimmune disease
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest Computed Tomography (CT) scan, History of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • Positive test for Human Immunodeficiency Virus (HIV)
  • Active hepatitis B or hepatitis C
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti PD-1, and anti-PD-L1 therapeutic antibody
  • Severe infection within 4 weeks prior to randomization
  • Significant history of cardiovascular disease

See this trial at ClinicalTrials.gov

For general inquiries, please contact the BMC Research Department at research@bmctotalcare.com or 877-692-8338.

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