Summary

for people ages 18 years and up (full criteria)
at UC Davis
study started
estimated completion:

Description

Summary

This is a randomized, double-blinded study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in patients with resectable Stage II, IIIA, or select IIIB non−small cell lung cancer (NSCLC) followed by open-label adjuvant atezolizumab or best supportive care and monitoring.

Official Title

A Phase III, Double-Blinded, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Neoadjuvant Treatment With Atezolizumab or Placebo in Combination With Platinum-Based Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non−Small Cell Lung Cancer

Keywords

Non-Small-Cell Lung Carcinoma, Non-Small-Cell Lung Paclitaxel Atezolizumab Albumin-Bound Paclitaxel Cisplatin Carboplatin Pemetrexed Antibodies Antibodies, Monoclonal Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Nab-paclitaxel

Eligibility

You can join if…

Open to people ages 18 years and up

  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Histologically or cytologically confirmed, resectable Stage II, IIIA, or Select IIIB(T3N2 only) NSCLC of squamous or non-squamous histology. Staging should be based on the 8th edition of the AJCC/UICC staging system
  • Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent
  • Adequate pulmonary and cardiac function to undergo surgical resection
  • Measurable disease as defined by RECIST v1.1
  • Adequate hematologic and end organ function
  • Negative HIV test at screening
  • Negative for active HBV and HCV at screening

You CAN'T join if...

  • Any prior therapy for lung cancer
  • Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated expected curative outcome
  • Non-squamous NSCLC histology with activating ALK and EGFR mutation
  • Pregnant or lactating women
  • History of autoimmune disease
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or evidence of active of active pneumonitis on screening chest Computed Tomography (CT) scan
  • Prior treatment with cluster of differentiation 137 (CD137) agonist or immune checkpoint blockade therapies, anti-programmed-death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody
  • Severe infection within 4 weeks prior to randomization
  • Significant history of cardiovascular disease

Locations

  • UC Davis Cancer Center; Oncology accepting new patients
    Sacramento California 95817 United States
  • Scripps Clinic accepting new patients
    San Diego California 92037 United States
  • USC Norris Cancer Center; USC Oncology Hematology Newport Beach accepting new patients
    Newport Beach California 92663 United States
  • The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange accepting new patients
    Orange California 92868 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT03456063
Phase
Phase 3
Study Type
Interventional
Last Updated