Summary

for people ages 18 years and up (full criteria)
at Sacramento, California and other locations
study started
estimated completion

Description

Summary

This is a randomized, double-blinded study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity 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 Gemcitabine Paclitaxel Albumin-Bound Paclitaxel Cisplatin Carboplatin Pemetrexed Atezolizumab 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
  • Adequate tissue for PD-L1 IHC assessment

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
  • Gene Upshaw Memorial Tahoe Forest Cancer Center withdrawn
    Truckee California 96161 United States

Details

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