Summary

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

Description

Summary

This study is designed to evaluate the safety and efficacy of neoadjuvant and adjuvant atezolizumab in participants with resectable Non-Small Cell Lung Cancer (NSCLC). Neoadjuvant therapy will consist of two 21-day cycles with atezolizumab. Following surgery, adjuvant therapy will consist of up to 12 months of atezolizumab in participants who demonstrate clinical benefit with neoadjuvant therapy. All participants who undergo surgery will enter a surveillance period, which consists of standardized blood sample collection and Chest CT Scans, for up to 2 years. All participants will be monitored for disease recurrence and survival for up to 3 years after last dose of study drug.

Official Title

A Phase II, Open-Label, Multicenter, Single-Arm Study to Investigate the Efficacy and Safety of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Patients With Stage IB, II, IIIA, or Selected IIIB Resectable and Untreated Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung CancerLung NeoplasmsCarcinoma, Non-Small-Cell LungAntibodiesAntibodies, MonoclonalAtezolizumabAtezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody

Eligibility

You can join if…

Open to people ages 18 years and up

  • Pathologically documented Stage IB, II, IIIA, or selected IIIB, including T3N2 or T4 (by size criteria, not by mediastinal invasion) NSCLC
  • Adequate pulmonary and cardiac function
  • Available biopsy of primary tumor with adequate samples
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

You CAN'T join if...

  • NSCLC that is clinically T4 by virtue of mediastinal organ invasion or Stage IIIB by virtue of N3 disease
  • Any prior therapy for lung cancer within 3 years.
  • Prior treatment with anti-PD-1 or PD-L1 therapies
  • History or risk of autoimmune disease

Locations

  • UCLA Cancer Center accepting new patients
    Santa MonicaCalifornia90404United States
  • Cedars Sinai Medical Center withdrawn
    Los AngelesCalifornia90048United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Genentech, Inc.
ID
NCT02927301
Phase
Phase 2
Study Type
Interventional
Last Updated