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.

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 Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung Antibodies Antibodies, Monoclonal Atezolizumab Atezolizumab (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
  • Prior treatment with anti-PD-1 or PD-L1 therapies
  • History or risk of autoimmune disease

Locations

  • UCLA Cancer Center accepting new patients
    Santa Monica California 90404 United States
  • Cedars Sinai Medical Center withdrawn
    Los Angeles California 90048 United States

Details

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