A Study of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) - Lung Cancer Mutation Consortium (LCMC3)
Trial Status: Closed to Accrual
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.
Inclusion Criteria
- 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
Exclusion Criteria
- 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
California
Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Colorado
Aurora
University of Colorado Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Robert Charles Doebele
Phone: 720-848-0650
Email:
robert.doebele@ucdenver.edu
Connecticut
New Haven
Yale University
Status: CLOSED_TO_ACCRUAL
Florida
Tampa
Moffitt Cancer Center
Status: CLOSED_TO_ACCRUAL
Georgia
Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Emory University Hospital Midtown
Status: ACTIVE
Massachusetts
Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE
Massachusetts General Hospital Cancer Center
Status: ACTIVE
Michigan
Detroit
Wayne State University / Karmanos Cancer Institute
Status: CLOSED_TO_ACCRUAL
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: CLOSED_TO_ACCRUAL
New Hampshire
Lebanon
Dartmouth Hitchcock Medical Center
Status: ACTIVE
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: CLOSED_TO_ACCRUAL
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Jamie Erin Chaft
Phone: 646-888-4545
Email:
chaftj@mskcc.org
Ohio
Cleveland
Case Comprehensive Cancer Center
Status: IN_REVIEW
Columbus
Ohio State University Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE
Texas
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: COMPLETED
Trial Phase Phase II
Trial Type Treatment
Lead Organization
Genentech Inc.
- Primary ID ML39236
- Secondary IDs NCI-2016-01591, s16-02095
- Clinicaltrials.gov ID NCT02927301