A Study of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) - Lung Cancer Mutation Consortium (LCMC3)



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:April 20, 2017
End Date:October 31, 2024
Contact:Reference Study ID Number: ML39236 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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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

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
We found this trial at
22
sites
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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Duarte, CA
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Atlanta, GA
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Aurora, Colorado 80045
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Boston, MA
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Columbus, OH
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650 Commack Rd
Commack, New York 11725
(631) 623-4000
Memorial Sloan-Kettering Cancer Center at Commack Memorial Sloan Kettering Cancer Center - the world's oldest...
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Commack, NY
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102-104 Endicott Street
Danvers, Massachusetts 01923
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500 Westchester Avenue
Harrison, New York 10604
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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Middletown, New Jersey 07748
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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New York, New York 10021
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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1275 York Avenue
New York, New York 10065
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5115 Centre Avenue
Pittsburgh, Pennsylvania 15232
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1000 North Village Avenue
Rockville Centre, New York 11570
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660 South Euclid Avenue
Saint Louis, Missouri 63110
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Santa Monica, California
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Tampa, Florida 33612
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