Lung Cancer Clinical Trial
A Study of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) – Lung Cancer Mutation Consortium (LCMC3)
Summary
This study was designed to evaluate the safety and efficacy of neoadjuvant and adjuvant atezolizumab in participants with resectable Non-Small Cell Lung Cancer (NSCLC). Neoadjuvant therapy consisted of two 21-day cycles with atezolizumab. Following surgery, adjuvant therapy consisted of up to 12 months of atezolizumab in participants who demonstrate clinical benefit with neoadjuvant therapy. All participants who undergo surgery entered a surveillance period, which consisted of standardized blood sample collection and Chest CT Scans, for up to 2 years. All participants were monitored for disease recurrence and survival for up to 3 years after last dose of study drug.
Eligibility Criteria
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
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There are 20 Locations for this study
Duarte California, 91010, United States
Santa Monica California, 90404, United States
Aurora Colorado, 80045, United States
New Haven Connecticut, 06520, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30308, United States
Boston Massachusetts, 02115, United States
Danvers Massachusetts, 01923, United States
Detroit Michigan, 48201, United States
Saint Louis Missouri, 63110, United States
Lebanon New Hampshire, 03756, United States
Middletown New Jersey, 07748, United States
Montvale New Jersey, 07645, United States
Commack New York, 11725, United States
Harrison New York, 10604, United States
New York New York, 10021, United States
New York New York, 10036, United States
New York New York, 10065, United States
New York New York, 10065, United States
Uniondale New York, 11553, United States
Columbus Ohio, 43210, United States
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