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

Completed · Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT02927301

Run by

Genentech, Inc.

People needed

181

Starts

2017-04-20

Expected to finish

2023-09-05

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• UCLA Cancer Center — Santa Monica, California, United States
• University Of Colorado — Aurora, Colorado, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Emory University; Winship Cancer Institute — Atlanta, Georgia, United States
• Dana Farber Cancer Institute; Brigham and Womens Hospital — Boston, Massachusetts, United States
• Mass General/North Shore Cancer — Danvers, Massachusetts, United States
• Karmanos Cancer Inst; Hematology/Oncology — Detroit, Michigan, United States
• Washington University; Wash Uni. Sch. Of Med — St Louis, Missouri, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Memorial Sloan Kettering - Monmouth — Middletown, New Jersey, United States
• Memorial Sloan Kettering Cancer Center - Commack — Commack, New York, United States
• Memorial Sloan Kettering Cancer Center at Westchester — Harrison, New York, United States
• New York University Medical Center — New York, New York, United States
• Memorial Sloan Kettering - Basking Ridge — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Nassau — Uniondale, New York, United States
• The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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