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) |
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.
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
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City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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650 Commack Rd
Commack, New York 11725
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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Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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5115 Centre Avenue
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
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