A Study of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) - Lung Cancer Mutation Consortium (LCMC3)
NCT02927301 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 181
Last updated 2024-09-19
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.
Conditions
Interventions
- DRUG
-
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab was given as 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.
Sponsors & Collaborators
-
Genentech, Inc.
lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-04-20
- Primary Completion
- 2020-05-07
- Completion
- 2023-09-05
- FDA Drug
- Yes
Countries
- United States
Study Locations
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