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

Part of paid clinical trials in Duarte, California.

Sponsor
Genentech, Inc.
Study ID
NCT02927301
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Apr 20, 2017
Status verified
Aug 2024
Primary completion
May 7, 2020
Completion
Sep 5, 2023

Study Design

Enrollment
181 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab
    Participants received two cycles of atezolizumab as neoadjuvant therapy prior to surgery. Participants who demonstrated clinical benefit were eligible to receive up to 12 months of atezolizumab.

Primary Outcome Measure

Percentage of Participants With Major Pathologic Response (MPR) [ Time Frame: After surgery (approximately 10 weeks) ]

Locations (19)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
UCLA Cancer CenterSanta MonicaCalifornia90404-
University Of ColoradoAuroraColorado80045-
Yale Cancer CenterNew HavenConnecticut06520-
Moffitt Cancer CenterTampaFlorida33612-
Emory University; Winship Cancer InstituteAtlantaGeorgia30308-
Dana Farber Cancer Institute; Brigham and Womens HospitalBostonMassachusetts02115-
Mass General/North Shore CancerDanversMassachusetts01923-
Karmanos Cancer Inst; Hematology/OncologyDetroitMichigan48201-
Washington University; Wash Uni. Sch. Of MedSt LouisMissouri63110-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756-
Memorial Sloan Kettering - MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering Cancer Center - CommackCommackNew York11725-
Memorial Sloan Kettering Cancer Center at WestchesterHarrisonNew York10604-
Memorial Sloan Kettering - Basking RidgeNew YorkNew York10065-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
New York University Medical CenterNew YorkNew York10036-
Memorial Sloan Kettering NassauUniondaleNew York11553-
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

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