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

NCT ID: NCT02927301

Last Updated: 2024-09-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-20

Study Completion Date

2023-09-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody

Intervention Type DRUG

Atezolizumab was given as 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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RO5541267, MPDL3280A

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

UCLA Cancer Center

Santa Monica, California, United States

Site Status

University Of Colorado

Aurora, Colorado, United States

Site Status

Yale Cancer Center

New Haven, Connecticut, United States

Site Status

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Emory University; Winship Cancer Institute

Atlanta, Georgia, United States

Site Status

Dana Farber Cancer Institute; Brigham and Womens Hospital

Boston, Massachusetts, United States

Site Status

Mass General/North Shore Cancer

Danvers, Massachusetts, United States

Site Status

Karmanos Cancer Inst; Hematology/Oncology

Detroit, Michigan, United States

Site Status

Washington University; Wash Uni. Sch. Of Med

St Louis, Missouri, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Memorial Sloan Kettering - Monmouth

Middletown, New Jersey, United States

Site Status

Memorial Sloan Kettering Cancer Center - Commack

Commack, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center at Westchester

Harrison, New York, United States

Site Status

New York University Medical Center

New York, New York, United States

Site Status

Memorial Sloan Kettering - Basking Ridge

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Site Status

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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Chaft JE, Oezkan F, Kris MG, Bunn PA, Wistuba II, Kwiatkowski DJ, Owen DH, Tang Y, Johnson BE, Lee JM, Lozanski G, Pietrzak M, Seweryn M, Byun WY, Schulze K, Nicholas A, Johnson A, Grindheim J, Hilz S, Shames DS, Rivard C, Toloza E, Haura EB, McNamee CJ, Patterson GA, Waqar SN, Rusch VW, Carbone DP; LCMC study investigators. Neoadjuvant atezolizumab for resectable non-small cell lung cancer: an open-label, single-arm phase II trial. Nat Med. 2022 Oct;28(10):2155-2161. doi: 10.1038/s41591-022-01962-5. Epub 2022 Sep 12.

Reference Type DERIVED
PMID: 36097216 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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ML39236

Identifier Type: -

Identifier Source: org_study_id

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