A Study of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Stage IB, II, or IIIA Resectable and Untreated Non-Small Cell Lung Cancer (NSCLC)

Description

This study is designed to evaluate the safety and efficacy of neoadjuvant and adjuvant atezolizumab in participants with Stage IB, II, or IIIA NSCLC who are eligible for surgical resection with curative intent. 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.

Study Start Date

January, 31 2017

Estimated Completion Date

July 2023

Interventions

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

Study ID

Genentech, Inc. -- ML39236

Status

Recruiting

Trial ID

NCT02927301

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

180

Sponsor

Genentech, Inc.

Inclusion Criteria

  • Pathologically documented Stage IB, II, or IIIA NSCLC and eligible for surgical resection with curative intent
  • Adequate pulmonary and cardiac function
  • Available biopsy of primary tumor with adequate samples
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate hematologic and end-organ function
  • Agreement to remain abstinent or use appropriate contraception, among women of childbearing potential

Exclusion Criteria

  • NSCLC that is clinically tumor size T3 by virtue of multiple tumor nodules within the same lobe
  • Any prior therapy for lung cancer
  • Prior treatment with anti-PD-1 or PD-L1 therapies
  • Major surgery within 28 days prior to Day 1 of Cycle 1
  • Malignancies other than NSCLC within 3 years prior to Day 1 of Cycle 1 except curatively treated malignancies with a negligible risk of metastasis or death
  • History or risk of autoimmune disease
  • Hepatitis B or C or human immunodeficiency virus (HIV) infection
  • Administration of live attenuated vaccines within 4 weeks before Day 1 of Cycle 1
  • Severe infections within 4 weeks prior to Day 1 of Cycle 1
  • Treatment with an investigational agent within 4 weeks or five half-lives prior to Day 1 of Cycle 1
  • History of severe hypersensitivity to chimeric or humanized antibodies or fusion proteins
  • Pregnant or lactating

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (58)

Study Location Distance Name Phone Email
Dana Farber Cancer Institute Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles None None None
Dana Farber Cancer Institute Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles None None None
Dana Farber Cancer Institute Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles None None None
Dana Farber Cancer Institute Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles None None None
Dana Farber Cancer Institute Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles None None None
Mass GeneralNorth Shore Cancer - Danvers, Massachusetts 16.4 miles None None None
Mass GeneralNorth Shore Cancer - Danvers, Massachusetts 16.4 miles None None None
Mass GeneralNorth Shore Cancer - Danvers, Massachusetts 16.4 miles None None None
Mass GeneralNorth Shore Cancer - Danvers, Massachusetts 16.4 miles None None None
Mass GeneralNorth Shore Cancer - Danvers, Massachusetts 16.4 miles None None None
Dartmouth Hitchcock Medical Center - Lebanon, New Hampshire 105.5 miles None None None
Yale Cancer Center - New Haven, Connecticut 119.2 miles None None None
Memorial Sloan Kettering Cancer Center Commack - Commack, New York 154.4 miles None None None
Memorial Sloan Kettering Cancer Center Commack - Commack, New York 154.4 miles None None None
Memorial Sloan Kettering Cancer Center Commack - Commack, New York 154.4 miles None None None
Memorial Sloan Kettering Cancer Center Commack - Commack, New York 154.4 miles None None None
Memorial Sloan Kettering Cancer Center Commack - Commack, New York 154.4 miles None None None
Memorial Sloan Kettering Cancer Center at Westchester - Harrison, New York 164.7 miles None None None
MSKC Rockville - Rockville Centre, New York 176.5 miles None None None
MSKC Rockville - Rockville Centre, New York 176.5 miles None None None
MSKC Rockville - Rockville Centre, New York 176.5 miles None None None
MSKC Rockville - Rockville Centre, New York 176.5 miles None None None
MSKC Rockville - Rockville Centre, New York 176.5 miles None None None
New York University Medical Center - New York, New York 186.5 miles None None None
Memorial Sloan Kettering Basking Ridge - New York, New York 187.1 miles None None None
Memorial Sloan Kettering Cancer Center - New York, New York 187.1 miles None None None
Memorial Sloan Kettering Basking Ridge - New York, New York 187.1 miles None None None
Memorial Sloan Kettering Basking Ridge - New York, New York 187.1 miles None None None
Memorial Sloan Kettering Basking Ridge - New York, New York 187.1 miles None None None
Memorial Sloan Kettering Basking Ridge - New York, New York 187.1 miles None None None
Memorial Sloan Kettering Monmouth - Middletown, New Jersey 207.4 miles None None None
Memorial Sloan Kettering Monmouth - Middletown, New Jersey 207.4 miles None None None
Memorial Sloan Kettering Monmouth - Middletown, New Jersey 207.4 miles None None None
Memorial Sloan Kettering Monmouth - Middletown, New Jersey 207.4 miles None None None
Memorial Sloan Kettering Monmouth - Middletown, New Jersey 207.4 miles None None None
University of Pittsburgh Medical Center Division of HematologyOncology - Pittsburgh, Pennsylvania 477.2 miles None None None
University of Pittsburgh Medical Center Division of HematologyOncology - Pittsburgh, Pennsylvania 477.2 miles None None None
University of Pittsburgh Medical Center Division of HematologyOncology - Pittsburgh, Pennsylvania 477.2 miles None None None
University of Pittsburgh Medical Center Division of HematologyOncology - Pittsburgh, Pennsylvania 477.2 miles None None None
University of Pittsburgh Medical Center Division of HematologyOncology - Pittsburgh, Pennsylvania 477.2 miles None None None
Karmanos Cancer Inst HematologyOncology - Detroit, Michigan 611.5 miles None None None
Karmanos Cancer Inst HematologyOncology - Detroit, Michigan 611.5 miles None None None
Karmanos Cancer Inst HematologyOncology - Detroit, Michigan 611.5 miles None None None
Karmanos Cancer Inst HematologyOncology - Detroit, Michigan 611.5 miles None None None
Karmanos Cancer Inst HematologyOncology - Detroit, Michigan 611.5 miles None None None
The Ohio State University Comprehensive Cancer Center - Columbus, Ohio 641.8 miles None None None
Emory University Winship Cancer Institute - Atlanta, Georgia 935.3 miles None None None
Emory University Winship Cancer Institute - Atlanta, Georgia 935.3 miles None None None
Emory University Winship Cancer Institute - Atlanta, Georgia 935.3 miles None None None
Emory University Winship Cancer Institute - Atlanta, Georgia 935.3 miles None None None
Emory University Winship Cancer Institute - Atlanta, Georgia 935.3 miles None None None
Washington University - Saint Louis, Missouri 1,039.5 miles None None None
Moffitt Cancer Center - Tampa, Florida 1,178.7 miles None None None
Baylor College of Medicine - Houston, Texas 1,609.9 miles None None None
University Of Colorado - Aurora, Colorado 1,759.8 miles None None None
City of Hope Comprehensive Cancer Center - Duarte, California 2,578.2 miles None None None
Cedars Sinai Medical Center - Los Angeles, California 2,601.4 miles None None None
UCLA Cancer Center - Santa Monica, California 2,607.9 miles None None None

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