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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)

This study is currently recruiting participants.
Verified November 2017 by Genentech, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02927301
First Posted: October 7, 2016
Last Update Posted: November 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
  Purpose
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.

Condition Intervention Phase
Non-Small Cell Lung Cancer Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Percentage of Participants with Major Pathologic Response (MPR) [ Time Frame: After surgery (approximately 10 weeks) ]

Secondary Outcome Measures:
  • Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: After surgery (approximately 10 weeks) ]
  • Percentage of Participants with Objective Response According to RECIST Version 1.1 in Programmed Death Ligand 1 (PD-L1)-Positive Versus PD-L1-Negative Participants Based on Tumor Biomarkers [ Time Frame: After 12 weeks on study ]
  • Percentage of Participants with Adverse Events [ Time Frame: From Baseline until 90 days after end of treatment (approximately 16.5 months overall) ]

Estimated Enrollment: 180
Actual Study Start Date: April 20, 2017
Estimated Study Completion Date: October 31, 2024
Estimated Primary Completion Date: February 7, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atezolizumab
Participants will first receive two cycles of atezolizumab as neoadjuvant therapy prior to surgery. Participants who demonstrate clinical benefit will be eligible to receive up to 12 months of atezolizumab.
Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab will be given as 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.
Other Name: RO5541267, MPDL3280A

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Prior treatment with anti-PD-1 or PD-L1 therapies
  • History or risk of autoimmune disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927301


Contacts
Contact: Reference Study ID Number: ML39236 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010
Cedars Sinai Medical Center Withdrawn
Los Angeles, California, United States, 90048
UCLA Cancer Center Recruiting
Santa Monica, California, United States, 90404
United States, Colorado
University Of Colorado Recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06520
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33647
United States, Georgia
Emory University; Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30308
United States, Massachusetts
Dana Farber Cancer Institute; Brigham and Womens Hospital Recruiting
Boston, Massachusetts, United States, 02115
Mass General/North Shore Cancer Recruiting
Danvers, Massachusetts, United States, 01923
United States, Michigan
Karmanos Cancer Inst; Hematology/Oncology Recruiting
Detroit, Michigan, United States, 48201
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Memorial Sloan Kettering - Monmouth Recruiting
Middletown, New Jersey, United States, 07748
United States, New York
Memorial Sloan Kettering Cancer Center - Commack Recruiting
Commack, New York, United States, 11725
Memorial Sloan Kettering Cancer Center at Westchester Recruiting
Harrison, New York, United States, 10604
New York University Medical Center Recruiting
New York, New York, United States, 10036
Memorial Sloan Kettering - Basking Ridge Recruiting
New York, New York, United States, 10065
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
MSKC @ Rockville Recruiting
Rockville Centre, New York, United States, 11570
United States, Ohio
The Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pittsburgh Medical Center; Division of Hematology-Oncology Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02927301     History of Changes
Other Study ID Numbers: ML39236
First Submitted: October 5, 2016
First Posted: October 7, 2016
Last Update Posted: November 29, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Atezolizumab
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents