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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT02927301
First received: October 5, 2016
Last updated: June 16, 2017
Last verified: June 2017
  Purpose
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.

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: No masking
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, or IIIA 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 Based on Surgical Resection According to Criteria from Hellmann and Colleagues (2014) [ Time Frame: After surgery (approximately 10 weeks) ]

Secondary Outcome Measures:
  • Percentage of Participants with Objective Response According to 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: January 31, 2017
Estimated Study Completion Date: July 31, 2023
Estimated Primary Completion Date: July 31, 2023 (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

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, 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, 33612
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 Not yet recruiting
Boston, Massachusetts, United States, 02115
Mass General/North Shore Cancer Not yet 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 York
New York University Medical Center Not yet recruiting
New York, New York, United States, 10036
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
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 Not yet 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
Study First Received: October 5, 2016
Last Updated: June 16, 2017

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on June 22, 2017