A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)

Description

The purpose of this study is to determine the safety and effectiveness of nivolumab plus ipilimumab or nivolumab plus chemotherapy compared to chemotherapy alone in the treatment of Early Stage Non-Small Cell Lung This study has multiple primary endpoints. The first primary completion date of Pathological Complete Response is anticipated to be reached September 2020. The completion date for all primary outcome measures is expected May 2023.

Study Start Date

January, 13 2017

Estimated Completion Date

November 2028

Interventions

  • Drug: pemetrexed
  • Drug: vinorelbine
  • Drug: docetaxel
  • Biological: ipilimumab
  • Drug: cisplatin
  • Drug: carboplatin
  • Biological: Nivolumab
  • Drug: gemcitabine

Study ID

Bristol-Myers Squibb -- CA209-816

Status

Recruiting

Trial ID

NCT02998528

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

642

Sponsor

Bristol-Myers Squibb

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria

  • Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue
  • Lung function capacity capable of tolerating the proposed lung surgery
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Available tissue of primary lung tumor

Exclusion Criteria

  • Presence of locally advanced, inoperable or metastatic disease
  • Participants with active, known or suspected autoimmune disease
  • Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors) Other protocol defined inclusion/exclusion criteria could apply

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (152)

Study Location Distance Name Phone Email
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Mark Awad Site 0008 None None
Dana Farber Cancer Institute - Boston, Massachusetts 2.4 miles Mark Awad Site 0006 None None
Dana Farber Cancer Institute - Boston, Massachusetts 2.4 miles Mark Awad Site 0006 None None
Dana Farber Cancer Institute - Boston, Massachusetts 2.4 miles Mark Awad Site 0006 None None
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Mark Awad Site 0008 None None
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Mark Awad Site 0008 None None
Cancer Center Of Central Connecticut - Plainville, Connecticut 102.5 miles Brian Byrne Site 0007 None None
Cancer Center Of Central Connecticut - Plainville, Connecticut 102.5 miles Brian Byrne Site 0007 None None
Cancer Center Of Central Connecticut - Plainville, Connecticut 102.5 miles Brian Byrne Site 0007 None None
New York Oncology Hematology Pc - Albany, New York 139.4 miles Makenzi Evangelist Site 0027 None None
New York Oncology Hematology Pc - Albany, New York 139.4 miles Makenzi Evangelist Site 0027 None None
New York Oncology Hematology Pc - Albany, New York 139.4 miles Makenzi Evangelist Site 0027 None None
The Cancer Center At Hackensack University Medical Center - Hackensack, New Jersey 183.7 miles Harry Harper Site 0009 None None
The Cancer Center At Hackensack University Medical Center - Hackensack, New Jersey 183.7 miles Harry Harper Site 0009 None None
The Cancer Center At Hackensack University Medical Center - Hackensack, New Jersey 183.7 miles Harry Harper Site 0009 None None
Laura Isaac Perlmutter Cancer Center - New York, New York 186.5 miles Leena Gandhi Site 0011 None None
Laura Isaac Perlmutter Cancer Center - New York, New York 186.5 miles Leena Gandhi Site 0011 None None
Laura Isaac Perlmutter Cancer Center - New York, New York 186.5 miles Leena Gandhi Site 0011 None None
Fox Chase Cancer Center - Philadelphia, Pennsylvania 261.7 miles Hossein Borghaei Site 0010 None None
Fox Chase Cancer Center - Philadelphia, Pennsylvania 261.7 miles Hossein Borghaei Site 0010 None None
Fox Chase Cancer Center - Philadelphia, Pennsylvania 261.7 miles Hossein Borghaei Site 0010 None None
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins - Baltimore, Maryland 356.0 miles Patrick Forde Site 0001 None None
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins - Baltimore, Maryland 356.0 miles Patrick Forde Site 0001 None None
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins - Baltimore, Maryland 356.0 miles Patrick Forde Site 0001 None None
Virginia Cancer Specialists PC - Fairfax, Virginia 404.7 miles Alexander Spira Site 0125 None None
Virginia Cancer Specialists PC - Fairfax, Virginia 404.7 miles Alexander Spira Site 0125 None None
Virginia Cancer Specialists PC - Fairfax, Virginia 404.7 miles Alexander Spira Site 0125 None None
MetroHealth Medical Center - Cleveland, Ohio 549.6 miles Debora Bruno Site 0071 None None
MetroHealth Medical Center - Cleveland, Ohio 549.6 miles Debora Bruno Site 0071 None None
MetroHealth Medical Center - Cleveland, Ohio 549.6 miles Debora Bruno Site 0071 None None
Henry Ford Health System - Detroit, Michigan 612.3 miles Igor Rybkin Site 0012 None None
Henry Ford Health System - Detroit, Michigan 612.3 miles Igor Rybkin Site 0012 None None
Henry Ford Health System - Detroit, Michigan 612.3 miles Igor Rybkin Site 0012 None None
Christ Hospital - Cincinnati, Ohio 737.9 miles Manish Bhandari Site 0014 None None
Christ Hospital - Cincinnati, Ohio 737.9 miles Manish Bhandari Site 0014 None None
Christ Hospital - Cincinnati, Ohio 737.9 miles Manish Bhandari Site 0014 None None
Charleston Hematology Oncology Associates Pa - Charleston, South Carolina 822.7 miles Gene Saylors Site 0013 None None
Charleston Hematology Oncology Associates Pa - Charleston, South Carolina 822.7 miles Gene Saylors Site 0013 None None
Charleston Hematology Oncology Associates Pa - Charleston, South Carolina 822.7 miles Gene Saylors Site 0013 None None
University Of Chicago Medical Center - Chicago, Illinois 848.0 miles Everett Vokes Site 0002 773-834-7466 None
University Of Chicago Medical Center - Chicago, Illinois 848.0 miles Everett Vokes Site 0002 773-834-7466 None
University Of Chicago Medical Center - Chicago, Illinois 848.0 miles Everett Vokes Site 0002 773-834-7466 None
Illinois Cancer Specialists - Niles, Illinois 856.2 miles David Hakimian Site 0034 None None
Illinois Cancer Specialists - Niles, Illinois 856.2 miles David Hakimian Site 0034 None None
Illinois Cancer Specialists - Niles, Illinois 856.2 miles David Hakimian Site 0034 None None
Northwest Georgia Oncology Center PC - Marietta, Georgia 933.9 miles Steven Mccune Site 0103 None None
Northwest Georgia Oncology Center PC - Marietta, Georgia 933.9 miles Steven Mccune Site 0103 None None
Northwest Georgia Oncology Center PC - Marietta, Georgia 933.9 miles Steven Mccune Site 0103 None None
Tennessee Oncology Pc - Nashville, Tennessee 942.8 miles David Spigel Site 0092 None None
Tennessee Oncology Pc - Nashville, Tennessee 942.8 miles David Spigel Site 0092 None None
Tennessee Oncology Pc - Nashville, Tennessee 942.8 miles David Spigel Site 0092 None None
Cancer Institute Of Florida - Orlando, Florida 1,115.9 miles Tarek Mekhail Site 0054 None None
Cancer Institute Of Florida - Orlando, Florida 1,115.9 miles Tarek Mekhail Site 0054 None None
Cancer Institute Of Florida - Orlando, Florida 1,115.9 miles Tarek Mekhail Site 0054 None None
Hattiesburg Clinic - Hattiesburg, Mississippi 1,263.7 miles John Hrom Site 0090 601-288-2495 None
Hattiesburg Clinic - Hattiesburg, Mississippi 1,263.7 miles John Hrom Site 0090 601-288-2495 None
Hattiesburg Clinic - Hattiesburg, Mississippi 1,263.7 miles John Hrom Site 0090 601-288-2495 None
Texas Oncology - Bedford, Texas 1,566.2 miles Thomas Anderson Site 0024 None None
Texas Oncology - Bedford, Texas 1,566.2 miles Carl Chakmakjian Site 0026 None None
Texas Oncology - Bedford, Texas 1,566.2 miles Carl Chakmakjian Site 0026 None None
Texas Oncology - Bedford, Texas 1,566.2 miles Carl Chakmakjian Site 0026 None None
Texas Oncology - Bedford, Texas 1,566.2 miles Thomas Anderson Site 0024 None None
Texas Oncology - Bedford, Texas 1,566.2 miles Thomas Anderson Site 0024 None None
Texas Oncology PA South Austin Cancer Center - Austin, Texas 1,701.6 miles James Uyeki Site 0035 None None
Texas Oncology PA South Austin Cancer Center - Austin, Texas 1,701.6 miles James Uyeki Site 0035 None None
Texas Oncology PA South Austin Cancer Center - Austin, Texas 1,701.6 miles James Uyeki Site 0035 None None
Rocky Mountain Cancer Center - Denver, Colorado 1,766.9 miles Robert Jotte Site 0025 None None
Rocky Mountain Cancer Center - Denver, Colorado 1,766.9 miles Robert Jotte Site 0025 None None
Rocky Mountain Cancer Center - Denver, Colorado 1,766.9 miles Robert Jotte Site 0025 None None
St Vincent Frontier Cancer Center - Billings, Montana 1,862.8 miles Patrick Cobb Site 0063 None None
St Vincent Frontier Cancer Center - Billings, Montana 1,862.8 miles Patrick Cobb Site 0063 None None
St Vincent Frontier Cancer Center - Billings, Montana 1,862.8 miles Patrick Cobb Site 0063 None None
Huntsman Cancer Institute - Salt Lake City, Utah 2,094.1 miles Wallace Akerley Site 0003 801-585-0272 None
Huntsman Cancer Institute - Salt Lake City, Utah 2,094.1 miles Wallace Akerley Site 0003 801-585-0272 None
Huntsman Cancer Institute - Salt Lake City, Utah 2,094.1 miles Wallace Akerley Site 0003 801-585-0272 None
Arizona Oncology Assoc PcHal - Phoenix, Arizona 2,294.8 miles Abhimanyu Ghose Site 0121 602-277-4868 None
Arizona Oncology Assoc PcHal - Phoenix, Arizona 2,294.8 miles Abhimanyu Ghose Site 0121 602-277-4868 None
Arizona Oncology Assoc PcHal - Phoenix, Arizona 2,294.8 miles Abhimanyu Ghose Site 0121 602-277-4868 None
Comprehensive Cancer Centers of Nevada - Las Vegas, Nevada 2,380.5 miles Brian Vicuna Site 0032 None None
Comprehensive Cancer Centers of Nevada - Las Vegas, Nevada 2,380.5 miles Brian Vicuna Site 0032 None None
Comprehensive Cancer Centers of Nevada - Las Vegas, Nevada 2,380.5 miles Brian Vicuna Site 0032 None None
Los Angeles HematologyOncology Medical Group - Los Angeles, California 2,596.3 miles Lasika Seneviratne Site 0081 213-977-1214 None
Los Angeles HematologyOncology Medical Group - Los Angeles, California 2,596.3 miles Lasika Seneviratne Site 0081 213-977-1214 None
Los Angeles HematologyOncology Medical Group - Los Angeles, California 2,596.3 miles Lasika Seneviratne Site 0081 213-977-1214 None
Local Institution - Sacramento, California 2,626.1 miles Site 0097 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0105 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0107 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0099 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0100 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0102 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0084 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0094 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0033 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0083 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0136 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0137 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0015 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0089 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0134 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0104 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0053 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0114 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0004 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0140 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0139 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0117 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0096 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0021 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0128 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0106 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0087 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0082 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0065 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0135 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0022 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0023 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0079 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0077 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0078 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0073 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0072 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0076 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0075 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0074 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0138 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0091 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0016 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0059 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0060 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0064 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0061 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0113 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0058 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0062 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0019 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0048 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0049 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0131 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0118 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0111 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0109 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0133 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0123 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0127 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0108 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0119 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0132 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0124 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0126 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0120 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0110 None None
Local Institution - Sacramento, California 2,626.1 miles Site 0098 None None

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.