A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC) (CheckMate370)

April 12, 2021 updated by: Bristol-Myers Squibb

A Master Protocol of Phase 1/2 Studies of Nivolumab in Advanced NSCLC Using Nivolumab as Maintenance After Induction Chemotherapy or as First-line Treatment Alone or in Combination With Standard of Care Therapies (CheckMate 370: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 370)

The purpose of this study is to determine whether nivolumab monotherapy or in combination with Standard of care (SOC) therapies will provide clinical benefit (i.e., PFS, OS, and DOR) without unacceptable toxicity in advanced Non-Small Cell Lung Cancer patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK)

**Please note that the study is no longer enrolling patients for Groups A, B, C, and E.

Study Type

Interventional

Enrollment (Actual)

341

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Alabama Oncology
      • Mobile, Alabama, United States, 36608
        • Southern Cancer Center Pc
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Arizona Oncology Assoc, Pc-Hal
      • Sedona, Arizona, United States, 86336
        • Northern Arizona Hematology & Oncology Associates
      • Tucson, Arizona, United States, 85715
        • Arizona Clinical Research Center, Inc.
      • Tucson, Arizona, United States, 85704
        • Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope
    • California
      • Bakersfield, California, United States, 93309
        • Comprehensive Blood And Cancer Center
      • Fullerton, California, United States, 92835
        • St. Joseph Heritage Medical Group
      • La Jolla, California, United States, 92037
        • Scripps Cancer Center
      • Los Angeles, California, United States, 90095
        • UCLA Hematology/Oncology Clinic
      • San Luis Obispo, California, United States, 93401
        • Coastal Integrative Cancer Care
      • Santa Maria, California, United States, 93454
        • Central Coast Med Oncology
      • Solvang, California, United States, 93463
        • Local Institution
    • Colorado
      • Grand Junction, Colorado, United States, 81501
        • St. Mary's Hospital Regional Cancer Center
      • Lakewood, Colorado, United States, 80228
        • Rocky Mountain Cancer Centers
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Eastern Ct Hem Onc Assoc
      • Stamford, Connecticut, United States, 06904
        • Stamford Hospital
      • West Haven, Connecticut, United States, 06516
        • VA CT Healthcare System
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists S.
      • Gainesville, Florida, United States, 32610
        • University of Florida at Shands
      • Hollywood, Florida, United States, 33201
        • Memorial Cancer Institute
      • Miami, Florida, United States, 33176
        • Baptist Health Medical Group Oncology
      • Ocala, Florida, United States, 34471
        • Ocala Oncology Center
      • Port Saint Lucie, Florida, United States, 34952
        • Hematology Oncology Associates of the Treasure Coast
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Memorial Cancer Center
      • Trinity, Florida, United States, 34655
        • Florida Cancer Affiliates
    • Georgia
      • Athens, Georgia, United States, 30607
        • University Cancer Blood Ctr
      • Newnan, Georgia, United States, 30265
        • Cancer Treatment Centers of America
      • Savannah, Georgia, United States, 31405
        • Summit Cancer Care
      • Thomasville, Georgia, United States, 31792
        • Lewis Hall Singletary Oncology Center
    • Illinois
      • Niles, Illinois, United States, 60714
        • Illinois Cancer Specialists
    • Indiana
      • Anderson, Indiana, United States, 46011
        • Community Clinical Research Center
      • Fort Wayne, Indiana, United States, 46845
        • Ft. Wayne Med Onco-Hema Inc
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton-O-Neil Clinical Research Center
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • West KY Hematology Oncology Group PSC
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Christus St. Francis Cabrini Cancer Center
      • Metairie, Louisiana, United States, 70006
        • East Jefferson General Hospital
    • Maine
      • Scarborough, Maine, United States, 04074
        • New England Cancer Specialists
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Medical Center
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer and Blood Disorders
      • Columbia, Maryland, United States, 21044
        • Maryland Oncology Hematology, P.A.
      • Easton, Maryland, United States, 21601
        • Bay Hematology Oncology
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Cancer & Hematology Centers of Western Michigan
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Minnesota Oncology Hematology, P.A.
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Forrest General Cancer Center
      • Jackson, Mississippi, United States, 39202
        • Jackson Oncology Associates, PLLC
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • St. Louis Cancer Care, LLP
    • Montana
      • Billings, Montana, United States, 59105
        • Saint Vincent Frontier Cancer Center
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Southeast Nebraska Cancer Center
      • Omaha, Nebraska, United States, 68130
        • Nebraska Cancer Specialists
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • Flemington, New Jersey, United States, 08822
        • Hunterdon Medical Center
      • Morristown, New Jersey, United States, 07960
        • Summit Medical Group
      • Summit, New Jersey, United States, 07901
        • Atlantic Health System
      • Summit, New Jersey, United States, 07901
        • Morristown Medical Center
    • New Mexico
      • Farmington, New Mexico, United States, 87401
        • San Juan Oncology Associates
    • New York
      • Albany, New York, United States, 12208
        • New York Oncology Hematology, PC
      • Glens Falls, New York, United States, 12801
        • Glens Falls Hospital
      • Johnson City, New York, United States, 13790
        • Broome Oncology
      • Mount Kisco, New York, United States, 10549
        • Northern Westchester Hospital
      • New York, New York, United States, 10032
        • Columbia University Medical Center (Cumc)
      • Nyack, New York, United States, 10960
        • Hematology-Oncology Associates of Rockland
      • White Plains, New York, United States, 10601
        • White Plains Hospital
    • North Carolina
      • Greensboro, North Carolina, United States, 27403
        • Cone Health Cancer Center
      • Greensboro, North Carolina, United States, 27403
        • Moses Cone Health System
      • Greensboro, North Carolina, United States, 27403
        • Randolph Cancer Center
      • Pinehurst, North Carolina, United States, 28374
        • First Health of the Carolinas
      • Salisbury, North Carolina, United States, 28144
        • W.G. Bill Hefner VA Medical Center
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Cancer Care Center
      • Fargo, North Dakota, United States, 58122
        • Sanford Health
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care, Inc.
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, United States, 44106-1702
        • Louis Stokes Cleveland VA Medical Center
      • Columbus, Ohio, United States, 43219
        • Mid Ohio Oncology Hematology
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oncology Associates of Oregon, PC
      • Medford, Oregon, United States, 97504
        • Hematology Oncology Associates
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's University Hospital Bethlehem
      • Erie, Pennsylvania, United States, 16505
        • Erie Regional Cancer Center
      • Horsham, Pennsylvania, United States, 18944
        • Abington Hematology Oncology Associates, Inc
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Charleston Hematology Oncology Associates, PA
      • Greenville, South Carolina, United States, 29615
        • Greenville Health System
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Research
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Oncology Hematology Associates
      • Germantown, Tennessee, United States, 38138
        • The Jones Clinic, PC
      • Germantown, Tennessee, United States, 38138
        • West Cancer Center
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology, PLLC - SCRI - PPDS
    • Texas
      • Abilene, Texas, United States, 79606
        • Texas Oncology-Abilene
      • Amarillo, Texas, United States, 79106
        • Texas Oncology - Amarillo
      • Arlington, Texas, United States, 76012
        • Texas Oncology-Arlington North
      • Austin, Texas, United States, 78745
        • Texas Oncology-Central Austin Cancer Center
      • Beaumont, Texas, United States, 77702
        • Texas Oncology-Beaumont
      • Bedford, Texas, United States, 76022
        • Texas Oncology
      • Dallas, Texas, United States, 75246
        • Texas Oncology, P.A.
      • Dallas, Texas, United States, 75230
        • Texas Oncology
      • Dallas, Texas, United States, 75231
        • Texas Oncology
      • Dallas, Texas, United States, 75203
        • Texas Oncology/Methodist Charlton Cancer Ctr
      • Denton, Texas, United States, 76201
        • Texas Oncology
      • El Paso, Texas, United States, 79902
        • Texas Oncology
      • Flower Mound, Texas, United States, 75028
        • Texas Oncology
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology
      • Fort Worth, Texas, United States, 76104
        • The Center for Cancer and Blood Disorders
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
      • Houston, Texas, United States, 77024
        • Texas Oncology
      • Mesquite, Texas, United States, 75150
        • Texas Cancer Center of Mesquite
      • Midland, Texas, United States, 79701
        • Texas Oncology, PA
      • New Braunfels, Texas, United States, 78130
        • Texas Oncology
      • Paris, Texas, United States, 75460
        • Texas Oncology
      • Plano, Texas, United States, 75075-7787
        • Texas Oncology-Plano East
      • Plano, Texas, United States, 75093
        • Texas Oncology Plano West Cancer Center
      • San Antonio, Texas, United States, 78212
        • Cancer Centers of South Texas
      • Sherman, Texas, United States, 75090
        • Texas Cancer Center - Sherman
      • Sugar Land, Texas, United States, 77479
        • Texas Oncology Cancer Center - Sugar Land
      • Tyler, Texas, United States, 75702
        • Texas Oncology-Tyler
      • Waco, Texas, United States, 76712
        • Texas Oncology Cancer Care and Research Center
      • Webster, Texas, United States, 77598-4420
        • Texas Oncology, P.A.
      • Weslaco, Texas, United States, 78596
        • Texas Oncology
      • Wichita Falls, Texas, United States, 76310
        • Texas Oncology-Wichita Falls
    • Virginia
      • Blacksburg, Virginia, United States, 24060
        • Oncology & Hematology Associates Of Southwest Virginia, Inc.
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists, PC
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
      • Richmond, Virginia, United States, 23230
        • Virginia Cancer Institute
      • Winchester, Virginia, United States, 22601
        • Shenandoah Oncology
    • Washington
      • Everett, Washington, United States, 98201
        • Providence Regional Cancer Partnership
      • Spokane Valley, Washington, United States, 99216
        • Cancer Care Northwest
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists, PC
      • Yakima, Washington, United States, 98902
        • Yakima Valley Memorial Hospital/North Star Lodge
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Edwards Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Histologically confirmed locally advanced or stage IV NSCLC
  • Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
  • Tumor tissue sections must be available for biomarker evaluation

Exclusion Criteria:

  • Untreated or active/progressing Central Nervous system (CNS) metastases
  • Active, known or suspected autoimmune disease
  • Known history of testing positive for HIV or AIDS
  • Active or chronic infection of hepatitis B virus or hepatitis C

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A Nivolumab
Opdivo specified dose on specified days
Drug: Nivolumab
Other Names:
  • Opdivo
Experimental: Group A Nivolumab + SOC maintenance therapy

Opdivo/Bevacizumab specified dose on specified days

Opdivo/Pemetrexed specified dose on specified days
Drug: Pemetrexed
Drug: Nivolumab
Other Names:
  • Opdivo
Drug: Bevacizumab
Active Comparator: Group A SOC maintenance therapy

Bevacizumab specified dose on specified days

Pemetrexed specified dose on specified days
Drug: Pemetrexed
Drug: Bevacizumab
Experimental: Group B Nivolumab
Opdivo specified dose on specified days
Drug: Nivolumab
Other Names:
  • Opdivo
Other: Group B Best supportive care
Therapy directed against specific symptoms of disease, i.e., palliative radiation or palliative surgery
Other: Best Supportive Care
Palliative radiation, palliative surgery and/or other best supportive care treatments
Active Comparator: Group C Investigator's choice chemotherapy

Carboplatin/nab-paclitaxel specified dose on specified days

Carboplatin/paclitaxel specified dose on specified days

Carboplatin/pemetrexed specified dose on specified days

Carboplatin/docetaxel specified dose on specified days

Carboplatin/gemcitabine specified dose on specified days

Paclitaxel specified dose on specified days

Docetaxel specified dose on specified days

Gemcitabine specified dose on specified days

Pemetrexed specified dose on specified days
Drug: Gemcitabine
Drug: Docetaxel
Drug: Pemetrexed
Drug: Carboplatin
Drug: Paclitaxel
Drug: nab-Paclitaxel
Experimental: Group C Nivolumb
Opdivo specified dose on specified days
Drug: Nivolumab
Other Names:
  • Opdivo
Active Comparator: Group D Erlotinib
Erlotinib specified dose on specified days
Drug: Erlotinib
Experimental: Group D Nivolumab + Erlotinib
Opdivo/Erlotnib specified dose on specified days
Drug: Erlotinib
Drug: Nivolumab
Other Names:
  • Opdivo
Experimental: Group E Nivolumab + Crizotinib
Opdivo/Crizotinib specified dose on specified days
Drug: Nivolumab
Other Names:
  • Opdivo
Drug: Crizotinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS), Groups A-D Only
Time Frame: up to approximately 48 months
Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first.
up to approximately 48 months
Overall Survival (OS), Groups A-C Only
Time Frame: up to approximately 60 months
Overall survival (OS) is defined as the time from randomization to the date of death.
up to approximately 60 months
Percentage of Participants With Treatment-related Adverse Events (AEs) Leading to Both Study Drugs Discontinuation, Group E Only
Time Frame: up to approximately 60 months
Percentage of participants who experienced a treatment-related AE during the course of the study that lead to discontinuation of both study drugs.
up to approximately 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR), Groups A-D Only
Time Frame: up to approximately 48 months

Duration of response (DOR) is defined as the time from first confirmed response (complete response (CR) or partial response (PR)) to the date of the initial objectively documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first.

Median computed using Kaplan-Meier method.
up to approximately 48 months
Objective Response Rate (ORR), Groups A-E
Time Frame: up to approximately 48 months

Objective response rate (ORR) is defined as the number and percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). Best overall response (BOR) is defined as the best response designation, recorded between the date of first dose and the date of the initial objectively documented tumor progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first.

Confidence interval based on the Clopper and Pearson method.
up to approximately 48 months
Overall Survival (OS), Group D Only
Time Frame: up to approximately 60 months
Overall survival (OS) is defined as the time from randomization to the date of death.
up to approximately 60 months
Progression-Free Survival (PFS), Group E Only
Time Frame: up to approximately 48 months
Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first.
up to approximately 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2015

Primary Completion (Actual)

April 15, 2020

Study Completion (Actual)

April 15, 2020

Study Registration Dates

First Submitted

October 9, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimate)

October 12, 2015

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

April 12, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-370

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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