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Non-Small Cell Lung CancerPhase 1/2CheckMate370NCT02574078

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

A Phase 1/2 study testing Nivolumab, Bevacizumab and Pemetrexed in people with Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 133 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Nivolumab, Bevacizumab and Pemetrexed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
341 participants
Where
133 sitesUnited States
Study dates
23 Nov 2015to 15 Apr 2020
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

133 sites in 1 country.

133 sites in 1 country

United States133 sites

  • Texas Oncology-Abilene

    Abilene, Texas, 79606

  • New York Oncology Hematology, Pc

    Albany, New York, 12208

  • Christus St. Francis Cabrini Cancer Center

    Alexandria, Louisiana, 71301

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • Texas Oncology - Amarillo

    Amarillo, Texas, 79106

  • Community Clinical Research Center

    Anderson, Indiana, 46011

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Texas Oncology-Arlington North

    Arlington, Texas, 76012

  • University Cancer Blood Ctr

    Athens, Georgia, 30607

  • Texas Oncology-Central Austin Cancer Center

    Austin, Texas, 78745

  • Comprehensive Blood And Cancer Center

    Bakersfield, California, 93309

  • University Of Maryland

    Baltimore, Maryland, 21201

  • Sinai Hospital Of Baltimore

    Baltimore, Maryland, 21215

  • Texas Oncology-Beaumont

    Beaumont, Texas, 77702

  • Texas Oncology

    Bedford, Texas, 76022

  • Center For Cancer And Blood Disorders

    Bethesda, Maryland, 20817

  • St. Luke's University Hospital Bethlehem

    Bethlehem, Pennsylvania, 18015

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59105

  • Alabama Oncology

    Birmingham, Alabama, 35205

  • Cancer Care Center

    Bismarck, North Dakota, 58501

  • Oncology & Hematology Associates Of Southwest Virginia, Inc.

    Blacksburg, Virginia, 24060

  • St. Louis Cancer Care, Llp

    Bridgeton, Missouri, 63044

  • Charleston Hematology Oncology Associates, Pa

    Charleston, South Carolina, 29414

  • Chattanooga Oncology Hematology Associates

    Chattanooga, Tennessee, 37404

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45242

  • Louis Stokes Cleveland VA Medical Center

    Cleveland, Ohio, 44106-1702

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Maryland Oncology Hematology, P.A.

    Columbia, Maryland, 21044

  • Mid Ohio Oncology Hematology

    Columbus, Ohio, 43219

  • Texas Oncology/Methodist Charlton Cancer Ctr

    Dallas, Texas, 75203

  • Texas Oncology

    Dallas, Texas, 75230

  • Texas Oncology

    Dallas, Texas, 75231

  • Texas Oncology, P.A.

    Dallas, Texas, 75246

  • Texas Oncology

    Denton, Texas, 76201

  • Bay Hematology Oncology

    Easton, Maryland, 21601

  • Minnesota Oncology Hematology, P.A.

    Edina, Minnesota, 55435

  • Texas Oncology

    El Paso, Texas, 79902

  • Erie Regional Cancer Center

    Erie, Pennsylvania, 16505

  • Oncology Associates Of Oregon, Pc

    Eugene, Oregon, 97401

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Virginia Cancer Specialists, Pc

    Fairfax, Virginia, 22031

  • Sanford Health

    Fargo, North Dakota, 58122

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401

  • Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • Texas Oncology

    Flower Mound, Texas, 75028

  • Florida Cancer Specialists S.

    Fort Myers, Florida, 33901

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Ft. Wayne Med Onco-Hema Inc

    Fort Wayne, Indiana, 46845

  • Texas Oncology

    Fort Worth, Texas, 76104

  • The Center For Cancer And Blood Disorders

    Fort Worth, Texas, 76104

  • St. Joseph Heritage Medical Group

    Fullerton, California, 92835

  • University of Florida at Shands

    Gainesville, Florida, 32610

  • The Jones Clinic, PC

    Germantown, Tennessee, 38138

  • West Cancer Center

    Germantown, Tennessee, 38138

  • Arizona Oncology Assoc, Pc-Hal

    Glendale, Arizona, 85308

  • Glens Falls Hospital

    Glens Falls, New York, 12801

  • St. Mary's Hospital Regional Cancer Center

    Grand Junction, Colorado, 81501

  • Cancer & Hematology Centers Of Western Michigan

    Grand Rapids, Michigan, 49503

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

  • Moses Cone Health System

    Greensboro, North Carolina, 27403

  • Randolph Cancer Center

    Greensboro, North Carolina, 27403

  • Greenville Health System

    Greenville, South Carolina, 29615

  • Forrest General Cancer Center

    Hattiesburg, Mississippi, 39401

  • Memorial Cancer Institute

    Hollywood, Florida, 33201

  • Abington Hematology Oncology Associates, Inc

    Horsham, Pennsylvania, 18944

  • Texas Oncology

    Houston, Texas, 77024

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Edwards Comprehensive Cancer Center

    Huntington, West Virginia, 25701

  • Jackson Oncology Associates, Pllc

    Jackson, Mississippi, 39202

  • Broome Oncology

    Johnson City, New York, 13790

  • Scripps Cancer Center

    La Jolla, California, 92037

  • Rocky Mountain Cancer Centers

    Lakewood, Colorado, 80228

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89128

  • Southeast Nebraska Cancer Center

    Lincoln, Nebraska, 68510

  • UCLA Hematology/Oncology Clinic

    Los Angeles, California, 90095

  • Hematology Oncology Associates

    Medford, Oregon, 97504

  • Texas Cancer Center Of Mesquite

    Mesquite, Texas, 75150

  • East Jefferson General Hospital

    Metairie, Louisiana, 70006

  • Baptist Health Medical Group Oncology

    Miami, Florida, 33176

  • Texas Oncology, Pa

    Midland, Texas, 79701

  • Southern Cancer Center Pc

    Mobile, Alabama, 36608

  • Summit Medical Group

    Morristown, New Jersey, 07960

  • Northern Westchester Hospital

    Mount Kisco, New York, 10549

  • Tennessee Oncology, PLLC - SCRI - PPDS

    Nashville, Tennessee, 37203

  • Texas Oncology

    New Braunfels, Texas, 78130

  • Columbia University Medical Center (Cumc)

    New York, New York, 10032

  • Cancer Treatment Centers Of America

    Newnan, Georgia, 30265

  • Illinois Cancer Specialists

    Niles, Illinois, 60714

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Eastern Ct Hem Onc Assoc

    Norwich, Connecticut, 06360

  • Hematology-Oncology Associates Of Rockland

    Nyack, New York, 10960

  • Ocala Oncology Center

    Ocala, Florida, 34471

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • West KY Hematology Oncology Group PSC

    Paducah, Kentucky, 42003

  • Texas Oncology

    Paris, Texas, 75460

  • First Health Of The Carolinas

    Pinehurst, North Carolina, 28374

  • Texas Oncology-Plano East

    Plano, Texas, 75075-7787

  • Texas Oncology Plano West Cancer Center

    Plano, Texas, 75093

  • Hematology Oncology Associates Of The Treasure Coast

    Port Saint Lucie, Florida, 34952

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • W.G. Bill Hefner VA Medical Center

    Salisbury, North Carolina, 28144

  • Cancer Centers of South Texas

    San Antonio, Texas, 78212

  • Coastal Integrative Cancer Care

    San Luis Obispo, California, 93401

  • Central Coast Med Oncology

    Santa Maria, California, 93454

  • Summit Cancer Care

    Savannah, Georgia, 31405

  • New England Cancer Specialists

    Scarborough, Maine, 04074

  • Northern Arizona Hematology & Oncology Associates

    Sedona, Arizona, 86336

  • Texas Cancer Center - Sherman

    Sherman, Texas, 75090

  • Sanford Research

    Sioux Falls, South Dakota, 57104

  • Local Institution

    Solvang, California, 93463

  • Cancer Care Northwest

    Spokane Valley, Washington, 99216

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • Stamford Hospital

    Stamford, Connecticut, 06904

  • Texas Oncology Cancer Center - Sugar Land

    Sugar Land, Texas, 77479

  • Atlantic Health System

    Summit, New Jersey, 07901

  • Morristown Medical Center

    Summit, New Jersey, 07901

  • Tallahassee Memorial Cancer Center

    Tallahassee, Florida, 32308

  • Lewis Hall Singletary Oncology Center

    Thomasville, Georgia, 31792

  • Cotton-O-Neil Clinical Research Center

    Topeka, Kansas, 66606

  • Florida Cancer Affiliates

    Trinity, Florida, 34655

  • Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope

    Tucson, Arizona, 85704

  • Arizona Clinical Research Center, Inc.

    Tucson, Arizona, 85715

  • Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research

    Tulsa, Oklahoma, 74146

  • Texas Oncology-Tyler

    Tyler, Texas, 75702

  • Northwest Cancer Specialists, Pc

    Vancouver, Washington, 98684

  • Texas Oncology Cancer Care And Research Center

    Waco, Texas, 76712

  • Texas Oncology, P.A.

    Webster, Texas, 77598-4420

  • Texas Oncology

    Weslaco, Texas, 78596

  • Va Ct Healthcare System

    West Haven, Connecticut, 06516

  • White Plains Hospital

    White Plains, New York, 10601

  • Texas Oncology-Wichita Falls

    Wichita Falls, Texas, 76310

  • Shenandoah Oncology

    Winchester, Virginia, 22601

  • Yakima Valley Memorial Hospital/North Star Lodge

    Yakima, Washington, 98902

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Nivolumab, Bevacizumab, Pemetrexed, Best Supportive Care, nab-Paclitaxel
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02574078
Study groupRoleWhat they receive
Group A NivolumabExperimentalOpdivo specified dose on specified days
Receives: Drug: Nivolumab
Group A Nivolumab + SOC maintenance therapyExperimentalOpdivo/Bevacizumab specified dose on specified days Opdivo/Pemetrexed specified dose on specified days
Receives: Drug: Nivolumab; Drug: Bevacizumab; Drug: Pemetrexed
Group A SOC maintenance therapyActive comparatorBevacizumab specified dose on specified days Pemetrexed specified dose on specified days
Receives: Drug: Bevacizumab; Drug: Pemetrexed
Group B NivolumabExperimentalOpdivo specified dose on specified days
Receives: Drug: Nivolumab
Group B Best supportive careOtherTherapy directed against specific symptoms of disease, i.e., palliative radiation or palliative surgery
Receives: Other: Best Supportive Care
Group C Investigator's choice chemotherapyActive comparatorCarboplatin/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
Receives: Drug: Pemetrexed; Drug: nab-Paclitaxel; Drug: Paclitaxel; Drug: Docetaxel; Drug: Gemcitabine; Drug: Carboplatin
Group C NivolumbExperimentalOpdivo specified dose on specified days
Receives: Drug: Nivolumab
Group D ErlotinibActive comparatorErlotinib specified dose on specified days
Receives: Drug: Erlotinib
Group D Nivolumab + ErlotinibExperimentalOpdivo/Erlotnib specified dose on specified days
Receives: Drug: Nivolumab; Drug: Erlotinib
Group E Nivolumab + CrizotinibExperimentalOpdivo/Crizotinib specified dose on specified days
Receives: Drug: Nivolumab; Drug: Crizotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS), Groups A-D Only

    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.

    Measured: up to approximately 48 months

  2. Overall Survival (OS), Groups A-C Only

    Overall survival (OS) is defined as the time from randomization to the date of death.

    Measured: up to approximately 60 months

  3. Percentage of Participants With Treatment-related Adverse Events (AEs) Leading to Both Study Drugs Discontinuation, Group E Only

    Percentage of participants who experienced a treatment-related AE during the course of the study that lead to discontinuation of both study drugs.

    Measured: up to approximately 60 months

Secondary outcomes (4)

  1. Duration of Response (DOR), Groups A-D Only

    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.

    Measured: up to approximately 48 months

  2. Objective Response Rate (ORR), Groups A-E

    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.

    Measured: up to approximately 48 months

  3. Overall Survival (OS), Group D Only

    Overall survival (OS) is defined as the time from randomization to the date of death.

    Measured: up to approximately 60 months

  4. Progression-Free Survival (PFS), Group E Only

    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.

    Measured: up to approximately 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2015 (estimated)
  2. Study start23 Nov 2015
  3. Primary completion15 Apr 2020
  4. Study completion15 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
341 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02574078
Sponsor's protocol ID
CA209-370
Acronym
CheckMate370
Status last verified
Apr 2021
First submitted
9 Oct 2015
Last updated
6 May 2021
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Nivolumab, Bevacizumab and Pemetrexed in people with Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 133 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 133 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS), Groups A-D Only (time frame: up to approximately 48 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02574078.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.

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