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

Non-Small Cell Lung Cancer Clinical Trial

— CheckMate370  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574078
• Other study ID #: CA209-370
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 23, 2015
• Est. completion date: April 15, 2020

Study information

• Verified date: April 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: April 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Nivolumab

• Bevacizumab

• Pemetrexed

Other:
• Best Supportive Care
Palliative radiation, palliative surgery and/or other best supportive care treatments

Drug:
• nab-Paclitaxel

• Paclitaxel

• Docetaxel

• Gemcitabine

• Erlotinib

• Crizotinib

• Carboplatin

Locations

Country	Name	City	State
United States	Texas Oncology-Abilene	Abilene	Texas
United States	New York Oncology Hematology, Pc	Albany	New York
United States	Christus St. Francis Cabrini Cancer Center	Alexandria	Louisiana
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Texas Oncology - Amarillo	Amarillo	Texas
United States	Community Clinical Research Center	Anderson	Indiana
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	Texas Oncology-Arlington North	Arlington	Texas
United States	University Cancer Blood Ctr	Athens	Georgia
United States	Texas Oncology-Central Austin Cancer Center	Austin	Texas
United States	Comprehensive Blood And Cancer Center	Bakersfield	California
United States	Sinai Hospital Of Baltimore	Baltimore	Maryland
United States	University Of Maryland	Baltimore	Maryland
United States	Texas Oncology-Beaumont	Beaumont	Texas
United States	Texas Oncology	Bedford	Texas
United States	Center For Cancer And Blood Disorders	Bethesda	Maryland
United States	St. Luke's University Hospital Bethlehem	Bethlehem	Pennsylvania
United States	Saint Vincent Frontier Cancer Center	Billings	Montana
United States	Alabama Oncology	Birmingham	Alabama
United States	Cancer Care Center	Bismarck	North Dakota
United States	Oncology & Hematology Associates Of Southwest Virginia, Inc.	Blacksburg	Virginia
United States	St. Louis Cancer Care, Llp	Bridgeton	Missouri
United States	Charleston Hematology Oncology Associates, Pa	Charleston	South Carolina
United States	Chattanooga Oncology Hematology Associates	Chattanooga	Tennessee
United States	Oncology Hematology Care, Inc.	Cincinnati	Ohio
United States	Louis Stokes Cleveland VA Medical Center	Cleveland	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Maryland Oncology Hematology, P.A.	Columbia	Maryland
United States	Mid Ohio Oncology Hematology	Columbus	Ohio
United States	Texas Oncology	Dallas	Texas
United States	Texas Oncology	Dallas	Texas
United States	Texas Oncology, P.A.	Dallas	Texas
United States	Texas Oncology/Methodist Charlton Cancer Ctr	Dallas	Texas
United States	Texas Oncology	Denton	Texas
United States	Bay Hematology Oncology	Easton	Maryland
United States	Minnesota Oncology Hematology, P.A.	Edina	Minnesota
United States	Texas Oncology	El Paso	Texas
United States	Erie Regional Cancer Center	Erie	Pennsylvania
United States	Oncology Associates Of Oregon, Pc	Eugene	Oregon
United States	Providence Regional Cancer Partnership	Everett	Washington
United States	Virginia Cancer Specialists, Pc	Fairfax	Virginia
United States	Sanford Health	Fargo	North Dakota
United States	San Juan Oncology Associates	Farmington	New Mexico
United States	Hunterdon Medical Center	Flemington	New Jersey
United States	Texas Oncology	Flower Mound	Texas
United States	Florida Cancer Specialists S.	Fort Myers	Florida
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Ft. Wayne Med Onco-Hema Inc	Fort Wayne	Indiana
United States	Texas Oncology	Fort Worth	Texas
United States	The Center For Cancer And Blood Disorders	Fort Worth	Texas
United States	St. Joseph Heritage Medical Group	Fullerton	California
United States	University of Florida at Shands	Gainesville	Florida
United States	The Jones Clinic, PC	Germantown	Tennessee
United States	West Cancer Center	Germantown	Tennessee
United States	Arizona Oncology Assoc, Pc-Hal	Glendale	Arizona
United States	Glens Falls Hospital	Glens Falls	New York
United States	St. Mary's Hospital Regional Cancer Center	Grand Junction	Colorado
United States	Cancer & Hematology Centers Of Western Michigan	Grand Rapids	Michigan
United States	Cone Health Cancer Center	Greensboro	North Carolina
United States	Moses Cone Health System	Greensboro	North Carolina
United States	Randolph Cancer Center	Greensboro	North Carolina
United States	Greenville Health System	Greenville	South Carolina
United States	Forrest General Cancer Center	Hattiesburg	Mississippi
United States	Memorial Cancer Institute	Hollywood	Florida
United States	Abington Hematology Oncology Associates, Inc	Horsham	Pennsylvania
United States	MD Anderson Cancer Center	Houston	Texas
United States	Texas Oncology	Houston	Texas
United States	Edwards Comprehensive Cancer Center	Huntington	West Virginia
United States	Jackson Oncology Associates, Pllc	Jackson	Mississippi
United States	Broome Oncology	Johnson City	New York
United States	Scripps Cancer Center	La Jolla	California
United States	Rocky Mountain Cancer Centers	Lakewood	Colorado
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Southeast Nebraska Cancer Center	Lincoln	Nebraska
United States	UCLA Hematology/Oncology Clinic	Los Angeles	California
United States	Hematology Oncology Associates	Medford	Oregon
United States	Texas Cancer Center Of Mesquite	Mesquite	Texas
United States	East Jefferson General Hospital	Metairie	Louisiana
United States	Baptist Health Medical Group Oncology	Miami	Florida
United States	Texas Oncology, Pa	Midland	Texas
United States	Southern Cancer Center Pc	Mobile	Alabama
United States	Summit Medical Group	Morristown	New Jersey
United States	Northern Westchester Hospital	Mount Kisco	New York
United States	Tennessee Oncology, PLLC - SCRI - PPDS	Nashville	Tennessee
United States	Texas Oncology	New Braunfels	Texas
United States	Columbia University Medical Center (Cumc)	New York	New York
United States	Cancer Treatment Centers Of America	Newnan	Georgia
United States	Illinois Cancer Specialists	Niles	Illinois
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Eastern Ct Hem Onc Assoc	Norwich	Connecticut
United States	Hematology-Oncology Associates Of Rockland	Nyack	New York
United States	Ocala Oncology Center	Ocala	Florida
United States	Nebraska Cancer Specialists	Omaha	Nebraska
United States	West KY Hematology Oncology Group PSC	Paducah	Kentucky
United States	Texas Oncology	Paris	Texas
United States	First Health Of The Carolinas	Pinehurst	North Carolina
United States	Texas Oncology Plano West Cancer Center	Plano	Texas
United States	Texas Oncology-Plano East	Plano	Texas
United States	Hematology Oncology Associates Of The Treasure Coast	Port Saint Lucie	Florida
United States	Virginia Cancer Institute	Richmond	Virginia
United States	Florida Cancer Specialists	Saint Petersburg	Florida
United States	W.G. Bill Hefner VA Medical Center	Salisbury	North Carolina
United States	Cancer Centers of South Texas	San Antonio	Texas
United States	Coastal Integrative Cancer Care	San Luis Obispo	California
United States	Central Coast Med Oncology	Santa Maria	California
United States	Summit Cancer Care	Savannah	Georgia
United States	New England Cancer Specialists	Scarborough	Maine
United States	Northern Arizona Hematology & Oncology Associates	Sedona	Arizona
United States	Texas Cancer Center - Sherman	Sherman	Texas
United States	Sanford Research	Sioux Falls	South Dakota
United States	Local Institution	Solvang	California
United States	Cancer Care Northwest	Spokane Valley	Washington
United States	Stamford Hospital	Stamford	Connecticut
United States	Texas Oncology Cancer Center - Sugar Land	Sugar Land	Texas
United States	Atlantic Health System	Summit	New Jersey
United States	Morristown Medical Center	Summit	New Jersey
United States	Tallahassee Memorial Cancer Center	Tallahassee	Florida
United States	Lewis Hall Singletary Oncology Center	Thomasville	Georgia
United States	Cotton-O-Neil Clinical Research Center	Topeka	Kansas
United States	Florida Cancer Affiliates	Trinity	Florida
United States	Arizona Clinical Research Center, Inc.	Tucson	Arizona
United States	Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope	Tucson	Arizona
United States	Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research	Tulsa	Oklahoma
United States	Texas Oncology-Tyler	Tyler	Texas
United States	Northwest Cancer Specialists, Pc	Vancouver	Washington
United States	Texas Oncology Cancer Care And Research Center	Waco	Texas
United States	Texas Oncology, P.A.	Webster	Texas
United States	Texas Oncology	Weslaco	Texas
United States	Va Ct Healthcare System	West Haven	Connecticut
United States	White Plains Hospital	White Plains	New York
United States	Texas Oncology-Wichita Falls	Wichita Falls	Texas
United States	Shenandoah Oncology	Winchester	Virginia
United States	Yakima Valley Memorial Hospital/North Star Lodge	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to approximately 48 months
Primary	Overall Survival (OS), Groups A-C Only	Overall survival (OS) is defined as the time from randomization to the date of death.	up to approximately 60 months
Primary	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.	up to approximately 60 months
Secondary	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.	up to approximately 48 months
Secondary	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.	up to approximately 48 months
Secondary	Overall Survival (OS), Group D Only	Overall survival (OS) is defined as the time from randomization to the date of death.	up to approximately 60 months
Secondary	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.	up to approximately 48 months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls