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A Study of Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Second-Line Nivolumab Monotherapy in Asia (CheckMate870)

Primary Purpose

Lung Cancer, Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Inclusion Criteria:

  • Advanced metastatic stage IIIB/IV NSCLC (Nonsquamous and squamous)
  • 1 to 2 prior systemic therapies
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 1
  • Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
  • Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to starting study treatment

Exclusion Criteria:

  • Women with a positive pregnancy test at enrollment or prior to administration of study medication
  • Participants with active central nervous system metastases
  • Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of study drug
  • Participants with previous malignancies are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required or anticipated to be required during the study period
  • Participants with carcinomatous meningitis

Other protocol defined inclusion/exclusion criteria could apply

Sites / Locations

  • Local Institution
  • Local Institution
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  • Local Institution
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  • Local Institution
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  • Local Institution
  • Local Institution
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  • Local Institution
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  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
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  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Monotherapy

Arm Description

Nivolumab administered every two weeks

Outcomes

Primary Outcome Measures

Incidence of high grade treatment-related select adverse events in non-hepatitis B virus (HBV) infected participants
Measured by number of incidences
Severity of high grade treatment-related select adverse events in non-HBV infected participants
Measured by National Cancer Institute- Common Terminology Criteria for Adverse Events version 4 (NCI-CTCAE v4)

Secondary Outcome Measures

Incidence of high grade treatment-related select adverse events in HBV infected participants
Measured by number of incidences
Severity of high grade treatment-related select adverse events in HBV infected participants
Measured by National Cancer Institute- Common Terminology Criteria for Adverse Events version 4 (NCI-CTCAE v4)
Laboratory test abnormalities
Measured by laboratory test parameters
Incidence of adverse events in all treated patients
Measured by number of incidences
Severity of adverse events in all treated patients
Measured by National Cancer Institute- Common Terminology Criteria for Adverse Events version 4 (NCI-CTCAE v4)

Full Information

First Posted
June 20, 2017
Last Updated
September 24, 2021
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03195491
Brief Title
A Study of Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Second-Line Nivolumab Monotherapy in Asia
Acronym
CheckMate870
Official Title
An Open Label, Safety Study of Participants With Non-Small Cell Lung Cancer Receiving Second-Line Nivolumab Monotherapy in Asia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 25, 2017 (Actual)
Primary Completion Date
June 8, 2021 (Actual)
Study Completion Date
June 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the safety of patients in Asia with Non-Small Cell Lung Cancer (NSCLC)who are treated with Nivolumab monotherapy as a second line or third line treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monotherapy
Arm Type
Experimental
Arm Description
Nivolumab administered every two weeks
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo, BMS-936558
Intervention Description
Intravenous infusion administered over 30 minutes at 240 mg
Primary Outcome Measure Information:
Title
Incidence of high grade treatment-related select adverse events in non-hepatitis B virus (HBV) infected participants
Description
Measured by number of incidences
Time Frame
Approximately 2 years
Title
Severity of high grade treatment-related select adverse events in non-HBV infected participants
Description
Measured by National Cancer Institute- Common Terminology Criteria for Adverse Events version 4 (NCI-CTCAE v4)
Time Frame
Approximately 2 years
Secondary Outcome Measure Information:
Title
Incidence of high grade treatment-related select adverse events in HBV infected participants
Description
Measured by number of incidences
Time Frame
Approximately 2 years
Title
Severity of high grade treatment-related select adverse events in HBV infected participants
Description
Measured by National Cancer Institute- Common Terminology Criteria for Adverse Events version 4 (NCI-CTCAE v4)
Time Frame
Approximately 2 years
Title
Laboratory test abnormalities
Description
Measured by laboratory test parameters
Time Frame
Approximately 2 years
Title
Incidence of adverse events in all treated patients
Description
Measured by number of incidences
Time Frame
Approximately 2 years
Title
Severity of adverse events in all treated patients
Description
Measured by National Cancer Institute- Common Terminology Criteria for Adverse Events version 4 (NCI-CTCAE v4)
Time Frame
Approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Advanced metastatic stage IIIB/IV NSCLC (Nonsquamous and squamous) 1 to 2 prior systemic therapies Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 1 Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to starting study treatment Exclusion Criteria: Women with a positive pregnancy test at enrollment or prior to administration of study medication Participants with active central nervous system metastases Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of study drug Participants with previous malignancies are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required or anticipated to be required during the study period Participants with carcinomatous meningitis Other protocol defined inclusion/exclusion criteria could apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100001
Country
China
Facility Name
Local Institution
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Local Institution
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Local Institution
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101149
Country
China
Facility Name
Local Institution
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
Local Institution
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Local Institution
City
Beijing
State/Province
Hebei
ZIP/Postal Code
100031
Country
China
Facility Name
Local Institution
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Local Institution
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Local Institution
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Local Institution
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Local Institution
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Local Institution
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
Local Institution
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
Local Institution
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Local Institution
City
Xi'an
State/Province
Shan3xi
ZIP/Postal Code
710038
Country
China
Facility Name
Local Institution
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250031
Country
China
Facility Name
Local Institution
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Local Institution
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Local Institution
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300222
Country
China
Facility Name
Local Institution
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830011
Country
China
Facility Name
Local Institution
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Name
Local Institution
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Local Institution
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Local Institution
City
Guangzhou
Country
China
Facility Name
Local Institution
City
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Local Institution
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Local Institution
City
Shenyang
ZIP/Postal Code
110042
Country
China
Facility Name
Local Institution
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Local Institution
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

A Study of Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Second-Line Nivolumab Monotherapy in Asia

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