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

An Open Label, Safety Study of Participants With Non-Small Cell Lung Cancer Receiving Second-Line Nivolumab Monotherapy in Asia

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.

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer; Lung Cancer
• Intervention / Treatment: Biological: Nivolumab

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • Local Institution
  • Shanghai, China, 200030
    • Local Institution
  • Shanghai, China, 200032
    • Local Institution
  • Shenyang, China, 110042
    • Local Institution
  • Beijing
    • Beijing, Beijing, China, 100730
      • Local Institution
    • Beijing, Beijing, China, 100001
      • Local Institution
    • Beijing, Beijing, China, 100142
      • Local Institution
    • Beijing, Beijing, China, 101149
      • Local Institution
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Local Institution
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Local Institution
  • Hebei
    • Beijing, Hebei, China, 100031
      • Local Institution
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Local Institution
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Local Institution
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Local Institution
  • Hunan
    • Changsha, Hunan, China, 410013
      • Local Institution
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Local Institution
    • Nanjing, Jiangsu, China, 210008
      • Local Institution
  • Jilin
    • Changchun, Jilin, China, 130012
      • Local Institution
    • Changchun, Jilin, China, 130021
      • Local Institution
  • Shan3xi
    • Xi'an, Shan3xi, China, 710038
      • Local Institution
  • Shandong
    • Jinan, Shandong, China, 250031
      • Local Institution
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Local Institution
    • Shanghai, Shanghai, China, 200032
      • Local Institution
  • Tianjin
    • Tianjin, Tianjin, China, 300222
      • Local Institution
  • Xinjiang
    • Urumqi, Xinjiang, China, 830011
      • Local Institution
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Local Institution
    • Hangzhou, Zhejiang, China, 310003
      • Local Institution
    • Hangzhou, Zhejiang, China, 310022
      • Local Institution
• Thailand
  • Bangkok, Thailand, 10700
    • Local Institution
  • Khon Kaen, Thailand, 40002
    • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monotherapy; Nivolumab administered every two weeks	Biological: Nivolumab; Intravenous infusion administered over 30 minutes at 240 mg; Other Names: BMS-936558; Opdivo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of high grade treatment-related select adverse events in non-hepatitis B virus (HBV) infected participants	Measured by number of incidences	Approximately 2 years
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)	Approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of high grade treatment-related select adverse events in HBV infected participants	Measured by number of incidences	Approximately 2 years
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)	Approximately 2 years
Laboratory test abnormalities	Measured by laboratory test parameters	Approximately 2 years
Incidence of adverse events in all treated patients	Measured by number of incidences	Approximately 2 years
Severity of adverse events in all treated patients	Measured by National Cancer Institute- Common Terminology Criteria for Adverse Events version 4 (NCI-CTCAE v4)	Approximately 2 years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2017
• Primary Completion (Actual): June 8, 2021
• Study Completion (Actual): June 8, 2021

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (Actual): June 22, 2017

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 24, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab
• Other Study ID Numbers: CA209-870

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No