An Exploratory Study of the Effects of Nivolumab Combined With Ipilimumab in Patients With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Purpose

The purpose of this study is to explore the possible links between participant characteristics and their cancer, with how effective the combination of nivolumab with ipilimumab is, in participants with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC).

Condition

  • Non-Small Cell Lung Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Histologically confirmed, stage IV or recurrent non-small cell lung cancer with no prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease - Measurable disease by CT or MRI - Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work

Exclusion Criteria

  • Participants with untreated central nervous system metastases - Participants with active, known or suspected autoimmune disease - Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors) Other protocol defined inclusion/exclusion criteria apply

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Combination therapy 		Nivolumab + Ipilimumab
  • Biological: Nivolumab
    Specified dose on specified days
    Other names:
    • Opdivo
    • BMS-936558
  • Biological: Ipilimumab
    Specified dose on specified days
    Other names:
    • Yervoy
    • BMS-734016

More Details

Status
Completed
Sponsor
Bristol-Myers Squibb

Study Contact