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) (CheckMate 592)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Biological: Nivolumab; Biological: Ipilimumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03001882

2018-000462-11 (EudraCT Number)

CA209-592

Details and patient eligibility

About

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).

Enrollment: 230 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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230 participants in 1 patient group

Combination therapy

Experimental group

Description:

Nivolumab + Ipilimumab

Treatment:

Biological: Ipilimumab

Biological: Nivolumab