A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC

Completed · Phase 3

Conditions studied: Non-Small Cell Lung Cancer

In brief

The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease

Key facts

Study ID

NCT03215706

Run by

Bristol-Myers Squibb

People needed

719

Starts

2017-08-24

Expected to finish

2024-10-18

Last updated by the study team

2025-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
• Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
• Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria
• Participants must have PD-L1 IHC testing with results performed by a central laboratory during the screening period

You may not qualify if…

• Participants with known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution mutations) are excluded
• Participants with known anaplastic lymphoma kinase (ALK) translocations which are sensitive to available targeted inhibitor therapy are excluded
• Participants with untreated CNS metastases are excluded. Participants are eligible if CNS metastases are adequately treated and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first treatment
• Other protocol inclusion/exclusion criteria may apply

Where it is running

• Local Institution - 0044 — Plainville, Connecticut, United States
• Local Institution - 0045 — Jacksonville, Florida, United States
• Local Institution - 0029 — Marietta, Georgia, United States
• Local Institution - 0091 — Wichita, Kansas, United States
• Local Institution - 0004 — Lexington, Kentucky, United States
• Local Institution - 0105 — Detroit, Michigan, United States
• Local Institution - 0058 — Johnson City, New York, United States
• Local Institution - 0098 — Mineola, New York, United States
• Local Institution - 0095 — Columbus, Ohio, United States
• Local Institution - 0006 — Lancaster, Pennsylvania, United States
• Local Institution - 0047 — Pittsburgh, Pennsylvania, United States
• Local Institution - 0093 — Pittsburgh, Pennsylvania, United States
• Local Institution - 0094 — Charleston, South Carolina, United States
• Southwest Regional Cancer Clinic — St. George, Utah, United States
• Local Institution - 0099 — Madison, Wisconsin, United States
• Local Institution - 0014 — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
• Local Institution - 0028 — Río Cuarto, Córdoba Province, Argentina
• Local Institution - 0026 — Viedma, Río Negro Province, Argentina
• Local Institution - 0027 — Rosario, Santa Fe Province, Argentina
• Local Institution - 0030 — Córdoba, Argentina
• Local Institution - 0086 — Gosford, New South Wales, Australia
• Local Institution - 0040 — Bedford Park, South Australia, Australia
• Local Institution - 0089 — Box Hill, Victoria, Australia
• Local Institution - 0036 — Heidelberg, Victoria, Australia
• Memorial Health Systems — Colorado Springs, Colorado, United States

Full record on ClinicalTrials.gov

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