Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer

Completed · Phase 3

Conditions studied: Lung Cancer

In brief

The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy in subjects with relapsed SCLC.

Key facts

Study ID

NCT02481830

Run by

Bristol-Myers Squibb

People needed

569

Starts

2015-09-14

Expected to finish

2022-08-30

Last updated by the study team

2023-07-27

Who can join

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

You may qualify if…

• Histologically or cytologically confirmed small cell lung cancer (SCLC)
• Subjects with either limited or extensive disease stage at the initial diagnosis
• Must have recurrence or progression after platinum-based first-line chemotherapy or chemoradiation therapy for the treatment of limited or extensive disease stage SCLC
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

You may not qualify if…

• Untreated or symptomatic central nervous system (CNS) metastases
• Prior therapy with anti-PD-1, anti-PDL1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody
• Inadequate hematologic or hepatic function

Where it is running

• Local Institution - 0024 — New Haven, Connecticut, United States
• Local Institution - 0018 — Atlanta, Georgia, United States
• Local Institution - 0056 — St Louis, Missouri, United States
• Local Institution - 0088 — Lincoln, Nebraska, United States
• Local Institution - 0173 — Johnson City, New York, United States
• Local Institution - 0001 — Durham, North Carolina, United States
• Local Institution - 0090 — Cleveland, Ohio, United States
• Local Institution - 0002 — Bethlehem, Pennsylvania, United States
• Local Institution - 0057 — Lancaster, Pennsylvania, United States
• Local Institution - 0053 — Philadelphia, Pennsylvania, United States
• Local Institution - 0089 — Nashville, Tennessee, United States
• Local Institution - 0009 — Nashville, Tennessee, United States
• Local Institution - 0070 — Kennewick, Washington, United States
• Local Institution - 0102 — Waratah, New South Wales, Australia
• Local Institution - 0030 — Brisbane, Queensland, Australia
• Local Institution - 0031 — Elizabeth Vale, South Australia, Australia
• Local Institution - 0103 — Kurralta Park, South Australia, Australia
• Local Institution - 0028 — Perth, Western Australia, Australia
• Local Institution - 0027 — Murdoch, Australia
• Local Institution - 0085 — Graz, Austria
• Local Institution - 0086 — Vienna, Austria
• Local Institution - 0084 — Wels, Austria
• Local Institution - 0013 — Brussels, Belgium
• Local Institution - 0012 — Edegem, Belgium
• Local Institution - 0065 — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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