An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy

Completed · Phase 3 · Has a placebo group

Conditions studied: Lung Cancer

In brief

In this study, all patients must have already completed first-line chemotherapy to treat extensive-stage disease small cell lung cancer. The purpose of this study is to show that nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall survival when administered as consolidation treatment in patients that are stable or responding after chemotherapy. Patients receiving treatment will be compared with patients taking placebo.

Key facts

Study ID

NCT02538666

Run by

Bristol-Myers Squibb

People needed

907

Starts

2015-10-13

Expected to finish

2021-11-11

Last updated by the study team

2023-01-05

Who can join

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

You may qualify if…

• Subjects with histologically or cytologically confirmed extensive stage disease SCLC
• Ongoing response of stable disease or better following 4 cycles of platinum-based first line chemotherapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

You may not qualify if…

• Subjects with symptomatic Central Nervous System (CNS) metastases
• Subjects receiving consolidative chest radiation
• Subjects with active, known, or suspected autoimmune disease are excluded
• All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 0202 — New Haven, Connecticut, United States
• Local Institution - 0127 — Fort Myers, Florida, United States
• Local Institution - 0007 — Jacksonville, Florida, United States
• Local Institution - 0128 — St. Petersburg, Florida, United States
• Local Institution - 0010 — Atlanta, Georgia, United States
• Local Institution - 0013 — Indianapolis, Indiana, United States
• Local Institution - 0061 — Fairway, Kansas, United States
• Local Institution - 0012 — Wichita, Kansas, United States
• Local Institution - 0032 — Lexington, Kentucky, United States
• Local Institution - 0051 — Baltimore, Maryland, United States
• Local Institution - 0107 — Boston, Massachusetts, United States
• Local Institution - 0207 — Boston, Massachusetts, United States
• Local Institution - 0015 — St Louis, Missouri, United States
• Local Institution - 0008 — New York, New York, United States
• Local Institution - 0014 — Durham, North Carolina, United States
• Local Institution - 0016 — Winston-Salem, North Carolina, United States
• Local Institution - 0215 — Fargo, North Dakota, United States
• Local Institution - 0129 — Cincinnati, Ohio, United States
• Local Institution - 0009 — Columbus, Ohio, United States
• Local Institution - 0001 — Portland, Oregon, United States
• Local Institution - 0034 — Portland, Oregon, United States
• Local Institution - 0004 — Allentown, Pennsylvania, United States
• Local Institution - 0002 — Sayre, Pennsylvania, United States
• Local Institution - 0005 — Charleston, South Carolina, United States
• Local Institution - 0003 — Sacramento, California, United States

Full record on ClinicalTrials.gov

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