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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNivolumab and Ipilimumab

Plus 1 other study approaches.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 5, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?197 U.S. locations

Locations may change over time.

Who runs it?Bristol-Myers Squibb

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 3
Sponsor: Bristol-Myers Squibb
Interventions being studied: Biological: Nivolumab; Biological: Ipilimumab; Other: Placebo

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Treatment approach

Immunotherapy→Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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

Reasons someone may not be able to joinExclusion criteria

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/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Local Institution - 0003Sacramento, California
Local Institution - 0202New Haven, Connecticut
Local Institution - 0127Fort Myers, Florida
Local Institution - 0007Jacksonville, Florida
Local Institution - 0128St. Petersburg, Florida
Local Institution - 0010Atlanta, Georgia
Local Institution - 0013Indianapolis, Indiana
Local Institution - 0061Fairway, Kansas
Local Institution - 0012Wichita, Kansas
Local Institution - 0032Lexington, Kentucky
Local Institution - 0051Baltimore, Maryland
Local Institution - 0107Boston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 5, 2023. Always confirm current availability with the study team.

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