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

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNivolumab and Topotecan

Plus 1 other study approaches.

Who it may be forSmall cell lung cancer (SCLC) · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 27, 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?151 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: Drug: Nivolumab; Drug: Topotecan; Drug: Amrubicin

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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)→

Disease setting

Recurrent or relapsed→

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

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

Reasons someone may not be able to joinExclusion criteria

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

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 - 0065Little Rock, Arkansas
Local Institution - 0024New Haven, Connecticut
Local Institution - 0018Atlanta, Georgia
Local Institution - 0056St Louis, Missouri
Local Institution - 0088Lincoln, Nebraska
Local Institution - 0173Johnson City, New York
Local Institution - 0001Durham, North Carolina
Local Institution - 0090Cleveland, Ohio
Local Institution - 0002Bethlehem, Pennsylvania
Local Institution - 0057Lancaster, Pennsylvania
Local Institution - 0053Philadelphia, Pennsylvania
Local Institution - 0089Nashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 27, 2023. Always confirm current availability with the study team.

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