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CompletedPhase 3NCT02481830

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

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

Checked against the public recordLast updated Jul 27, 2023 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 3
U.S. locations151
SponsorBristol-Myers Squibb
01
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
02
Explore related studies

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→
03
Public criteria

Who may be able to participate

Inclusion 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 Exclusion 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.

04
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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