UAMS - Translational Research Institute

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

Purpose

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

Condition

Lung Cancer

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Arm A Nivolumab	Nivolumab intravenous infusion as specified	Drug: Nivolumab
Active Comparator Arm B Chemotherapy Topotecan	Topotecan as specified	Drug: Topotecan
Active Comparator Arm B Chemotherapy Amrubicin	Amrubicin intravenous infusion as specified (upon investigator's choice, where locally approved for 2nd line SCLC treatment)	Drug: Amrubicin

Recruiting Locations

More Details

NCT ID: NCT02481830
Status: Completed
Sponsor: Bristol-Myers Squibb

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.