Phase 3 N=569 Randomized Treatment

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

Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02481830 ↗

Enrolled (actual)

569

Serious AEs

64.7%

Results posted

Jan 2020

Primary outcome: Primary: Overall Survival (OS) — 7.46; 8.38 Months — p=0.1144

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Nivolumab (Drug); Topotecan (Drug); Amrubicin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Aug 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Survival (OS)	7.46; 8.38	0.1144
SECONDARY Progression Free Survival (PFS)	1.45; 3.71	—
SECONDARY Objective Response Rate (ORR)	13.7; 16.8	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02481830). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.