Phase 3 N=1,132 Randomized Quadruple-blind Treatment

Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone

Small Cell Lung Carcinoma

Bottom Line

View on ClinicalTrials.gov: NCT01450761 ↗

Enrolled (actual)

1,132

Serious AEs

52.9%

Results posted

Jul 2016

Primary outcome: Primary: Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy — 10.97; 10.94 months — p=0.3775

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ipilimumab (Biological); Placebo matching Ipilimumab (Biological); Etoposide (Drug); Cisplatin (Drug); Carboplatin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy	10.97; 10.94	0.3775
SECONDARY Overall Survival in All Randomized Participants	10.22; 9.95	0.5678
SECONDARY Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy	4.63; 4.44	0.0161 sig

Summary

The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone.

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria

Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)
Eastern Cooperative Oncology Group (ECOG) of 0 or 1

Exclusion Criteria

Prior systemic therapy for lung cancer
Symptomatic Central Nervous System (CNS) metastases
History of autoimmune disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01450761). 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.