Overview

This trial is active, not recruiting.

Condition small cell lung carcinoma
Treatments ipilimumab, placebo matching ipilimumab, etoposide, cisplatin, carboplatin
Phase phase 3
Target CTLA-4
Sponsor Bristol-Myers Squibb
Start date December 2011
End date March 2015
Trial size 1125 participants
Trial identifier NCT01450761, 2011-000850-48, CA184-156

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Ipilimumab: IV solution, Intravenous (IV), 10 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
ipilimumab Yervoy
etoposide Etopophos
cisplatin Platinol
carboplatin Paraplatin
(Placebo Comparator)
Placebo matching Ipilimumab: IV solution, IV, 0 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
placebo matching ipilimumab
etoposide Etopophos
cisplatin Platinol
carboplatin Paraplatin

Primary Outcomes

Measure
Overall Survival among subjects who receive at least one dose of blinded study therapy
time frame: Approximately 41 months after the 1st subject is randomized

Secondary Outcomes

Measure
Overall Survival in all Randomized Subjects
time frame: Approximately 41 months after the 1st subject is randomized
Progression Free Survival per mWHO in subjects who have received at least one dose of blinded study therapy
time frame: Approximately 41 months after the 1st subject is randomized

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab Plus Etoposide/Platinum Versus Etoposide/Platinum in Subjects With Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.
Location data was received from the National Cancer Institute and was last updated in June 2016.