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Small Cell Lung Carcinoma | 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 research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Small Cell Lung Carcinoma

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Biological:Ipilimumab

Biological:Placebo matching Ipilimumab

Drug:Etoposide

Drug:Cisplatin

Drug:Carboplatin

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Ipilimumab+Etoposide+Cisplatin/CarboplatinIpilimumab: 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

Placebo matching Ipilimumab+Etoposide+Cisplatin/CarboplatinPlacebo 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

Study Status

Completed

Start Date: December 13, 2011

Completed Date: May 17, 2017

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy

Secondary Outcome: Overall Survival in All Randomized Participants

Study sponsors, principal investigator, and references

Principal Investigator: Bristol-Myers Squibb

Lead Sponsor: Bristol-Myers Squibb

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01450761

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