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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Small Cell Lung Carcinoma

Treatments: Drug: Cisplatin; Biological: Placebo matching Ipilimumab; Drug: Carboplatin; Drug: Etoposide; Biological: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01450761

2011-000850-48 (EudraCT Number)

CA184-156

Details and patient eligibility

About

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.

Enrollment: 1,351 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,351 participants in 2 patient groups, including a placebo group

Ipilimumab+Etoposide+Cisplatin/Carboplatin

Experimental group

Description:

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

Treatment:

Biological: Ipilimumab

Drug: Carboplatin

Drug: Etoposide

Drug: Cisplatin

Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo matching Ipilimumab

Drug: Carboplatin

Drug: Etoposide

Drug: Cisplatin