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

Conditions

• Small Cell Lung Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ipilimumab — BIOLOGICAL
• Placebo matching Ipilimumab — BIOLOGICAL
• Etoposide — DRUG
• Cisplatin — DRUG
• Carboplatin — DRUG

Study Details

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.

Key Dates

Start date

Dec 13, 2011

Status verified

Jul 2020

Primary completion

Mar 19, 2015

Completion

May 17, 2017

Study Design

Enrollment

1,351 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ipilimumab+Etoposide+Cisplatin/Carboplatin
  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
• Placebo Comparator: Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin
  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

Primary Outcome Measure

Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy [ Time Frame: Randomization until date of death, up to March 2015, approximately 38 months ]

Locations (42)

Find similar trials in Hot Springs, AR

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