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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) logo

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

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

Trial contacts and locations

225

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Data sourced from clinicaltrials.gov

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