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

Purpose

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.

Condition	Intervention	Phase
Small Cell Lung Carcinoma	Biological: Ipilimumab Biological: Placebo matching Ipilimumab Drug: Etoposide Drug: Cisplatin Drug: Carboplatin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Etoposide Carboplatin Etoposide phosphate Ipilimumab

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Overall Survival [ Time Frame: Approximately 40.8 months after the first subject is randomized ] [ Designated as safety issue: No ]
After 816 Death Events have been observed (Interim analysis after 612 death events)

Secondary Outcome Measures:

Overall Survival (OS) of subjects who received blinded study therapy [ Time Frame: Approximately 40.8 months after the first subject is randomized ] [ Designated as safety issue: No ]
After 816 death events have been observed (analyses will be performed at the same time as the Primary Analysis)
Immune-related Progression Free Survival (irPFS) [ Time Frame: Approximately 40.8 months after the first subject is randomized ] [ Designated as safety issue: No ]
After 816 death events have been observed (analyses will be performed at the same time as the Primary Analysis)
Progression Free Survival [using Modified World Health Organization (mWHO) criteria] [ Time Frame: Approximately 40.8 months after the first subject is randomized ] [ Designated as safety issue: No ]
After 816 death events have been observed (analyses will be performed at the same time as the Primary Analysis)
Best Overall Response Rate by mWHO (BORR) [ Time Frame: Approximately 40.8 months after the first subject is randomized ] [ Designated as safety issue: No ]
After 816 death events have been observed (analyses will be performed at the same time as the Primary Analysis)
Duration of Response by mWHO (DoR) [ Time Frame: Approximately 40.8 months after the first subject is randomized ] [ Designated as safety issue: No ]
After 816 death events have been observed (analyses will be performed at the same time as the Primary Analysis)

Estimated Enrollment:	1100
Study Start Date:	January 2012
Estimated Study Completion Date:	March 2017
Estimated Primary Completion Date:	May 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ipilimumab+Etoposide+Cisplatin/Carboplatin	Biological: 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 Other Names: Yervoy BMS-734016 Drug: Etoposide IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Other Names: Etopophos Neoposid Eposin Drug: Cisplatin IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Other Name: Platinol Drug: Carboplatin IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses Other Name: Paraplatin
Placebo Comparator: Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin	Biological: 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 Drug: Etoposide IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Other Names: Etopophos Neoposid Eposin Drug: Cisplatin IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Other Name: Platinol Drug: Carboplatin IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses Other Name: Paraplatin

Arms

Assigned Interventions

Experimental: Ipilimumab+Etoposide+Cisplatin/Carboplatin

Biological: 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

Other Names:

Yervoy
BMS-734016

Drug: Etoposide

IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles

Other Names:

Etopophos
Neoposid
Eposin

Drug: Cisplatin

IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses

Other Name: Platinol

Drug: Carboplatin

IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses

Other Name: Paraplatin

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

Biological: 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

Drug: Etoposide

IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles

Other Names:

Etopophos
Neoposid
Eposin

Drug: Cisplatin

IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses

Other Name: Platinol

Drug: Carboplatin

IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses

Other Name: Paraplatin

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450761

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 117 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trial Information This link exits the ClinicalTrials.gov site

BMS clinical trial educational resource This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01450761 History of Changes
Other Study ID Numbers:	CA184-156, 2011-000850-48
Study First Received:	October 10, 2011
Last Updated:	May 9, 2013
Health Authority:	United States: Food and Drug Administration Hong Kong: Department of Health Singapore: Clinical Trials & Epidemiology Research Unit (CTERU) South Korea: Korea Food and Drug Administration (KFDA) Taiwan: Department of Health Thailand: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Health Canada Czech Republic: State Institute for Drug Control Hungary: National Institute of Pharmacy Poland: National Institute of Medicines Romania: National Medicines Agency Russia: Ethics Committee Russia: Ministry of Health of the Russian Federation Austria: Federal Office for Safety in Health Care Germany: Federal Institute for Drugs and Medical Devices Switzerland: Federal Office of Public Health France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) South Africa: Medicines Control Council Portugal: National Pharmacy and Medicines Institute Spain: Spanish Agency of Medicines Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Brazil: National Health Surveillance Agency Chile: CONEP Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Peru: Instituto Nacional de Salud Mexico: Federal Commission for Sanitary Risks Protection Denmark: Data inspectorate, Directorate for Health and Social Affairs Finland: Finnish Medicines Agency Norway: Directorate of Health Sweden: Medical Products Agency Israel: Israeli Health Ministry Pharmaceutical Administration Italy: Ministry of Health Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Carcinoma
Lung Neoplasms
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic

Bronchial Neoplasms
Etoposide phosphate
Cisplatin
Etoposide
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on June 17, 2013