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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01450761
First Posted: October 12, 2011
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]
    Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.


Secondary Outcome Measures:
  • Overall Survival in All Randomized Participants [ Time Frame: From randomization until date of death, up to March 2015, approximately 38 months ]
    Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.

  • Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy [ Time Frame: From randomization until disease progression, up to March 2015, approximately 38 months ]
    Progression-Free Survival was defined as the time from the date of randomization to the date of progression per modified World Health Organization (mWHO) criteria or death, whichever occured first. A participant who died without reported progression per mWHO criteria was considered progressed on the date of death. For those participants who remained alive and did not progress, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.


Enrollment: 1414
Actual Study Start Date: December 2011
Study Completion Date: May 17, 2017
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016
Drug: Etoposide
Other Names:
  • Etopophos
  • Neoposid
  • Eposin
Drug: Cisplatin
Other Name: Platinol
Drug: Carboplatin
Other Name: Paraplatin
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

Biological: Placebo matching Ipilimumab Drug: Etoposide
Other Names:
  • Etopophos
  • Neoposid
  • Eposin
Drug: Cisplatin
Other Name: Platinol
Drug: Carboplatin
Other Name: Paraplatin

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01450761


  Show 197 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01450761     History of Changes
Other Study ID Numbers: CA184-156
2011-000850-48 ( EudraCT Number )
First Submitted: October 10, 2011
First Posted: October 12, 2011
Results First Submitted: March 7, 2016
Results First Posted: July 18, 2016
Last Update Posted: July 11, 2017
Last Verified: June 2016

Additional relevant MeSH terms:
Small Cell Lung Carcinoma
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Etoposide phosphate
Cisplatin
Carboplatin
Etoposide
Antibodies, Monoclonal
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs