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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01450761
First received: October 10, 2011
Last updated: June 7, 2016
Last verified: June 2016

October 10, 2011
June 7, 2016
December 2011
March 2015   (final data collection date for 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 ] [ Designated as safety issue: No ]
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.
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)
Complete list of historical versions of study NCT01450761 on ClinicalTrials.gov Archive Site
  • Overall Survival in All Randomized Participants [ Time Frame: From randomization until date of death, up to March 2015, approximately 38 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • 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)
Not Provided
Not Provided
 
Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone
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)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Small Cell Lung Carcinoma
  • Biological: Ipilimumab
    Other Names:
    • Yervoy
    • BMS-734016
  • Biological: Placebo matching Ipilimumab
  • Drug: Etoposide
    Other Names:
    • Etopophos
    • Neoposid
    • Eposin
  • Drug: Cisplatin
    Other Name: Platinol
  • Drug: Carboplatin
    Other Name: Paraplatin
  • 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

    Interventions:
    • Biological: Ipilimumab
    • Drug: Etoposide
    • Drug: Cisplatin
    • Drug: Carboplatin
  • 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

    Interventions:
    • Biological: Placebo matching Ipilimumab
    • Drug: Etoposide
    • Drug: Cisplatin
    • Drug: Carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1414
March 2017
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   China,   Colombia,   Czech Republic,   France,   Germany,   Hong Kong,   Hungary,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Peru,   Poland,   Portugal,   Romania,   Russian Federation,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   United Kingdom
Finland
 
NCT01450761
CA184-156, 2011-000850-48
Yes
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP