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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

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ClinicalTrials.gov Identifier: NCT01450761
Recruitment Status : Completed
First Posted : October 12, 2011
Results First Posted : July 18, 2016
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE October 10, 2011
First Posted Date  ICMJE October 12, 2011
Results First Submitted Date  ICMJE March 7, 2016
Results First Posted Date  ICMJE July 18, 2016
Last Update Posted Date July 8, 2020
Actual Study Start Date  ICMJE December 13, 2011
Actual Primary Completion Date March 19, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 11, 2011)
Overall Survival [ Time Frame: Approximately 40.8 months after the first subject is randomized ]
After 816 Death Events have been observed (Interim analysis after 612 death events)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2011)
  • Overall Survival (OS) of subjects who received blinded study therapy [ Time Frame: Approximately 40.8 months after the first subject is randomized ]
    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 ]
    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 ]
    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 ]
    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 ]
    After 816 death events have been observed (analyses will be performed at the same time as the Primary Analysis)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Small Cell Lung Carcinoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Reck M, Luft A, Szczesna A, Havel L, Kim SW, Akerley W, Pietanza MC, Wu YL, Zielinski C, Thomas M, Felip E, Gold K, Horn L, Aerts J, Nakagawa K, Lorigan P, Pieters A, Kong Sanchez T, Fairchild J, Spigel D. Phase III Randomized Trial of Ipilimumab Plus Etoposide and Platinum Versus Placebo Plus Etoposide and Platinum in Extensive-Stage Small-Cell Lung Cancer. J Clin Oncol. 2016 Nov 1;34(31):3740-3748. doi: 10.1200/JCO.2016.67.6601. Erratum in: J Clin Oncol. 2019 Dec 1;37(34):3327.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 17, 2018)
1351
Original Estimated Enrollment  ICMJE
 (submitted: October 11, 2011)
912
Actual Study Completion Date  ICMJE May 17, 2017
Actual Primary Completion Date March 19, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   China,   Colombia,   Czechia,   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,   United States
Removed Location Countries Czech Republic,   Finland
 
Administrative Information
NCT Number  ICMJE NCT01450761
Other Study ID Numbers  ICMJE CA184-156
2011-000850-48 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date July 2020

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