Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01285609
First received: January 24, 2011
Last updated: June 22, 2016
Last verified: June 2016

January 24, 2011
June 22, 2016
August 2011
June 2015   (final data collection date for primary outcome measure)
Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint [ Time Frame: Randomization until 518 deaths, up to June 2015 (approximately 48 months post study start) ] [ Designated as safety issue: No ]
Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
Overall Survival (defined as the time from the date of randomization until the date of death or the last known date the subject was alive) [ Time Frame: Until 516 Death Events have occurred ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01285609 on ClinicalTrials.gov Archive Site
  • Overall Survival (OS) in All Randomized Participants at Primary Endpoint [ Time Frame: Randomization until 705 deaths, up to June 2015 (approximately 48 months post study start) ] [ Designated as safety issue: No ]
    Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
  • Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint [ Time Frame: Randomization until 518 deaths, up to June 2015 (approximately 48 months post study start) ] [ Designated as safety issue: No ]
    Progression-free survival (PFS) is defined as the time between the date of randomization and the date of tumor progression per Modified World Health Organization (mWHO) criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria were considered to have progressed on the date of death. For participants who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. For participants who remain alive and have no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.
  • Progression Free Survival (determined as the time between the date of randomization and the date of progression per mWHO criteria) [ Time Frame: Approximately 39 months post study start ] [ Designated as safety issue: No ]
  • Best Overall Response Rate (determined by the number of subjects who are complete or partial responders divided by the total number of subjects in the data set) [ Time Frame: Approximately 39 months post study start ] [ Designated as safety issue: No ]
  • Time to Symptom Progression (defined as the time between the date of randomization and the date of dyspnea progression) [ Time Frame: Approximately 39 months post study start ] [ Designated as safety issue: No ]
  • Characterize Safety Profile (by tabulating all on-study adverse events (AEs), drug-related AEs, SAEs and drug-related SAEs) [ Time Frame: Approximately 39 months post study start ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin
Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non Small Cell Lung Cancer (NSCLC)
The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the lives of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.
The primary objective is to compare Overall Survival (OS) of participants with Stage IV/recurrent NSCLC of squamous histology who have been randomized to ipilimumab in addition to paclitaxel and carboplatin versus placebo in addition to paclitaxel and carboplatin, and have received at least one dose of blinded study therapy (ipilimumab or placebo).
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Lung Cancer - Non Small Cell (Squamous)
  • Drug: Ipilimumab
    Other Name: BMS-734016
  • Drug: Placebo
  • Drug: Paclitaxel
    Other Name: Taxol®
  • Drug: Carboplatin
    Other Name: Paraplatin®
  • Experimental: Ipilimumab + Paclitaxel and Carboplatin

    Ipilimumab + Active Chemo Backbone

    Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)

    Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses

    Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses

    Interventions:
    • Drug: Ipilimumab
    • Drug: Paclitaxel
    • Drug: Carboplatin
  • Placebo Comparator: Placebo + Paclitaxel and Carboplatin

    Placebo + Active Chemo Backbone

    Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)

    Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses

    Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses

    Interventions:
    • Drug: Placebo
    • Drug: Paclitaxel
    • 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
1289
December 2016
June 2015   (final data collection date for primary outcome measure)

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • Non small cell lung cancer (NSCLC) - squamous cell
  • Stage IV or recurrent NSCLC
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • Brain Metastases
  • Autoimmune diseases
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,   Denmark,   France,   Germany,   Hong Kong,   Hungary,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Peru,   Poland,   Portugal,   Romania,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   United Kingdom
 
NCT01285609
CA184-104, 2009-017396-19
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