Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Plus Paclitaxel and Carboplatin Versus Placebo Plus Paclitaxel and Carboplatin

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01285609
First received: January 24, 2011
Last updated: June 12, 2014
Last verified: June 2014

January 24, 2011
June 12, 2014
January 2011
October 2015   (final data collection date for primary outcome measure)
Overall Survival (OS) in Subjects who have received at least one dose of blinded study therapy [ Time Frame: Approximately 48 months post study start ] [ Designated as safety issue: No ]

Analysis will be conducted when the following 2 conditions have both been met:

  1. 518 OS events have been observed in randomized subjects treated with at least one dose of blinded study therapy and
  2. 705 OS events have been observed in all randomized subjects
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 in all Randomized Subjects [ Time Frame: Approximately 42 months post study start ] [ Designated as safety issue: No ]
  • Progression Free Survival per mWHO in subjects who have received at least one dose of blinded study therapy [ Time Frame: Approximately 42 months post study start ] [ Designated as safety issue: No ]
  • 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
 
Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Plus Paclitaxel and Carboplatin Versus Placebo Plus 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.

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
Lung Cancer - Non Small Cell
  • 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.
 
Recruiting
920
December 2016
October 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) of 0 or 1

Exclusion Criteria:

  • Brain Metastases
  • Autoimmune diseases
Both
18 Years and older
No
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   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
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2014

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