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
Results First Received: May 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Lung Cancer - Non Small Cell (Squamous)
Interventions: Drug: Ipilimumab
Drug: Placebo
Drug: Paclitaxel
Drug: Carboplatin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1289 participants were enrolled and 956 were randomized (479 Ipilimumab, 477 Placebo). 948 were treated (475 Ipilimumab, 473 Placebo). Reasons for non-treatment is 4 no longer met study criteria, 2 adverse events unrelated to study drug, 1 participant request to discontinue, and 1 non-reported reason.

Reporting Groups
  Description
Ipilimumab With Paclitaxel/Carboplatin

Ipilimumab + Active Chemotherapy Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin).

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)

Active Chemo Backbone:

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

Placebo With Paclitaxel/Carboplatin

Placebo + Active Chemotherapy Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin).

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)

Active Chemotherapy Backbone:

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


Participant Flow for 2 periods

Period 1:   Randomized
    Ipilimumab With Paclitaxel/Carboplatin     Placebo With Paclitaxel/Carboplatin  
STARTED     479 [1]   477 [1]
Treated With Chemotherapy (1st Dose)     475     473  
COMPLETED     388     361  
NOT COMPLETED     91     116  
Progressive Disease                 41                 61  
Adverse Event Unrelated to Study Drug                 18                 18  
Study Drug Toxicity                 13                 14  
Death                 5                 7  
Withdrawal by Subject                 8                 11  
Subject No Longer Met Study Criteria                 1                 1  
Undisclosed Reasons                 1                 0  
Randomized but not Treated                 4                 4  
[1] Represents participants randomized to this arm prior to 1st dose of chemotherapy treatment

Period 2:   Treated With Blinded Therapy
    Ipilimumab With Paclitaxel/Carboplatin     Placebo With Paclitaxel/Carboplatin  
STARTED     388     361  
COMPLETED     9 [1]   8 [1]
NOT COMPLETED     379     353  
Progressive Disease                 220                 305  
Study Drug Toxicity                 87                 14  
Adverse Event Unrelated to Study Drug                 36                 14  
Withdrawal by Subject                 18                 7  
Death                 11                 3  
Maximum Clinical Benefit                 2                 4  
Not Reported                 4                 4  
Poor/Non-Compliance                 0                 2  
Subject No Longer Met Study Criteria                 1                 0  
[1] Completed = Still on Treatment



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized Participants Who Received at Least One Dose of Blinded Study Therapy

Reporting Groups
  Description
Ipilimumab With Paclitaxel/Carboplatin

Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin).

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)

Active Chemo Backbone:

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

Placebo With Paclitaxel/Carboplatin

Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin).

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)

Active Chemo Backbone:

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

Total Total of all reporting groups

Baseline Measures
    Ipilimumab With Paclitaxel/Carboplatin     Placebo With Paclitaxel/Carboplatin     Total  
Number of Participants  
[units: participants]
  388     361     749  
Age  
[units: years]
Mean (Standard Deviation)
  63.7  (8.27)     63.7  (8.70)     63.7  (8.47)  
Gender  
[units: participants]
     
Female     62     52     114  
Male     326     309     635  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     1     1  
Asian     106     108     214  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     3     3     6  
White     276     243     519  
More than one race     0     0     0  
Unknown or Not Reported     3     6     9  
Eastern Cooperative Oncology Group (ECOG) Performance Status [1]
[units: participants]
     
0     135     124     259  
1     251     234     485  
2     1     3     4  
3     1     0     1  
Disease Stage at Study Entry [2]
[units: participants]
     
Stage IV     367     333     700  
Recurrent     21     28     49  
[1] ECOG Performance Status is a 6-item scale used to assess disease progression, daily functioning, appropriate treatment, and prognosis. Performance status is scored on a scale ranging from 0-5, with (best score) 0=fully active and able to carry on all pre-disease performance without restriction and (worst score) 5=death.
[2] Non-Small Cell Lung Cancer is categorized in 4 Stages (I-IV). I: Cancer located only in lungs and has not spread to any lymph nodes. II: Cancer in the lung and nearby lymph nodes. III: Cancer in the lung and lymph nodes in the middle of the chest. Stage III has two subtypes, IIIA (cancer has spread only to lymph nodes on the same side of the chest where the cancer started) and IIIB (cancer has spread to the lymph nodes on the opposite side of the chest, or above the collar bone). IV: Cancer has spread to both lungs, to fluid in the area around the lungs, or to another part of the body.



  Outcome Measures
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1.  Primary:   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) ]

2.  Secondary:   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) ]

3.  Secondary:   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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com



Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01285609     History of Changes
Other Study ID Numbers: CA184-104
2009-017396-19 ( EudraCT Number )
Study First Received: January 24, 2011
Results First Received: May 16, 2016
Last Updated: June 22, 2016
Health Authority: United States: Food and Drug Administration
Hong Kong: Department of Health
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Thailand: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Poland: National Institute of Medicines
Romania: National Medicines Agency
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Austria: Federal Office for Safety in Health Care
Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Federal Office of Public Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
South Africa: Medicines Control Council
Portugal: National Pharmacy and Medicines Institute
Spain: Spanish Agency of Medicines
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Chile: CONEP
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Peru: Instituto Nacional de Salud
Mexico: Federal Commission for Sanitary Risks Protection
Denmark: Data inspectorate, Directorate for Health and Social Affairs
Finland: Finnish Medicines Agency
Norway: Directorate of Health
Sweden: Medical Products Agency
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ministry of Health
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency