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

Purpose

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.

Condition	Intervention	Phase
Lung Cancer - Non Small Cell (Squamous)	Drug: Ipilimumab Drug: Placebo Drug: Paclitaxel Drug: Carboplatin	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Treatment
Official Title:	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)

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

Drug Information available for: Paclitaxel Carboplatin Ipilimumab

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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) ]
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.

Secondary Outcome Measures:

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) ]
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) ]
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.


Enrollment:	1289
Study Start Date:	August 2011
Estimated Study Completion Date:	March 2017
Primary Completion Date:	June 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	Drug: Ipilimumab Other Name: BMS-734016 Drug: Paclitaxel Other Name: Taxol® Drug: Carboplatin Other Name: Paraplatin®
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	Drug: Placebo Drug: Paclitaxel Other Name: Taxol® Drug: Carboplatin Other Name: Paraplatin®

Arms

Assigned Interventions

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

Drug: Ipilimumab

Other Name: BMS-734016

Drug: Paclitaxel

Other Name: Taxol®

Drug: Carboplatin

Other Name: Paraplatin®

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

Drug: Placebo Drug: Paclitaxel

Other Name: Taxol®

Drug: Carboplatin

Other Name: Paraplatin®

Detailed Description:

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).

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285609

Show 279 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trial Information This link exits the ClinicalTrials.gov site

BMS clinical trial educational resource This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site


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:	January 31, 2017


Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:


Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Paclitaxel	Albumin-Bound Paclitaxel Carboplatin Antibodies, Monoclonal Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 27, 2017