Safety and Efficacy Trial of Ipilimumab Versus Pemetrexed in Non-Squamous Non-Small Cell Lung Cancer

NCT ID: NCT01471197

Last Updated: 2014-05-12

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-02-28

Brief Summary

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The purpose of this trial is to determine whether Ipilimumab will prolong survival when compared to Pemetrexed in subjects with nonsquamous, non-small cell lung cancer.

Detailed Description

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Conditions

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Lung Cancer - Non Small Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: Ipilimumab

Group Type EXPERIMENTAL

Ipilimumab

Intervention Type BIOLOGICAL

Intravenous (IV) solution, IV, 10mg/kg, Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion

Arm 2: Pemetrexed

Group Type ACTIVE_COMPARATOR

Pemetrexed

Intervention Type BIOLOGICAL

IV solution, IV, 500 mg/m2, Once every 3 weeks during Treatment Phase, 10 minute infusion.

Interventions

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Ipilimumab

Intravenous (IV) solution, IV, 10mg/kg, Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion

Intervention Type BIOLOGICAL

Pemetrexed

IV solution, IV, 500 mg/m2, Once every 3 weeks during Treatment Phase, 10 minute infusion.

Intervention Type BIOLOGICAL

Other Intervention Names

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Yervoy BMS-734016 Alimta

Eligibility Criteria

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Inclusion Criteria

* Non-Squamous, Non-Small Cell Lung Cancer
* Recurrent/Stage IV Non-small cell lung cancer (NSCLC)
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
* Not progressing after 4 cycles of a platinum-based first line chemotherapy

Exclusion Criteria

* Brain Metastases (unless stable)
* Autoimmune Diseases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Marin Specialty Care, Inc.

Greenbrae, California, United States

Site Status

Medical And Surgical Specialists, Llc

Galesburg, Illinois, United States

Site Status

Quincy Medical Group

Quincy, Illinois, United States

Site Status

Montgomery Cancer Center

Mount Sterling, Kentucky, United States

Site Status

Meritus Center For Clinical Research

Hagerstown, Maryland, United States

Site Status

Carolina Biooncology Institute

Huntersville, North Carolina, United States

Site Status

Blue Ridge Cancer Care

Christiansburg, Virginia, United States

Site Status

Local Institution

Bruges, , Belgium

Site Status

Local Institution

Sint-Niklaas, , Belgium

Site Status

Local Institution

Paris, , France

Site Status

Local Institution

Hamburg, , Germany

Site Status

Local Institution

Heidelberg, , Germany

Site Status

Local Institution

Benidorm-Alicante, , Spain

Site Status

Countries

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United States Belgium France Germany Spain

Related Links

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Other Identifiers

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2011-000732-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA184-124 ST

Identifier Type: -

Identifier Source: org_study_id

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