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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: Lung Cancer - Non Small Cell

Treatments: Biological: Pemetrexed; Biological: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01471197

2011-000732-29 (EudraCT Number)

CA184-124 ST

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email [e-mail]. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Arm 1: Ipilimumab

Experimental group

Treatment:

Biological: Ipilimumab

Arm 2: Pemetrexed

Active Comparator group

Treatment:

Biological: Pemetrexed