A Study of Mapatumumab in Combination With Paclitaxel and Carboplatin in Subjects With Non-small Cell Lung Cancer (NSCLC)

Human Genome Sciences

Status and phase: Completed; Phase 2

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Paclitaxel; Biological: Mapatumumab; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00583830

HGS1012-C1072

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy (disease response) and safety of mapatumumab in combination with carboplatin and paclitaxel as first line therapy in subjects with advanced non-small cell lung cancer (NSCLC).

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with histologically or cytologically confirmed stage IIIB or stage IV advanced primary non-small cell lung cancinoma
• Age 18 years or older

Exclusion criteria

• Received investigational (not yet approved by a regulatory authority) or non-investigational agent to treat Lung Cancer
• Received radiation therapy within 4 weeks before randomization
• Major surgery within 4 weeks before randomization
• Minor surgery within 2 weeks before randomizaiton
• Systemic steroids within 1 week before randomization
• Any grade 2 or greater neuropathy
• History of severe (Grade 4) hypersensitivity reaction to products containing Cremophor EL (cyclosporine, teniposide)
• History of any infection requiring hospitalization or antibiotics within 2 weeks before randomization
• Known brain or spinal cord metastases
• History of other cancers within 5 years before randomization
• Known HIV, hepatitis-B or hepatitis-C infection
• Pregnant or breast-feeding women
• Previously treated with Mapatumumab

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 3 patient groups

A

Active Comparator group

Description:

Paclitaxel and carboplatin

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

B

Experimental group

Description:

Paclitaxel, carboplatin and Mapatumumab 10 mg/kg

Treatment:

Biological: Mapatumumab

Drug: Paclitaxel

Drug: Carboplatin

Biological: Mapatumumab

C

Experimental group

Description:

Paclitaxel, carboplatin and Mapatumumab 30 mg/kg

Treatment:

Biological: Mapatumumab

Drug: Paclitaxel

Drug: Carboplatin

Biological: Mapatumumab