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

Study Overview
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Brief Summary
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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).

Official Title
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A Phase 2, Randomized, Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Mapatumumab in Combination With Carboplatin and Paclitaxel as First Line Therapy in Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Biological: Mapatumumab
* Biological: Mapatumumab
* Drug: Paclitaxel
* Drug: Carboplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Paclitaxel and carboplatin | Drug: Paclitaxel<br>* 200 mg/m^2 IV (in the vein), on day 1 of each 21 day cycle<br>* Other names: Paxene;Drug: Carboplatin<br>* AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle<br>* Other names: Paraplatin;|
| Experimental: B<br>Paclitaxel, carboplatin and Mapatumumab 10 mg/kg | Biological: Mapatumumab<br>* 10 mg/kg IV (in the vein), on day 1 of each 21 day cycle<br>Drug: Paclitaxel<br>* 200 mg/m^2 IV (in the vein), on day 1 of each 21 day cycle<br>* Other names: Paxene;Drug: Carboplatin<br>* AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle<br>* Other names: Paraplatin;|
| Experimental: C<br>Paclitaxel, carboplatin and Mapatumumab 30 mg/kg | Biological: Mapatumumab<br>* 30 mg/kg IV (in the vein), on day 1 of each 21 day cycle<br>Drug: Paclitaxel<br>* 200 mg/m^2 IV (in the vein), on day 1 of each 21 day cycle<br>* Other names: Paxene;Drug: Carboplatin<br>* AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle<br>* Other names: Paraplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response and Progression free survival |  | 6 cycles, or until disease progression or unacceptable toxicity develops | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control; Overall survival; Response duration and time to response in responders; Frequency and severity of treatment-emergent adverse events; Laboratory parameters; and Serum mapatumumab concentrations for use in a PK analysis. |  | 6 cycles, or until disease progression or unacceptable toxicity develops | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer