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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00583830

Acronym

NSCLC

Enrollment

111

Registered

2007-12-31

Start date

2007-01-31

Completion date

2011-02-28

Last updated

2013-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Keywords

Lung Cancer

Brief summary

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).

Interventions

BIOLOGICALMapatumumab

30 mg/kg IV (in the vein), on day 1 of each 21 day cycle

DRUGPaclitaxel

200 mg/m\^2 IV (in the vein), on day 1 of each 21 day cycle

DRUGCarboplatin

AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Objective response and Progression free survival	6 cycles, or until disease progression or unacceptable toxicity develops

Secondary

Measure	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

Countries

Germany, Hungary, Romania, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026