NCT00758134

Trastuzumab Therapy in Non-Small Cell Lung Cancer Patients

Prospective Phase II Trial Evaluating Efficacy of Trastuzumab Therapy in HER2 FISH Positive and/or HER2 Mutation Positive, Pretreated, Non-Small Cell Lung Cancer Patients (MO20509)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Armando Santoro, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective study assessing efficacy of trastuzumab therapy in pretreated NSCLC patients. Patients with locally advanced or metastatic NSCLC, HER2 FISH positive and/or with HER2 gene mutation, pretreated with at least one previous chemotherapy line will be considered eligible for the trial. After evaluation of inclusion and exclusion criteria, and after signature of informed consensus form, all eligible patients will receive trastuzumab 6 mg/kg every 3 weeks (8 mg/kg loading dose) until disease progression, unacceptable toxicity or patient refusal.

Conditions

• NON-SMALL CELL LUNG CANCER

Interventions

Type	Name	Description
DRUG	Trastuzumab (Herceptin)	Trastuzumab 6 mg/Kg every 3 weeks i.v. (loading dose 8 mg/Kg i.v.)

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-06-01
• Completion: 2010-12-01
• First posted: 2008-09-23
• Last updated: 2013-05-29

Locations

1 site across 1 country: Italy