NCT02226757

Paclitaxel-trastuzumab in EGFR-mutated NSCLC Patients

Paclitaxel-trastuzumab in EGFR-mutated NSCLC Patients After Progression on TKI-treatment; a Pilot-study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a pilot study in EGFR-mutated NSCLC patients who have progressed on standard-dose TKIs. Tumor biopsies will be evaluated for HER2-expression. In case of HER2 expression, patients can participate in the trial after obtaining informed consent. Patients will be treated with weekly paclitaxel-trastuzumab.

Conditions

• NSCLC
• HER2-expression
• EGFR-mutation

Interventions

Type	Name	Description
DRUG	Paclitaxel-trastzumab	Trastuzumab * Dose: * First dose: 4 mg/kg IV * Subsequent doses: 2 mg/kg every week IV. * The patient must be monitored for at least 6 hours after the start of the first infusion and for at least 2 hours after the start of subsequent infusions. Paclitaxel \- Dose: 60 mg/m2 IV in 30 minutes, every week, after trastuzumab

Timeline

• Start date: 2014-08-01
• Primary completion: 2016-08-01
• First posted: 2014-08-27
• Last updated: 2014-08-27

Locations

1 site across 1 country: Netherlands