MedTrace Logo

Paclitaxel-trastuzumab in EGFR-mutated NSCLC Patients

NCT02226757 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-08-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Amsterdam UMC, location VUmc

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-08-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02226757 on ClinicalTrials.gov