Paclitaxel-trastuzumab in EGFR-mutated NSCLC Patients

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02226757
• Other study ID #: HER2-targeting in EGFR-mutated
• Status: Not yet recruiting
• Phase: Phase 2
• First received: June 2, 2014
• Last updated: August 25, 2014
• Start date: August 2014

Study information

• Verified date: August 2014
• Source: VU University Medical Center
• Contact: Justine Kuiper, MD
• Phone: 0031204442214
• Email: jl.kuiper[@]vumc.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed stage IV non-squamous NSCLC patients.

• Patients must have been detected with an activating EGFR mutation at baseline and must have yet progressed on erlotinib, gefitinib or afatinib monotherapy in daily dose of 150 mg, 250 mg or 40 mg respectively. (Patients with unknown mutation status that have exhibited a response to these agents or stable disease for at least 6 months while on treatment with gefitinib or erlotinib are also eligible).

• Rebiopsy after having acquired resistance to TKI-treatment must have been performed and HER2-overexpression (positive immunohistochemistry staining) must have been detected.

• There must be at least one measurable disease site, according to RECIST 1.1 criteria.

• WHO performance status 0-2.

• Willing and able to comply with the study prescriptions.

• 18 years or older.

• Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study.

• Ability to give written informed consent before patient registration.

Exclusion Criteria:

• No uncontrolled infectious disease.

• No other active malignancy.

• No major surgery (excluding diagnostic procedures like e.g. mediastinoscopy or VATS biopsy) in the previous 4 weeks.

• No treatment with investigational drugs.

• No known hypersensitivity to trastuzumab-paclitaxel

• No symptomatic brain metastases.

• History of coronary artery disease, NYHA class III or IV and Left Ventricular Ejection Fraction (LVEF) of <45%.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• EGFR-mutation
• HER2-expression
• NSCLC

Intervention

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

Locations

Country	Name	City	State
Netherlands	VU University medical Center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate		6 weeks	No
Secondary	Disease control rate		6 weeks	No
Secondary	progression-free survival		2 years	No
Secondary	Toxicity		2 years	Yes