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Paclitaxel-trastuzumab in EGFR-mutated NSCLC Patients

Primary Purpose

NSCLC, HER2-expression, EGFR-mutation

Status

Unknown status

Phase

Phase 2

Locations

Netherlands

Study Type

Interventional

Intervention

Paclitaxel-trastzumab

About this trial

This is an interventional treatment trial for NSCLC focused on measuring NSCLC, HER2-expression, EGFR-mutation, Trastuzumab, Paclitaxel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%.

Sites / Locations

VU University medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paclitaxel-trastuzumab

Arm Description

Paclitaxel-trastuzumab weekly

Outcomes

Primary Outcome Measures

Objective response rate

Secondary Outcome Measures

Disease control rate

progression-free survival

Toxicity

Full Information

NCT ID

NCT02226757

First Posted

June 2, 2014

Last Updated

August 25, 2014

Sponsor

Amsterdam UMC, location VUmc

1. Study Identification

Unique Protocol Identification Number

NCT02226757

Brief Title

Paclitaxel-trastuzumab in EGFR-mutated NSCLC Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Unknown status

Study Start Date

August 2014 (undefined)

Primary Completion Date

August 2016 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Amsterdam UMC, location VUmc

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NSCLC, HER2-expression, EGFR-mutation

Keywords

NSCLC, HER2-expression, EGFR-mutation, Trastuzumab, Paclitaxel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Paclitaxel-trastuzumab

Arm Type

Experimental

Arm Description

Paclitaxel-trastuzumab weekly

Intervention Type

Drug

Intervention Name(s)

Paclitaxel-trastzumab

Intervention Description

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

Primary Outcome Measure Information:

Title

Objective response rate

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Disease control rate

Time Frame

6 weeks

Title

progression-free survival

Time Frame

2 years

Title

Toxicity

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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%.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Justine Kuiper, MD

Phone

0031204442214

jl.kuiper@vumc.nl

Facility Information:

Facility Name

VU University medical Center

City

Amsterdam

ZIP/Postal Code

1007MB

Country

Netherlands

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Justine Kuiper, MD

Phone

+31204442214

jl.kuiper@vumc.nl

12. IPD Sharing Statement

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Paclitaxel-trastuzumab in EGFR-mutated NSCLC Patients

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