Paclitaxel-trastuzumab in EGFR-mutated NSCLC Patients

NCT02226757 | Unknown Phase 2

• 1 other identifier: HER2-targeting in EGFR-mutated
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC; HER2-expression; EGFR-mutation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  6 weeks

Secondary Outcomes (3)

• Disease control rate

  6 weeks

• progression-free survival

  2 years

• Toxicity

  2 years

Study Arms (1)

Paclitaxel-trastuzumab

EXPERIMENTAL

Paclitaxel-trastuzumab weekly

Drug: Paclitaxel-trastzumab

Interventions

Paclitaxel-trastzumab DRUG

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

Paclitaxel-trastuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

VU University medical Center

Amsterdam, 1007MB, Netherlands

Location

Central Study Contacts

Justine Kuiper, MD

CONTACT

0031204442214; jl.kuiper@vumc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: August 27, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2016
• Last Updated: August 27, 2014

Record last verified: 2014-08

Locations

NL (1)