Paclitaxel-trastuzumab in EGFR-mutated NSCLC patients after progression on TKI-treatment; a pilot study

Phase 2

Completed

Conditions: Lung Cancer
non-small cell lung cancer
10038666

Registration Number: NL-OMON44719

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 21

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 IHC*1 according to routine tests for HER2-evaluation) 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.
* Women of child-bearing potential: Nnot pregnant (negative serum test) or breast feeding and willing to take adequate contraceptive measures during the study and for seven months after completion of the treatment with trastuzumab.
* Ability to give written informed consent before patient registration.

Exclusion Criteria

* No uUncontrolled infectious disease.
* No oOther active malignancy.
* No mMajor surgery (excluding diagnostic procedures like e.g. mediastinoscopy or VATS biopsy) in the previous 4 weeks.
* No tTreatment with investigational drugs within the previous 4 weeks.
* No kKnown hypersensitivity to trastuzumab-paclitaxel
* No sSymptomatic brain metastases.
* History of coronary artery disease, NYHA class III or IVor documented congestive heart failure, angina pectoris requiring medication, NYHA class III or IV, electrocardiogram (ECG) evidence of trans-mural myocardial infarction, poorly controlled hypertension (systolic blood pressure [BP] > 180 mmHg or diastolic BP > 100 mmHg), clinically significant valvular heart disease, or high risk for uncontrollable arrhythmias and Left Ventricular Ejection Fraction (LVEF) of <5545%.
* Haematology: Leucocytes <3.0 109 /L, Thrombocytes < 100.0 x 109 /L
* Biochemistry: bilirubin > 30 umol/L, AF > 300, GGT > 130, ASAT > 80, ALAT > 100