NSCLC with EGFR mutation
Conditions
Interventions
Trade Name: Paclitaxel
Product Name: Paclitaxel
Pharmaceutical Form: Infusion
INN or Proposed INN: PACLITAXEL
CAS Number: 33069-62-4
Concentration unit: mg/m2 milligram(s)/square meter
Concentration t
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
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%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess partial response rate according to RECIST 1.1;Secondary Objective: Progression-free survival, disease controle rate and toxicity;Primary end point(s): Objective response rate;Timepoint(s) of evaluation of this end point: After 6 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): disease controle rate, progression-free survival, toxicity;Timepoint(s) of evaluation of this end point: End of study | — |
Countries
Netherlands
Outcome results
None listed