To investigate trastuzmab-paclitaxel in EGFR-mutated NSCLC patients who have overexpression of HER2 and who have progressed on standard TKI-treatment
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Objective response rate
Secondary outcome
disease controle rate, progression-free survival, overall survival, toxicity
Background summary
There are several indications that EGFR-mutated NSCLC patients who have HER2
overexpression may benefit from HER2-targeted treatment.
Study objective
To investigate trastuzmab-paclitaxel in EGFR-mutated NSCLC patients who have
overexpression of HER2 and who have progressed on standard TKI-treatment
Study design
Phase 2, pilot study. Open-label, single-phase.
Intervention
Weekly intravenously paclitaxel-trastuzmab
Study burden and risks
Although there are risks, participation is entirely justified. First, there is
no standard available 2nd line therapy. Second, patients will probably die soon
if no other treatment is started.
Boelelaan 1117
Amsterdam 1081HV
NL
Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | clinicaltrials.gov NCT02226757 |
| EudraCT | EUCTR201400223829-NL |
| CCMO | NL49479.029.14 |