Paclitaxel-trastuzumab in Lung cancer-patients with an EGFR mutatio

Phase 1

• Conditions: SCLC with EGFR mutation; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-002238-29-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-08
• Last Update Posted: 5 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

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

• 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%.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): disease controle rate, progression-free survival, toxicity;Timepoint(s) of evaluation of this end point: End of study