High-dose, pulsatile erlotinib after progression on standard dose erlotinib in EGFR-mutated NSCLC patients
- Conditions
- Lung cancer10038666
- Registration Number
- NL-OMON36916
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
* Histologically confirmed stage IV non-squamous NSCLC patients.
* Patients with an activating EGFR mutation who progressed on erlotinib or gefitinib monotherapy in daily dose of 150 mg or 250 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).
* Tumor biopsy available for EGFR mutation analysis at progression
* 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 and having given written informed consent before patient registration.
Uncontrolled infectious disease.
Other active malignancy.
Major surgery (excluding diagnostic procedures like e.g. mediastinoscopy or VATS biopsy) in the previous 4 weeks.
Treatment with investigational drugs.
Known prior hypersensitivity to erlotinib.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the disease control rate (DCR) at 8 weeks according to the response<br /><br>evaluation criteria in solid tumors (RECIST v1.1)</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To assess progression-free survival (PFS)<br /><br>- To assess toxicity of high-dose erlotinib according to CTC AE 4.0.</p><br>