Hoog-gedoseerde, pulsatiele erlotinib na progressie op standaard dosering erlotinib bij EGFR-gemuteerde NSCLC patienten.
Completed
- Conditions
- PulsatileErlotinibNSCLCEGFR mutation
- Registration Number
- NL-OMON20474
- Lead Sponsor
- VU Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
1. Histologically confirmed stage IV non-squamous NSCLC patients;
2. 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);
Exclusion Criteria
1. No uncontrolled infectious disease;
2. No other active malignancy;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the objective response rate (ORR) at 8 weeks according to the response evaluation criteria in solid tumors (RECIST v1.1).
- Secondary Outcome Measures
Name Time Method 1. To assess progression-free survival (PFS) at six months;<br /><br>2. To assess toxicity of high-dose erlotinib according to CTC AE 4.0.<br>