Gefitinib and fulvestrant in patients with advanced, EGFR mutated NSCLC pretreated with EGFR TKI's.
Completed
- Conditions
- Patients with pathologically documented NSCLC with an EGFR mutation, who failed previous treatment with reversible EGFR TKI’s (gefitinib or erlotinib).
- Registration Number
- NL-OMON28300
- Lead Sponsor
- VU University Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
Inclusion Criteria
1. Histologically or cytologically confirmed NSCLC locally advanced and metastatic disease stage IIIB and IV, that have an activating EGFR mutation, progressive on treatment with gefitinib or erlotinib. 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;
2. At least one unidimensionally measurable lesion meeting RECIST 1.1 criteria;
Exclusion Criteria
1. Pregnant or lactating women;
2. Patients who are poor medical risks because of non-malignant disease as well as those with active uncontrolled infection;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the rate of no progression (NPR) at 8 weeks following treatment with the combination of gefitinib and fulvestrant in EGFR mutated patients who failed previous treatment with reversible EGFR TKI’s (gefitinib or erlotinib).
- Secondary Outcome Measures
Name Time Method 1. Quantitative and qualitative toxicities of this regimen;<br /><br>2. Duration of response for responding patients;<br /><br>3. Time to progression or death;<br /><br>4. Progression free survival;<br /><br>5. Overall survival.