Patients with pathologically documented NSCLC with an EGFR mutation, who failed previous treatment with reversible EGFR TKI’s (gefitinib or erlotinib).
Conditions
Interventions
Trade Name: Fulvestrant (faslodex)
Product Name: Fulvestrant
Product Code: Fulvestrant
Pharmaceutical Form: Injection
INN or Proposed INN: FULVESTRANT
CAS Number: 129453-61-8
Current Sponsor code: ful
Sponsors
VU Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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 criteria 3. ECOG PS 0-2 4. Age > 18 years 5. Adequate organ function, including: a. Adequate bone marrow reserve: ANC > 1.5 x 109/L, platelets > 100 x 109/L. b. Hepatic: bilirubin 45 ml/min based on the Cockroft and Gault formula. 6. Signed informed consent 7. Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with childbearing potential must have a negative serum pregnancy test within 14 days prior to study enrollment. 8. Estimated life expectancy >12 weeks. 9. Patient compliance and geographical proximity that allow adequate follow up. 10. NSCLC with an activating sensitising EGFR TK mutation as determined by using a well-validated and robust methodology. 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 48 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion 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. 3. Documented brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least two weeks before enrollment. 4. Concomitant treatment with any other experimental drug under investigation. 5. Known severe hypersensitivity to gefitinib or any of the excipients of the product. 6. Presence of EGFR TK mutation reported to confer resistance to EGFR TKI: i.e., exon 20 point mutation (T790M or S768I EGFR) or exon 20 insertion as determined by using a well-validated and robust methodology. 7. Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease. 8. Concomitant use of known CYP 3A4 inducers such as phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort. 9. Previous enrolment or treatment in the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: to assess the rate of no progression (NPR) at 8 weeks following treatment of gefitinib and fulvestrant in EGFR mutated patients who failed previous treatment with reversible TKI’s. ;Secondary Objective: Secondary objective: to characterize the quantitative and qualitative toxicities of this regimen, duration of response for responding patients and overall survival.;Primary end point(s): rate of no progression (NPR) at 8 weeks ;Timepoint(s) of evaluation of this end point: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Quantitative and qualitative toxicities of this regimen - Duration of response for responding patients - Time to progression or death - Progression free survival - Overall survival ;Timepoint(s) of evaluation of this end point: 8 weeks, every 4 weeks and at disease progression | — |
Countries
Netherlands
Contacts
Public ContactEF Smit
VUMC
Outcome results
None listed