Phase II Randomised Clinical Trial Evaluating an EGFR Tyrosine Kinase Inhibitor (EGFR-TKI) Versus an EGFR-TKI Combined With an Anti-oestrogen Treatment (Fulvestrant) in Women With Advanced Stage Non-squamous Lung Cancer
- Histologically confirmed predominant non-squamous, non-small cell lung cancer
- The presence of analysable tissue for the research of EGFR activating mutation.
Analysis must be performed in INCa-labelled laboratories or platforms according to a
- Not suitable for radiation, inoperable stage III or stage IV
- Patients with an EGFR mutation must never have taken chemotherapy or must be in
progression after only one previous line of chemotherapy (including maintenance).
Patients without an EGFR mutation must have received one or two lines of chemotherapy
beforehand. Maintenance chemotherapy is not considered to be a treatment line.
Adjuvant chemotherapy is not considered to be a first line of treatment if it dates
back to over a year
- Menopausal: older than 60 years of age or history of ovariectomy or younger than 60
years old with amenorrhoea for more than 12 months or an FSH rate that corresponds to
a post-menopausal rate (according to the laboratory)
- History of cancer except for skin cancer or cancer dating from over five years ago
and considered to be cured
- Known or suspected Cerebral metastases or spinal cord compression unless they are
asymptomatic without treatment or stable after being treated by surgery and/or
radiation therapy. Corticosteroid treatments for symptoms must have discontinued for
more than four weeks
- Pregnancy and breast-feeding
- Patient taking hormone replacement therapy for menopause that has not been stopped
two weeks before the start of the trial treatment
- A change in bone marrow, kidney and liver functions inconsistent with treatment