lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female with histologically confirmed predominant non-squamous, non-small cell lung cancer; 2. 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 validated technique 3. Not suitable for radiation, inoperable stage III or stage IV 4. 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 5. 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).
Exclusion criteria
Exclusion criteria: 1. History of cancer except for skin cancer or cancer dating from over five years ago and considered to be cured; 2. 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; 3. Pregnancy and breast-feeding; 4. Patient taking hormone replacement therapy for menopause that has not been stopped two weeks before the start of the trial treatment; 5. A change in bone marrow, kidney and liver functions inconsistent with treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS;Overall Survival, OS; | — |
Countries
China
Contacts
Department of Thoracic Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China