Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
National Cancer Institute, Naples
Age
70–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of cytologically or histologically confirmed non-small cell lung cancer.
Non squamous tumor type (including those with a non-specified tumor type).
Metastatic (stage IV, both M1A or M1B) or locally advanced (stage IIIB, with metastasis to supraclavicular nodes) according to TNM VII edition.
Both patients at first diagnosis or those with disease recurrence after former surgery are eligible.
At least one target or non-target lesion according to RECIST revised version 1.1.
Male or female \> or = 70 years of age.
ECOG PS 0 or 1.
Life expectancy \> 3 months.
Neutrophils \> or = 1500 mm3, platelets \> or = 100000 mm3, and haemoglobin \> or = 9 g/dL.
Bilirubin level either normal or \< 1.5 x ULN.
AST (SGOT) and ALT (SGPT) \< or = 2.5 x ULN (\< or = 5 x ULN if liver metastasis are present).
Serum creatinine \< 1.5 x ULN.
Signed written informed consent.
Known or suspected hypersensitivity to any of the study drugs
You may not be if
Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease. Prior surgery and/or localised irradiation is permitted. Prior adjuvant chemotherapy is permitted if it did not contain gemcitabine and pemetrexed and if at least 6 months elapsed from the end of adjuvant chemotherapy.
Any unstable systemic disease (including active infections, significant cardiovascular disease or myocardial infarction within the previous year, any significant hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study medications or render the patient at high risk from treatment complications.
Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal PSA).
