A Factorial Study Comparing Pemetrexed With Gemcitabine and Testing the Efficacy of the Addition of Cisplatin in Elderly Patients With Non Squamous Advanced, Metastatic or Recurrent NSCLC.
- 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
- 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
- Serum creatinine < 1.5 x ULN.
- Signed written informed consent.
- 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).
- Patients with symptomatic brain metastasis or spinal cord compression that has not
yet been treated with surgery and/or radiation; patients with CNS metastases or
spinal cord compression previously treated with surgery and/or radiation are eligible
if they are asymptomatic and do not require steroids (anti-seizure medications are
- Known or suspected hypersensitivity to any of the study drugs