MILES-4: Study Comparing Gemcitabine and Pemetrexed, With or Without Cisplatin, in Patients With Nonsquamous Lung Cancer

Inclusion Criteria

• •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