Docetaxel/Pemetrexed as 1st Line Treatment in Patients With Non Small Cell Lung Cancer (NSCLC)

Inclusion Criteria:

* Histologically confirmed inoperable (stage IIIB-IV) NSCLC. A block of Formaline Fixed Parafine Embedded tissue representative for the primary diagnosis should be available for genomic analysis (phase II part)
* Written informed consent
* Prior chemotherapy with platinum compounds in association with or without taxanes (phase I part)
* Previously untreated with docetaxel and pemetrexed (phase II part)
* Bidimensionally, non-irradiated measurable disease (according to RECIST criteria) (phase II)
* Age ≥18 years
* World Health Organization (WHO) performance status (PS) 0-2
* Life expectancy of at least 12 weeks
* Serum bilirubin less than 1.5 times the upper normal limit (UNL)
* AST and ALT less than 2.5 times the UNL in the absence of demonstrable liver metastases, or less than 5 times the UNL in the presence of liver metastases.
* Serum creatinine less than 1.5 times the UNL
* Neutrophil count more than 1.5x 109 /L
* Platelet count more than 100x 109 /L

Exclusion Criteria:

* Other co-existing malignancies or malignancies diagnosed within the last 5 years (with the exception of basal cell carcinoma or cervical cancer in situ)
* Any evidence of severe uncontrolled concomitant disease (in the opinion of the investigator)
* Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
* Patients with unstable central nervous system metastases
* Malnutrition (loss of ≥ 20% of the original body weight)
* Performance status: 4
* Psychiatric illness or social situation that would preclude study compliance
* Pregnant or lactating women