
    accrual to slow, target not achievable
  
['carcinoma, non-small cell lung']
['docetaxel', 'erlotinib']

        Inclusion Criteria:

          1. Histologically or cytologically confirmed EGFR wild type, ALK negative, non-squamous
             cell carcinoma, locally advanced and metastatic disease stage IIIB and IV. Evidence of
             disease progression after one cytotoxic treatment platinum containing regimen.
             Immunotherapy pretreatment is allowed

          2. Complete recovery from prior chemotherapy side effects to < Grade 2.

          3. At least one unidimensionally measurable lesion meeting RECIST criteria.

          4. ECOG PS 0-1.

          5. Age ≥ 18 years.

          6. Adequate organ function, including:

               -  Adequate bone marrow reserve: ANC > 1.5 x 109/L, platelets ≥ 100 x 109/L.

               -  Hepatic: bilirubin ≤1.5 x ULN (upper limit normal), AP, ALT, AST ≤ 1.5 x ULN. AP,
                  ALT, and AST ≤5 x ULN is acceptable if the liver has tumor involvement.

               -  Renal: calculated creatinine clearance ≥ 40 ml/min based on the Cockcroft-Gault
                  formula.

          7. Male and female patients with reproductive potential must use an approved
             contraceptive method, if appropriate. Female patients with childbearing potential must
             have a negative serum pregnancy test within 7 days prior to study enrollment.

          8. Signed informed consent.

          9. Patient compliance and geographical proximity that allow adequate follow up.

         10. Patients who have undergone cranial irradiation for brain metastases more than 4 weeks
             before inclusion in our protocol, provided that they are clinically fit to undergo
             second line treatment

        Exclusion Criteria:

          1. Pregnant or lactating women.

          2. Patients with medical risks because of non-malignant disease as well as those with
             active uncontrolled infection.

          3. Documented brain metastases unless the patient has completed local therapy for central
             nervous system metastases at least 4 weeks before enrollment and has been off
             corticosteroids for at least two weeks before enrollment. Prophylactic irradiation at
             least 4 weeks prior to enrollment is accepted.

          4. Maintenance treatment with erlotinib or other TKI (Tyrosine Kinase Inhibitor), or
             docetaxel. Maintenance treatment with pemetrexed is allowed. Previous treatment with
             an EGFR-TKI or docetaxel within 6 months prior to enrollment.

          5. Inability or unwillingness to take dexamethasone.

          6. Concomitant treatment with any other experimental drug under investigation.

          7. Patients experiencing disease progression within 2 months after the start of platinum
             based chemotherapy
      