Clinical trial NCT00783471 (phase 2, status: terminated)
Conditions: advanced non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: erlotinib, docetaxel, docetaxel, erlotinib
SMILES: COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2, COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2
Reason stopped: 
    the low accrual rate of the study (30% of the expected accrual rate)/low efficacy in both
    treatment arms.
  
Eligibility criteria:

        Inclusion Criteria:

          1. Male and female patients aged 18 to 75 years inclusive, with histologically confirmed
             metastatic NSCLC will be enrolled.

          2. Patients must have not been previously treated with anticancer drugs for advanced
             disease.

          3. ECOG performance status of 0 - 1.

          4. Life expectancy of at least 12 weeks.

          5. Patients must be able to take oral medication.

          6. At least 4 weeks since any prior major surgery or extended-field radiotherapy.
             Patients who, in the opinion of the investigator, have fully recovered from limited
             surgery or have undergone limited-field radiotherapy within 2 weeks may also be
             considered eligible for the study

          7. Granulocyte count > 1,500/mm3 and platelet count > 100,000/mm3. Haemoglobin ³ 9.0g/dl.

          8. SGOT (AST) and SGPT (ALT) < 2,5 x ULN in the absence of liver metastases or up to 5 x
             ULN in case of liver metastases

          9. Alkaline phosphatase (ALP) < 2,5 x ULN. If alkaline phosphatase is > 2.5 x ULN, SGOT
             (AST) and SGPT (ALT) must be < 1.5 x ULN. If alkaline phosphatase is ³ 2.5 x ULN in
             the presence of liver metastases, SGOT and SGPT must be < 5 x ULN

         10. Serum creatinine <= 1.5 ULN or creatinine clearance > 60 ml/min.

         11. Normal serum calcium.

         12. For all females of childbearing potential a negative pregnancy test must be obtained
             within 48 hours before starting Tarceva/placebo treatment.

         13. Patients with reproductive potential must use effective contraception.

         14. Able to comply with study and follow-up procedures.

         15. Written (signed) Informed Consent to participate in the study.

         16. Written (signed) Informed Consent for use of tumour samples.

         17. Presence of measurable or evaluable disease (lesions that are present but do not
             fulfil the criteria for measurable disease).

         18. Formalin-fixed, paraffin-embedded tumour tissue samples representative of the tumour
             will be provided to sponsor within 3 weeks of the patient starting chemotherapy

        Exclusion Criteria:

          1. Prior exposure to agents directed at the HER axis (e.g. gefitinib, cetuximab,
             trastuzumab).

          2. Prior chemotherapy or therapy with systemic anti-neoplastic therapy (e.g., monoclonal
             antibody therapy) for advanced disease. Prior surgery and/or localised irradiation is
             permitted.

          3. Patients who have undergone complete tumour resection after responding to platinum
             based chemotherapy.

          4. Any unstable systemic disease (including active infections, significant cardiovascular
             disease, [including 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
             medication(s) or that might affect the interpretation of the results or render the
             patient at high risk from treatment complications.

          5. Any other malignancies within 5 years (except for adequately treated carcinoma in situ
             of the cervix or basal or squamous cell skin cancer).

          6. Patients are excluded if they have symptomatic brain metastasis or spinal cord
             compression that has not yet been definitively treated with surgery and/or radiation;
             patients with CNS metastases with evidence of stable disease (clinically stable
             imaging) and stable neurologic function are allowed to enter the study.

          7. Patients who are at risk (in the investigator's opinion) of transmitting human
             immunodeficiency virus (HIV) through blood or other body fluids are excluded.

          8. Any inflammatory changes of the surface of the eye.

          9. Patients who cannot take oral medication, who require intravenous alimentation, have
             had prior surgical procedures affecting absorption, or have active peptic ulcer
             disease.

         10. Nursing and/or pregnant women.

         11. Hypersensitivity to erlotinib (Tarceva) or to docetaxel or to any of the excipients.