Clinical trial NCT00349219 (phase 3, status: completed)
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, cisplatin, gemcitabine, cisplatin, gemcitabine, erlotinib
SMILES: COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2
Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of cytologically or histologically confirmed non-small cell lung cancer

          -  Metastatic (stage IV) or locally advanced (stage IIIB, with metastasis to
             supraclavicular nodes or with pleural effusion).

          -  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 criteria

          -  Male or female > 18 years of age (Italy upper age limit 70 years)

          -  ECOG PS 0 or 1

          -  Life expectancy of > 3 months

          -  Neutrophils > 1,500 mm3, platelets > 100,000 mm3, and hemoglobin > 9 g/dL

          -  Bilirubin level either normal or < 1.5 x ULN

          -  AST (SGOT) and ALT (SGPT) < 2.5 x ULN (< 5 x ULN if liver metastasis are present)

          -  Serum creatinine < 1.5 x ULN

          -  Effective contraception for both, male and female patients if the risk of conception
             exists

          -  Signed written informed consent

        Exclusion Criteria:

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

          -  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. Prior neoadjuvant chemotherapy for operable disease or adjuvant
             chemotherapy is permitted if it did not contain gemcitabine and if at least 1 year
             elapsed from the end of chemotherapy and the date of relapse.

          -  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 past 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 are excluded if they have brain metastasis or spinal cord compression that
             has not yet been definitively treated with surgery and/or radiation; previously
             diagnosed and treated CNS metastases or spinal cord compression without evidence of
             stable disease (clinically stable imaging) for at least 2 months will also cause
             patients to be excluded. Patients with asymptomatic CNS metastases and not requiring
             steroids to control symptoms can be included, even if on anti-seizure medications.

          -  HIV positive patients

          -  Any inflammatory changes of the surface of the eye at baseline

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

          -  Nursing and/or pregnant females

          -  Known or suspected hypersensitivity to any of the study drugs.