Multicentre Randomised Phase II Trial of Erlotinib Versus Carboplatin/Vinorelbine in Elderly Patients (=/> 70 Years) With Advanced Non-Small Cell Lung Cancer
Inclusion Criteria:
- Histologically or cytological proven NSCLC, stage lll b (with pleural effusion) or
stage lV.
- Tumour is locally advanced and not suitable for surgery and radiotherapy is not
indicated.
- Neither cytostatic nor immunological pre-treatment
- Age >70 years
- At least one measurable lesion (RECIST criteria) that was not previously irradiated
- ECOG Performance Status 0-1
- Life expectancy > 3 month
- Adequate bone marrow function: ANC > 1.5 x 109/L, Platelets > 100 x 109/L
- Adequate liver function: Total Bilirubin < 1.5 x ULN, GOT/GPT< 3 x ULN (existent
liver metastases < 5 x ULN)
- Adequate renal function:creatinine clearance > 45 ml/min (calculated according to
Cockroft-Gault)
- Fertile men must agree to use an effective method of birth control while
participating in this study
- Signed written informed consent
Exclusion Criteria:
- Uncontrolled metastasis in the CNS
- Acute, heavy uncontrolled infection
- Any other serious concomitant disease or medical condition, which could interfere
with participating in this study
- Severe hypersensitivity to Erlotinib or any other component
- Hypersensitivity to Carboplatin and/or other platinum compounds
- Hypersensitivity to Vinorelbin or other Vinca-alkaloids
- Patients with a history of other active malignancy in the past 5 years (with the
exception of carcinoma in situ of the cervix, non melanomatous skin cancers or local
prostate carcinoma that was surgically treated successfully) are excluded.
- Participation in another clinical trial with any investigational drug at the same
time or within 30 days prior to registration
- Psychological, familial, social or geographical situations limiting the compliance
with the study requirements