A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer Not Progressing on First Line Cisplatin-gemcitabine Chemotherapy Maintenance Chemotherapy With Gemcitabine or Sequential Treatment With Erlotinib
- Histologically documented NSCLC (tumor tissue samples will be provided to look for
assessment of EGFR status with CISH, immunochemistry and mutations) : adenocarcinoma,
squamous cell carcinoma, large cell carcinoma. A cytological documentation of NSCLC
- Stage IV disease or metastatic relapse in not previously irradiated areas of a NSCLC
previously treated with surgery or radiation therapy (with a histologically
documented proof of relapse) or stage III B with documented pleural involvement.
- Measurable disease according to the RECIST criteria.
- Prior radiotherapy authorized except for irradiation concerning measurable disease.
- Age >18 and < 70 years.
- PS < 2.
- Normal hepatic function : serum bilirubin < 1.5 ULN, SGOT (ASAT) and SGPT (ALAT) <
2,5 ULN ; in presence of liver metastases, SGOT and SGPT must be < 5 x ULN.
- Creatinine clearance > 60 mL/min.
- Granulocyte count > 1,5 giga/L, platelet count > 100 giga/L.
- Life expectancy > 12 weeks.
- Written (signed) informed consent for use of tumors samples.
- Written (signed) informed consent to participate in the sudy.
- Small cell lung cancer, bronchiolo-alveolar carcinoma, neuro-endocrine carcinoma.
- PS > 1.
- Prior chemotherapy other than cisplatin-gemcitabine.
- Prior therapy with EGFR inhibitor (e.g. monoclonal antibody).
- No concomitant therapy with phenytoin, carbamazepine, rifampicine or phenobarbital.
- Concomitant radiotherapy except for localized bone irradiation.
- Symptomatic brain metastases.
- Superior vena cava syndrome.
- Any unstable systemic disease : significant cardiovascular disease including
myocardial infarction within the previous year, active infection, significant hepatic
or renal disease.
- Pre-existing interstitial lung disease.
- Any inflammatory changes of the surface of the eyes.
- Psychiatric disease with inability to understand the study or to comply with
- Grade > or = 2 peripheral neuropathy.
- Any other malignancies within 5 years (except for treated carcinoma in situ of the
cervix or basal cell skin cancer).
- Pregnant or lactating women ; patients with reproductive potential must use effective
- Inability to comply with follow-up procedures.