Study of an Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer

Patients with stage IV NSCLC and measurable disease are included in a randomized phase II trial comparing for patients with stable disease after 2 cycles of a platin (P)-gemcitabine doublet (P d1: 75 mg/m2, gemcitabine 1 250 mg/m2 d1, d8 every three weeks) two subsequent cycles of this doublet (arm A) to a switch to another doublet (arm B) : paclitaxel 100 mg/m2 d1, d8, d15, gemcitabine 1 250 mg/m2 d1, d8, every four weeks.Platin, gemcitabine and paclitaxel are administered according nadir and pre-cycle haematologic evaluations (with dose decrease if needed). Response criteria are assessed with RECIST classification by the investigator panel.

Inclusion criteria

• Histologically or cytologically proved stage IV or pleural stage III NSCLC (neoplastic pleurisy confirmed).
• Metastatic relapses allowed in not irradiated area.
• Age between 18 and 70 years
• Chemonaïve patients
• At least one measurable target lesion according to recist criteria in non previously irradiated area.
• Performance status < 2
• Normal hepatic and renal function, absolute neutrophil count >1,5 giga/l, platelets >100 giga/l.
• Written informed consent.
• Life expectancy > 12 weeks.

Exclusion criteria

• SCLC, bronchial-alveolar and neuro-endocrine carcinoma.
• Previous chemotherapeutic treatment.
• Symptomatic brain metastases.
• Superior vena cava syndrome.
• Other concomitant diseases: heart failure, angina pectoris, arrhythmia , recent myocardial infarction.
• Peripheral neuropathy grade ≥2.
• Past or concomitance of another cancer except baso-cellular carcinoma of the skin or in situ cervical carcinoma.
• Hypersensitivity to paclitaxel or polysorbate 80.
• Pregnancy or breast feeding.
• Any concomitant radiotherapy, except palliative bone irradiation.
• Follow-up of the patient impossible.
• Prisoners.