Taxotere-Mono Studie: 1st-Line Docetaxel versus Gemcitabin Monotherapie mit festgelegter platinhaltiger 2nd-Line bei PD bei Patienten mit metastasiertem nicht-kleinzelligem Bronchial-Karzinom; eine randomisierte, Phase II Studie English translation: clinical trial Taxotere Monotherapy: 1st-line Docetaxel versus Gemcitabine monotherapy with defined 2nd-line containing platinum when PD occurs, in patients with metastatic non small cell lung cancer; a randomized, phase II trial - 1st line Docetaxel vs. Gemcitabin (Monotherapie)

INTERVENTION: Trade Name: Taxotere 80 mg Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: DOCETAXEL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80‐ Trade Name: Taxotere 20 mg Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: DOCETAXEL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Trade Name: Gemzar Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: GEMCITABINE CAS Number: 95058814 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Product Name: Cisplatin Pharmaceutical Form: Solution for infusion INN or Proposed INN: CISPLATIN CAS Number: 15663271 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0,5‐1,0 Trade Name: Gemzar Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: GEMCITABINE CAS Number: 95058814 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000‐ CONDITION: Treatment of metastatic non small cell lung cancer (NSCLC) ; MedDRA version: 8.1 Level: LLT Classification code 10029514 Term: Non‐small cell lung cancer NOS PRIMARY OUTCOME: Main Objective: The primary objective is to compare the efficacy and tolerability between two platinum‐free therapeutic regimens in patients with metastatic non small cell lung cancer and to show that the Taxotere treatment arm is not inferior to the Gemzar treatment arm with regard to progression free survival. Primary end point(s): The primary analysis variable is progression free survival after protocol defined therapy (one complete course of Docetaxel or Gemcitabine). ; Progression free survival is defined as the interval from the date of randomisation to the first documented progression or death. Secondary Objective: Secondary objectives are the determination of / comparison between both treatment arms concerning: ; ; Toxicity, response rate, overall survival, quality of life. INCLUSION CRITERIA: ‐Histologically or cytologically proven inoperable non small cell lung cancer stage IV without prior treatment with chemotherapy (1st‐line), except adjuvant or neo‐adjuvant chemotherapy for treatment of NSCLC that was administered at least two years prior to randomisation in this study. ‐Patients with a measurable disease, i.e. at least one measurable lesion, which can be visualized by means of clinical radiologic procedures (x‐ray, CT) according to RECIST. ‐Age = 18 years. ‐Life expectancy = 12 weeks. ‐General condition according to ECOG Perfomance Status less than or equal to 2. ‐effective contraception in men and women if the possibility of conception is given (oral contraceptives with estrogen and gestagen (no minipill), vaginal ring pessary, contraceptive plaster, estrogen‐free ovulation inhibitor, hormonal intrauterine device with progesterone, 3‐months injectables with depot gestagen, hormone releasing implants (contraceptive r