E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients suffering from non-small cell lung cancer in an advanced stage and bad general condition
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Number of completed cycles of chemotherapy (without progression of the underlying disease or inacceptable toxicity) |
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E.2.2 | Secondary objectives of the trial |
Response rate according to RECIST criteria 1-year survival rate Median overall survival Progression-free survival Quality of life Treatment toxicity
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-histological or cytological proof of a non-small cell lung cancer (NSCLC), recently diagnosed or relapse after curative radiotherapy of operation -stage IIIb-"wet" (existence of malignant pleural or pericardial effusion) or IV (existence of distant metastases) according to UICC -ECOG performance status of 2 -detectable tumourous lesions, i.e. at least one lesion of >=1cm which is detectable by spiral-CT or MRT -no cytostatic treatment of the lung cancer including oral tyrosine kinase inhibitors ans antibodies -age >= 18 years -no other relevant pulmonal disease (FEV1 >=50% pp) -life expectancy of at least 12 weeks -adequate hematologic, renal, hepatic function according to the following definitions: •absolute count of neutrophiles >= 1,5*10^9 /l •platelets >=100*10^9/l •total bilirubine <=1,0*ULN •aspartate amino transferase and alanine amino transferase, each <=1,5*ULN •AP <=2,5*ULN •GFR (calculated) >=60 ml/min - signed (written) informed consent - women of child-bearing age: negative pregnancy test - women of child-bearing age: willingness to use highly effective contraceptive methods (Pearl Index <1, e.g.: birth control pill, loop, hormone implant, transdermal hormone patch, a combination of two barrier methods [condome and vaginal diaphragm] sterilisation or sexual abstinence) for the study duration and for 6 months following the trial
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E.4 | Principal exclusion criteria |
-Chemotherapeutic pretreatment (including oral inhibitors of tyrosinkinase and antibodies) -percutaneous radiation therapy on the primary tumor or on the mediastinum during the preceding 12 months (elevated risk of pulmonary toxicity) -in case of existence of brain metastases: whole brain radiation must be completed for at least three days and neurologic symptoms must be completely under control with 12 mg of Dexamethason per day -Intolerance against Gemcitabin or Docetaxel -other malignomas apart from NSCLC which emerged during the preceding 5 years or had to be treated during the preceding 5 years (barring basalioma of the skin or carcinoma in situ of the uterine cervix -preexisting motor or sensory neurotoxicity >= grade 2 -severe concomitant disease or medical disturbance which impair the patient´s ability to receive the correct therapy according to the protocol. For example: active infections including HIV/AIDS, manifest cardiac insufficiency, higher grade cardiac arrhythmia (worse than atrioventricular block grade I), myocardial infarction during the last 6 months, unstable angina pectoris) -application of any other drug during the preceding 30 days that is not approved or that is tested in a clinical trial -pregnant women, breast-feeding women, patients that might get pregnant during the course of the trial. In all women of child-bearing age a negative pregnancy-test before inclusion and the use of a highly effective contraceptive method is obligatory. -any other condition or therapy which may mean harm to the patient according to the opinion of the investigator or may impair the accomplishment of the trial
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of completed cycles of chemotherapy (without progression of the underlying disease or inacceptable toxicity) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |