E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
PATIENTS WITH ADVANCED NON-SMALL-CELL LUNG CANCER |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061873 |
E.1.2 | Term | Non-small cell lung cancer |
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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 |
To assess the antitumor activity and safety of vinorelbine given for six courses in combination with cisplatin versus docetaxel and cisplatin in combination.. |
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E.2.2 | Secondary objectives of the trial |
To determine the time to progression, the time to treatment failure and the overall survival in each treatment arm. To evaluate the quantitative and qualitative aspects of safety in each treatment arm. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Histologically or cytologically confirmed diagnosis of NSCLC; 2. Histologic subtypes may include large cell, squamous cell, or adenocarcinoma or a generic cytological diagnosis of NSCLC; 3. Patients must have a locoregionally advanced unresectable non metastatic NSCLC Stage IIIB only N3 supraclavicular or T4 for pleural effusion or Stage IV according to the revised International Staging System; 4. Patients must have at least one measurable lesion according to RECIST criteria. 5. Previous radical surgery more 30 days before study entry is allowed but a pathologic proof of progression of neoplastic disease must be documented; 6. Males or females aged between 18 and 70 years; 7. WHO Performance Status 0 or 1 Appendix I ; 8. Weight loss 5 within the last 3 months; 9. Laboratory requirements at entry - Blood cell counts Absolute neutrophils 2.0 . 109/L; Platelets 100 . 109/L; Hemoglobin 10 g/dl - Renal function Serum creatinine 1 upper normal limits UNL . In case of limit value of serum creatinine, the creatinine clearance should be 60 mL/min - Hepatic functions Serum bilirubin 1 x UNL; ASAT and ALAT 2.5 x UNL; Alkaline phosphatase 5 x UNL unless accompanied by extensive bone metastases 10. Obtained signed informed consent prior to start protocol specific requirements; 11. Patient compliance and geographic proximity that allow adequate follow-up. |
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E.4 | Principal exclusion criteria |
Prior systemic chemotherapy or immunotherapy. Prior neoadjuvant or adjuvant chemotherapy is allowed if ended at least 12 months before enrollment; 2. Prior radiotherapy for NSCLC to measurable lesions. Prior radiotherapy to 25 of the bone marrow is allowed in non target lesions. At least 4 weeks must be elapsed since the completion of the radiation therapy and the patient must have all side effects recovered. 3. Cyto-histological diagnosis of small cell lung cancer, carcinoid, or mixed small-cell / non-small cell lung cancer; 4. Patients with evaluable, not measurable disease only non target lesions ; 5. Patients with symptomatic brain metastases or with leptomeningeal disease; 6. History of prior malignancies, except for cured non melanoma skin cancer, curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years; 7. History of hypersensitivity reaction to polysorbate 80; 8. Pregnant or lactating women women of childbearing potential must use adequate contraception ; 9. Current peripheral neuropathy NCI grade 2; 10. Significant neurological or psychiatric disorders such as dementia that would prohibit them to understanding or rendering informed consent or from fully complying with treatment and follow-up; 11. Participation in clinical trials with other experimental agents within 30 days of study entry; 12. Other serious concomitant illness of medical conditions a Congestive heart failure or angina pectoris except if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmia; b History of significant neurologic or psychiatric disorders including demential or seizures; c Active infection requiring iv antibiotics; d Active ulcer, unstable diabetes mellitus or other contra-indication to corticotherapy; e Any other condition which in the judgement of the investigator would place the subject at undue risk or interfere with the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To assess the antitumor activity and safety of vinorelbine given for six courses in combination with cisplatin versus docetaxel and cisplatin in combination.. |
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | No |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.5 | 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 | Information not present in EudraCT |
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 | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |