E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-small cell lung cancer |
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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 |
To compare the efficacy in terms of survival time of gemcitabine plus cisplatin at 80mg/m2 versus gemcitabine plus cisplatin at 50mg/m2 versus gemcitabine plus carboplatin AUC 6 (Wright), in patients with advanced NSCLC |
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E.2.2 | Secondary objectives of the trial |
To compare the efficacy of gemcitabine plus cisplatin at 80mg/m2 versus gemcitabine plus cisplatin at 50mg/m2 versus gemcitabine plus carboplatin in terms of: 1) Symptom control and quality of life 2) Response to treatment 3) Dose intensity of chemotherapy 4) Ratio of cycles given as in-patient versus out-patient 5) Intensity, number and duration of toxic episodes 6) Costs and cost-effectiveness
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Proteomics. As per protocol version 4.4, 6th February 2007 |
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E.3 | Principal inclusion criteria |
· Histologically or cytologically confirmed NSCLC (excluding mixed SCLC/NSCLC) · Radiologically verified stage IIIB (unsuitable for radical radiotherapy) or stage IV disease (see Appendix 4) · Presence of 1 or more clinically or radiological measurable lesions by RECIST criteria (see Appendix 8) · Performance status 0, 1 or 2 (WHO performance scale – see Appendix 5) · Age >18 years · Life expectancy >12 weeks · Adequate haematological function: haemoglobin *10g/dl; WBC *3.0 x 109/L; absolute neutrophil count (ANC) *1.5 x 109/L; platelet count *100,000/mm3 · Creatinine clearance: >60ml/min (Wright, see Appendix 6) or >70ml/min (51Cr-EDTA) · Hepatobiliary function: Bilirubin <1.5xULN, Alkaline phosphatase, AST <3.0xULN or <5xULN in the presence of liver metastases · Patient compliance and geographic proximity that allows adequate follow-up · Able and willing to participate in the quality of life assessment · Written informed consent
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E.4 | Principal exclusion criteria |
· Prior chemotherapy or radiotherapy, however prior surgical resection is allowed, provided no neoadjuvant or adjuvant chemotherapy was given · Evidence of severe or uncontrolled systemic diseases that in the view of the investigator, makes it undesirable for the patient to participate in the trial · Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the trial · Concomitant or previously malignancy likely to interfere with protocol treatment or comparisons · Pre-existing neuropathy grade >2 · Clinical apparent metastatic disease to brain · Unresolved toxicity or incomplete recovery from previous surgery · Psychiatric disorder making reliable informed consent impossible or that might prevent completion of treatment or follow-up · Previous investigational agent in the last 12 weeks · Male and female patients (of childbearing age) not using adequate contraception · Female patients who are pregnant or breast-feeding
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
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 | 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) | Yes |
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 | 80 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | Yes |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |