E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with advanced (inoperable stage IIIB or stage IV) NSCLC |
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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 |
At undersøge effekten af Tarceva givet som 1. linie behandling til patienter, med avanceret NSCLC, der ikke er egnede til at modtage medicinsk behandling med kemoterapi målt ved den progressionsfri ratio (CR+PR eller SD efter 8 uger ) vurderet ved RECIST kriterierne |
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E.2.2 | Secondary objectives of the trial |
At undersøge tolerabiliteten og sikkerheden af Tarceva hos patienter, der ikke er egnede til anden medicinsk behandling
At undersøge om der kan påvises en korrelation mellem effekt af Tarceva og EGFR ekspressionen samt gen amplifikationen.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Histological or cytological documented diagnosis of inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) NSCLC. • Chemo-naïve patients. • Patients who are in the investigator’s opinion not medically suitable for chemotherapy. • Measurable disease according to the RECIST criteria. • ECOG performance status of 0 – 3. • Life expectancy of at least 12 weeks. • Patients must be able to take oral medication. • Serum calcium within normal ranges • ≥ 4 weeks since prior surgery • For all females of childbearing potential a negative pregnancy test must be obtained within 48 hours before starting therapy and must use effective contraception • 18 years of age or older • Written (signed) Informed Consent to participate in the study
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E.4 | Principal exclusion criteria |
• Prior systemic antitumor therapy • Any unstable systemic disease which according to the investigator contraindicates the use of the study drug render the subject at high risk from treatment complications (including active infection, unstable angina, myocardial infarction within the previous month, inflammatory bowel disease, hepatic disease with serum bilirubin ≥ 2 upper limit of normal (ULN) or AST and/or ALT ≥ 2 x ULN (or ≥ 5 x ULN if clearly attributable to liver metastasis), renal disease with acute renal failure or serum creatinine ≥ 5 x ULN. • Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer). • Nursing mothers or pregnant woman. • Hypersensitivity to Tarceva or co-formulants. • Patients with brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation. • Patients with brain metastasis or spinal cord compression that not are in a stable condition despite treatment with steroids.
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E.5 End points |
E.5.1 | Primary end point(s) |
• Disease control rate (= CR+PR and SD at 8 weeks /patients). |
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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 | 3 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |