Patients with advanced (inoperable stage IIIB or stage IV) NSCLC
Conditions
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: 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. ;Primary end point(s): • Disease control rate (= CR+PR and SD at 8 weeks /patients). | — |
Countries
Denmark
Outcome results
None listed