Advanced (stage IIIb and IV) non small cell lung cancer
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically / cytologically documented advanced (Stage IIIB and IV) NSCLC where tumour tissue is accessible to biopsy via bronchoscopy. -Measurable disease according to RECIST criteria. -Failure of at least one prior regimen of standard chemotherapy or patients who are deemed unsuitable for chemotherapy in the investigators opinion or who are unwilling to undergo chemotherapy. -ECOG performance status of 0 - 2. -Life expectancy of at least 12 weeks. -At least 4 weeks since any previous surgery or radiotherapy. -Granulocyte count > 1,500/mm3 and platelet count > 100,000/mm3; Haemoglobin > or = 9.0 g/dL. - SGOT (AST) and SGPT (ALT) or = 2.5 x ULN, SGOT (AST) and SGPT (ALT) must be or = 2.5 x ULN in the presence of liver metastases, SGOT and SGPT must be 60 ml/min. -Normal serum calcium. -Patient must be willing and able to undergo a bronchoscopy with biopsies according to the institute’s own guidelines and requirements for such procedures. -Coagulation parameters (PTT, INR) must be within normal range. -Platelet aggregation inhibitors must discontinued within an appropriate time period before bronchoscopy. -Male and female patients with reproductive potential must use reliable means of contraceptive Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding likely to affect the evaluation of the study or place the patient at risk whilst on Tarceva treatment or puts the patient at incalculable risk during biopsy. -Any other malignancies within the last 5 years before study start (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer). -Clinical evidence of brain metastasis, or have brain metastasis or spinal cord compression that is newly diagnosed and/or has not yet been definitively treated with surgery and/or radiation; previously diagnosed and treated CNS metastases or spinal cord compression without evidence of stable disease for at least 2 months will also cause patients to be excluded. -Previous treatment with any therapy which acts on the EGFR axis. -Any known significant ophthalmologic abnormalities of the surface of the eye. -Patients using coumadin or warfarin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Gene expression profiles in tumour tissue and normal cells. Gene mutation analysis for EGFR and other molecules involved in EGFR signal transduction;Main Objective: The primary objective is the identification of differentially expressed genes that are predictive for benefit of Tarceva treatment. ;Secondary Objective: The secondary objectives are to assess alterations in the EGFR signalling pathways with respect to benefit from treatment. | — |
Countries
Estonia, Germany, Ireland, Italy, Spain, United Kingdom
Outcome results
None listed