Patients with advanced NSCLC not previously treated with chemotherapy
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with histological documented, locally advanced or recurrent (stage IIIB and not amenable for combined modality treatment) or metastatic (Stage IV) NSCLC who have not received prior chemotherapy for advanced disease. - Formalin-fixed, paraffin-embedded primary diagnosis lung tumour tissue samples (tissue blocks are preferred over slides) representative of the tumour and collected prior to starting erlotinib therapy will be provided to the co-ordinating investigator. This Is A Mandatory Requirement For Study Entry. Tissue blocks/slides from each site should be sent prior to, or promptly following, the final patient ongoing at that site completing study treatment. HOWEVER, SLIDES ALSO MUST BE SENT WITHIN THREE WEEKS OF PREPARATION. - No prior chemotherapy for advanced disease. Previous adjuvant treatment is permitted if patient relapsed >= 1 year after the end of the chemotherapy. - Measurable disease according to RECIST. - Age 18 or greater. - Able to comply with study and follow-up procedures. - Patients must be able to take oral medication. - Written (signed) Informed Consent (WIC) to participate in the study. - ECOG performance status of 0 - 2. - Life expectancy of at least 12 weeks. - At least 4 weeks since any prior surgery or radiotherapy. Patients must have recovered (CTC 1,500/mm3 and platelet count > 100,000/mm3; Haemoglobin >= 9.0g/dl. - Serum bilirubin within upper limit of normal (ULN), SGOT (AST) and SGPT (ALT) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Any unstable systemic disease including: o active infection or serious underlying medical condition that would impair the ability of the patient to receive protocol treatment, o uncontrolled hypertension, o unstable angina, o severe heart disease (NYHA stages III and IV heart failure, unstable angina, uncontrolled arrhythmia in particular) o congestive heart failure, o history of myocardial infarction within the previous year, o serious cardiac arrhythmia requiring medication, o hepatic, renal or metabolic disease, - Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer). - Patients are excluded if they have 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 (clinically stable imaging) for at least 2 months will also cause patients to be excluded. - Any diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the study medication. - Previous treatment with any therapy which acts on the EGFR axis. - Patients unable to take oral medication, requiring intravenous alimentation, who have malabsorption syndrome or any other condition affecting gastrointestinal absorption, or who have active peptic ulcer disease. - Nursing and/or pregnant women. - Any inflammatory changes of the surface of the eye.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of erlotinib administered as a single agent to chemo-naïve NSCLC patients as determined by the Non Progression Rate (NPR) at 8 weeks. The evaluation will be done in the group of never smokers and current/former smokers separately. ; Secondary Objective: 1. To assess the Secondary efficacy parameters as determined by • the objective response rate and disease control rate • duration of response • time to progression • progression free survival • overall survival 2. To assess biomarker data on tumour specimen collected prior to erlotinib therapy and correlate with erlotinib treatment outcome 3. To prospectively evaluate the PK parameters potentially influencing erlotinib activity in never-smoker and current/former smoker group; 4. To study safety and tolerability of erlotinib in a first-line setting. ; Primary end point(s): The two treatment groups in this study will be evaluated separately; no statistical comparison of the results in the two treatment groups is planned. The primary efficacy variable is the Non Progression Rate (NPR). The NPR is defined as the proportion of patients without progressive disease (PD) (based on RECIST criteria) at 8 weeks after start of treatment, i.e., all patients with either a complete response (CR), partial response (PR), or stable disease (SD) that is documented for at least 8 weeks from baseline. | — |
Countries
Germany, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed