Stage IIIb/IV non-small cell lung cancer (NSCLC) tumours that over-express EGFR MedDRA version: 9.1 Level: LLT Classification code 10025054 Term: Lung cancer non-small cell stage IIIB MedDRA version: 9.1 Level: LLT Classification code 10029522 Term: Non-small cell lung cancer stage IV
Conditions
Interventions
Trade Name: Tarceva
Product Name: Tarceva
Product Code: erotinib
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: erotinib
Sponsors
Oxford Radcliffe Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically or cytologically proven NSCLC, Stage IIIb/IV Immunocytochemical evidence of EGFR over expression (++ or +++) from diagnostic tissue (e.g. bronchoscopic tumour samples core biopsies, fine needle aspirates-FNA). Life expectancy of at least 12 weeks World Health Organisation (WHO) performance status of 0-2 Haematological and biochemical indices within the ranges shown below. These measurements must be performed within two weeks before the patient goes on study. Haemoglobin (Hb) =9.0 g/dl. Neutrophils =1.5 x 10 to the power 9/L. Platelets =100 x 10 to the power 9/L. Serum bilirubin =1.5 x upper normal limit. Aspartate amino-transferase (AST) = 2.5 x upper limit of normal (ULN). Calculated creatinine clearance =50 ml/min. 18 years or over Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up RECIST criteria measurable disease at baseline. Ability to take oral medication 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: Previously treated with combination chemotherapy as first line treatment of NSCLC. Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks. Current malignancies at other sites, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy and are deemed at low risk for recurrence, are eligible for the study. Known primary brain tumours or brain metastases. Ability to become pregnant (or already pregnant or lactating). However, those female patients who have a negative serum or urine pregnancy test before enrolment and agree to use appropriate medically approved contraception for four weeks before starting trial treatment, during the trial and for six months afterwards are considered eligible. At high medical risk because of non-malignant systemic disease including active uncontrolled infection. Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV). Any other condition which in the Investigator’s opinion would not make the patient a good candidate for the clinical trial. Anticoagulant, antifibrinolytic therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To document the anti-tumour activity of Erlotinib as first line therapy in patients with stage IIIb/IV NSCLC tumours that over-express Epidermal growth factor receptor (EGFR); Secondary Objective: To determine the progression free interval To determine median survival rates To assess the toxicity profile of Erlotinib in this population of patients To investigate the response to second line treatment To investigate the pharmacodynamic behaviour of Erlotinib in EGFR over-expressing NSCLC. To identify biomarkers that correlate with an early response to treatment. To compare EGFR expression in bronchial brushing samples with bronchial biopsy samples ;Primary end point(s): Tumour response rates at 12 weeks (CR or PR) determined by RECIST criteria | — |
Countries
United Kingdom
Outcome results
None listed