Feasibility Study to Estimate Number of Patients With Precancerous Areas in Their Airways and the Response to Gefitinib

Exclusion Criteria

• •Diagnosis of any second malignancy within the 5 years from date of enrolment, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for 12 months
• •Evidence of severe or uncontrolled systemic disease or psychiatric disorder that would interfere with the patient's safety
• •Known severe hypersensitivity to Gefitinib or any of the excipients of the product
• •Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease
• •Pre-existing idiopathic pulmonary fibrosis
• •History of allergy to contrast medium
• •Insufficient lung function as determined by either clinical examination or an arterial oxygen tension (PaO2) of \< 9.3kpa
• •Inability to swallow oral medications
• •Presence of active inflammatory bowel disease, partial or complete bowel obstruction or chronic diarrhoea or any condition which would interfere with absorption of an oral drug.
• •Past medical history of keratitis
• •Past medical history of Sjogren's syndrome
• •Pregnant or breast-feeding
• •Male and female patients (of childbearing age) not using, or not willing to use, protocol mandated contraception
• •Prior EGFR inhibitor use.
• •Concurrent medication with known potent CYP3A4 inhibitors and inducers and/or dosing within 7 days of date of enrolment (e.g.. ketoconazole, rifampin, phenytoin, carbamazepine, barbiturates or herbal preparations containing St John's wort/Hypericum perforatum etc.) or use of other concomitant medication incompatible with study drug (see SmPC)
• •Current treatment on another therapeutic clinical trial or previous investigational agent in the last 12 weeks (supportive care trials or non-treatment trials are allowed)
• •Previous enrolment or treatment in the present study.