Iressa Re-challenge in Advanced NSCLC EGFR-mutated Patients

Exclusion Criteria

• •Known severe hypersensitivity to gefitinib or any of the excipients of the product treatment with no persistent radiation toxicity. Previous adjuvant chemotherapy is allowed.
• •Progressive disease or stable disease (SD) \<12 weeks as best response to the 1st line treatment with an EGFR-TKI
• •Consideration to require radiotherapy to the lung at the time of study entry or in the near future
• •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 evidenced by CT scan at baseline
• •Known or suspected brain metastases or spinal cord compression, unless treated with surgery and/or radiation.
• •Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
• •Concomitant use of known CYP 3A4 inducers such as phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
• •Pregnancy or breast-feeding
• •As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
• •Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
• •Other co-existing malignancies or malignancies diagnosed within the last 2 years with the exception of basal cell carcinoma or cervical cancer in situ
• •Life expectancy of less than 12 weeks
• •Treatment with a non-approved or investigational drug within 30 days before day 1 of study treatment
• •Involvement in the planning and/or conduct of the study (applies to both NVALT staff or staff at the study site)
• •Previous enrolment or treatment in the present study.