NCT00452244

Who might be able to join this trial:

• You have been diagnosed with non-small cell lung cancer (NSCLC), confirmed by a lab test on a tissue or cell sample
• Your cancer is at an advanced stage (Stage IV, or Stage IIIB with fluid around the lungs or multiple spots in the same lung)
• You have already received at least one chemotherapy treatment that included a platinum-based drug
• It has been at least 21 days since your last chemotherapy treatment
• You have had radiation therapy before, as long as there is at least one other area of cancer that can be measured
• You have stopped any other cancer treatments (such as radiation or immunotherapy) for at least 2 weeks before joining the study
• Your general health and ability to carry out daily activities falls within an acceptable range (confirm with trial site)
• You have at least one measurable area of cancer that can be tracked during the study
• Your life expectancy is at least 8 weeks
• You are willing and able to attend follow-up appointments as required
• Your blood counts, liver function, and kidney function are within acceptable levels (confirm with trial site)
• You are at least 18 years old
• If you are a woman who could become pregnant, you are using an approved form of contraception (such as the pill, an IUD, or a barrier method) during the study and for 3 months after, and you have had a negative pregnancy test within 7 days of starting the study
• If you are a man, you are willing to use an approved contraceptive method during the study and for 3 months after
• You are not currently taking certain medications including cyclosporin A, valproic acid, phenobarbital, phenytoin, or ketoconazole
• You have cancer that has spread to the brain, as long as you do not have significant neurological symptoms (confirm with trial site)

Who may not be able to join:

• You have small-cell lung cancer (either alone or alongside NSCLC)
• You still have unresolved lasting side effects from a previous cancer treatment
• You have a known severe allergy to gefitinib or any of its ingredients
• You are unable to swallow tablets
• You have another type of cancer (other than a common type of skin cancer called basal-cell carcinoma)
• You have already had more than three different chemotherapy treatments for NSCLC
• You have previously been treated with an experimental drug that works by blocking the same pathway this trial targets (EGFR inhibitors) (confirm with trial site)
• You are currently taking certain medications including phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
• You have a serious or uncontrolled illness
• You have an active lung condition called interstitial lung disease (with some exceptions — confirm with trial site)
• You have had a heart attack in the last 6 months, or have an unstable heart condition such as angina, heart failure, or uncontrolled irregular heartbeat
• You have a serious active infection, including a type of pneumonia linked to a blocked airway
• You have had major surgery (other than a biopsy) within the last two weeks
• You are pregnant or breastfeeding

Important: Always verify eligibility with the trial site directly before applying.