NCT01579994

Who might be able to join this trial:

• You have been diagnosed with advanced lung adenocarcinoma (a specific type of lung cancer) that has spread locally or to other parts of the body (stage III or IV), confirmed by testing at MSKCC.
• Your cancer has tested positive for a specific gene change involving the ALK gene (detected by standard lab tests such as FISH or IHC).
• You have never been treated with the drug crizotinib, though previous chemotherapy is allowed.
• You are 18 years of age or older.
• You have at least one area of cancer that can be measured on a scan and has not previously been treated with radiation.
• You are in reasonably good general health, able to carry out normal daily activities with some effort (Karnofsky score of 70% or higher).
• You are able to swallow and digest oral medications (pills or capsules).
• If you are a woman who could become pregnant, you must have a negative pregnancy blood test within two weeks before starting the study drugs.
• All women who could become pregnant and all sexually active men must agree to use effective birth control throughout the study.

Who may not be able to join:

• You have previously been treated with the drug crizotinib.
• You are still experiencing significant side effects from a previous cancer treatment that have not recovered to a mild or baseline level.
• Your blood cell counts are too low — specifically, low white blood cells, low platelets, or low red blood cells (confirm with trial site for exact numbers).
• Your liver function blood tests are significantly above the normal range (confirm with trial site for exact thresholds).
• Your kidney function blood test (creatinine) is more than twice the upper limit of normal.
• You have an active infection (bacterial, viral, fungal, or other) that is not improving with appropriate treatment.
• You have brain metastases (cancer that has spread to the brain) that are currently active and require treatment with steroids or radiation — however, brain metastases that have been stable for at least two weeks may be acceptable.
• You have serious heart disease, such as severe heart failure, a heart attack within the past 6 months, unstable chest pain (angina), recent heart procedures, or an uncontrolled irregular heartbeat.
• You have had another type of cancer in the last 2 years, with some exceptions such as certain treated skin cancers, cervical carcinoma in situ, or prostate cancer not requiring active treatment.
• You are currently pregnant or breastfeeding.
• You are taking certain medications or foods known to strongly affect how the study drugs are processed by the body (CYP3A4 inhibitors or inducers — confirm with trial site for specific substances).
• You have any other condition that, in the study doctor's opinion, could affect your safety or ability to complete the trial.

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