Advanced Non-small Cell Lung with EGFR Wild-Type Cancer Study (PRO00003058)

If you agree to take part in this research study, you will first be asked to join in a molecular testing procedure, which is the first portion of this research study, called molecular pre-screening. For the pre-screening, you will be asked to provide a sample of your tumor so that a Novartis-designated (Novartis is the sponsor of the study) laboratory can measure the gene copy number of a specific gene called c-MET on this tumor sample. The test can be done on a biopsy sample collected from you before your participation in this study (called an “archival” tumor sample – no operations or biopsies need to be done), or a newly obtained sample of your tumor. In addition, if you have not already had EGFR and ALK gene testing done, you will be asked to provide additional tumor tissue to be sent to the Novartis-designated laboratory to determine your ALK status along with your c-MET status. The results of these tests will determine whether you may continue with further evaluations to determine if you are eligible to participate in the main research study. If the tests show that you can be in the research study, and you choose to take part, you will be asked to take INC280 (either 4 tablets of 100 mg or 2 tablets of 200 mg, when available) 2 times per day with water. INC280 is not approved by the FDA. If you meet the entry criteria, you will be enrolled in one of four study groups depending on the presence of c-MET mutations and c-MET gene copy number in your tumor. The study treatment will be the same for all study groups. Starting on Day 1, you will take a 400 mg dose of INC280 (either 4 tablets of 100 mg or 2 tablets of 200 mg, when available), two times a day, every day: once in the morning and once in the evening, at approximately the same time. It is recommended that the morning and evening doses be taken 12 hours apart. You should take each dose at least 1 hour before or 2 hours after a meal. Do not crush, break or chew the pills. In this study, a treatment cycle is 21 days starting from Day 1 (first dose of study drug). You will be asked to come back to the doctor’s office/clinic twice during the first cycle (first 21 days) on Day 1 and Day 15, and then every 21 days thereafter from Day 1 so that your condition can be monitored. There will be various tests and procedures done throughout the study. The study doctor will review these in greater detail with you. In addition, biomarker studies will be done. Biomarkers can be measured from blood and tumor tissues. Biomarker samples will be collected before you start study treatment and at the time of disease progression so that the researchers can learn more about your cancer and assess whether the study treatment is having an effect on your cancer.