LDK378 Study

Full Name

Non-Small Cell Lung Cancer/ CLDK378A2402: An open-label, multi-center, Expanded Treatment Protocol (ETP) of oral LDK378 in adult patients with non-small cell lung cancer (NSCLC) characterized by ALK positivity (1_PRO00001585)

Description

LDK378 is called a â€œtargetedâ€ medicine, which means it targets particular processes which are not working. Patients who choose to take part will receive LDK378 (5 capsules of 150 mg of LDK378, once daily for a total of 750 mg daily). Patients will be asked to come to the study doctorâ€™s study site in cycles of 21 days. During the first two cycles, there will be one visit on Day 1, which can take between 6-7 hours. For subsequent cycles, there will be a visit on Day 1, which will take approximately 1-2 hours. Patients will continue to take LDK378 as long as they benefit from the treatment, or until their disease gets worse or they experience too many side effects. If participants are taking medications that interact with LDK378, they will need to be stopped.

Eligibility

Inclusion Criteria

Must be 18 years of age or older
Must have a WHO performance status 0-3
Must have stage IIIB or IV non-small cell lung cancer with documented disease progression at enrollment, and does not qualify or have access to LDK378 through a clinical trial
Must not have known hypersensitivity to any of the components of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)
Must not have had prior therapy with LDK378
Must not have had major surgery within 4 weeks prior to starting LDK378