Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Inclusion critieria:
Histologically or cytologically confirmed diagnosis of stage IIIB or IV NSCLC that carries an ALK rearrangement, as per the FDA-approved FISH assay (Abbott Molecular Inc.).
Age 18 years or older at the time of informed consent.
Patients must have NSCLC that has progressed during therapy with crizotinib or within 30 days of the last dose
Patients must have received 1-3 lines of cytotoxic chemotherapy (of which 1 must have been a platinum doublet) to treat their locally advanced or metastatic NSCLC
Patients must have a tumor tissue sample available, collected either at the time of diagnosis of NSCLC or any time since.
Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 2, except for patients with grade 2 nausea/vomiting and/or grade 2 diarrhea despite optimal supportive therapy who will not be allowed to participate in the study.
You may not be if
Patients with known hypersensitivity to any of the excipients of LDK378.
Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
History of carcinomatous meningitis.
Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
