None listed
Conditions
Interventions
Drug : The treatment period begins on Day 1 of Cycle 1 and 1 cycle consists of 28 days.
All patients will be treated with LDK378 750mg daily (PO)
Patients will be continued to receive study drug until
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Subjects with histologically or cytologically confirmed, stage IV or recurrent NSCLC that carries a ROS1 rearrangement, as per FISH assay (Abbott Molecular Inc.) ? ECOG performance status of 0 to 2 ? Male or female; = 20 years of age ? Subjects must have received at least 1 platinum doublet to treat their stage IV or recurrent NSCLC ? Subjects whose disease has progressed within 6 months Subjects with measurable lesion (using RECIST 1.1 criteria) ? Subjects must have recovered from all toxicities related to prior anticancer therapies to grade = 2 ? Subjects must have archival tissue sample available, collected either at the time of diagnosis of NSCLC or any time since ? Subjects who meet the following criteria: - Absolute neutrophil count (ANC) ? 1.5 x 109/L - Platelet count ? 100 x 109/L - Serum creatinine ? 1.5 x upper limit of normal (ULN) - AST (SGOT) and ALT (SGPT) ? 3 x upper limit of normal (ULN) (If there is Liver Metastasis ? 5 x upper limit of normal (ULN)) - Total bilirubin ? 1.5 x upper limit of normal (ULN) ? Provision of written informed consent prior to any study specific procedures
Exclusion criteria
Exclusion criteria: ? Any unresolved chronic toxicity greater than CTC grade 3 from previous anticancer therapy. ? Any major operation or irradiation within 4 weeks of baseline disease assessment ? Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug ? Subjects 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 ? Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma or cervical cancer in situ. ? Subjects with an uncontrolled major cardiovascular disease (including AMI within 12 months, unstable angina within 6 months, over NYHA class III congestive heart failure, congenital long QT syndrome, 2° or more AV Block and uncontrolled hypertension) ? Pregnant or lactating female ? Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study ? Patients with known history of extensive disseminated bilateral interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and clinically significant radiation pneumonitis (i.e. affecting activities of daily living or requiring therapeutic intervention). ? Receiving medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with LDK378 and for the duration of participation -Medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes -Medications with a low therapeutic index that are primarily metabolized by CYP3A4/5, CYP2C8 and/or CYP2C9 ? Patients who did not receive chest radiotherapy at the lung site prior to the initiation of clinical trial therapy = <4 weeks, or who did not recover from radiation therapy-related toxicity. For all other anatomical sites (including radiotherapy for thoracic and rib fractures, GKS, and WBRT), patients who received radiation therapy prior to the initiation of clinical trial therapy <2 weeks or who received radiotherapy Patients who have not recovered from therapy-related toxicity. Palliative radiotherapy for bony lesions is allowed at =<2 weeks prior to initiation of clinical trial treatment. ? Patients using crizotinib
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall Survival;Duration of response;disease control rate;Safety of LDK378 | — |
Countries
Korea, Republic of
Contacts
Public ContactYuri Kang
Yonsei University Health System, Severance Hospital
Outcome results
None listed