Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Phase I/II, Multicenter, Open-label, Single-arm Study of LDK378, Administered Orally in Adult Chinese Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib Study Type: Interventional
A single-Arm, open-label, multi-center, phase I/II study in which the pharmacokinetics, safety, tolerability and efficacy of LDK378 will be assessed in adult Chinese patients with locally advanced or metastatic NSCLC harboring a confirmed ALK rearrangement. Patients must have demonstrated progression during or after crizotinib treatment whether or not previously treated with cytotoxic chemotherapy. Approximately 100 patients will be enrolled. For the first 15 patients enrolled in this study, patients will have an additional 5-day PK run-in period before treatment period. The pharmacokinetics profile of LDK378 in Chinese adult patients with ALK-rearranged NSCLC will be evaluated.
This is a phase I/II, open-label, multi-center study in which the PK, safety, tolerability
and efficacy of LDK378 will be assessed in adult Chinese patients with locally advanced or
metastatic NSCLC harboring a confirmed ALK rearrangement (positive) as assessed using the
Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) or positive as assessed by
immunohistochemistry (IHC) test (Ventana Medical Systems, Inc) using rabbit monoclonal
primary antibody assay (D5F3).
Patients must have demonstrated progression during or after crizotinib treatment whether or
not previously treated with cytotoxic chemotherapy.
Approximately 100 patients with locally advanced or metastatic NSCLC which carry ALK
-rearrangement will be enrolled in the study. The first 15 patients to be enrolled in the
study will have PK sampling over 120-hour during the 5-day PK run-in period following a
single oral dose at 750 mg. After the PK run-in period, the treatment period will start in
which LDK378 will be given starting on Cycle 1 Day 1 in a continuous daily oral dosing in
28-day cycles. Separated from these 15 patients, the rest of the enrolled patients will
receive LDK378 treatment at 750 mg QD on Cycle 1 Day 1.
Tumor response will be evaluated every 8 weeks (i.e. every 2 cycles) starting from the first
day of treatment with LDK378 until the time of RECIST-defined PD by investigator assessment,
withdrawal of consent for further follow-up, loss to follow-up or death.
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