SCCA Clinical Studies: Lung Cancer
|Closed||Non-Small Cell Lung Cancer||Phase II||
A single-arm, open-label, two-stage multicenter, phase II study. Patients will be pre-screened for ALK positive status. Treatment with LDK378 at 750 mg qd will continue until the patient experiences unacceptable toxicity that precludes further treatment, discontinues treatment at the discretion of the investigator or patient, starts a new anticancer therapy and/or dies. LDK378 may be continued beyond RECISTdefined PD as assessed by the investigator, if in the judgment of the investigator, there is evidence of clinical benefit. Patients who discontinue the study medication in the absence of progression will continue to be followed for tumor assessment until the time of PD as assessed by the investigator. Male and female patients aged 18 or over with ALK-rearranged NSCLC will be screened for eligibility. Patients must have received no prior crizotinib, but must have been pretreated with cytotoxic chemotherapy (1 to 3 prior lines, of which 1 must have been a platinum doublet).
- Histologically or cytologically confirmed diagnosis of stage IIIb or IV NSCLC that carries an ALK rearrangement, as per the FDA-approved Vysis ALK break-apart FISH assay (Abbott Molecular Inc.)
- Age 18 years or older at the time of informed consent.
- Patients must have NSCLC that has progressed during or after prior the last chemotherapy regimen received prior to the first dose of LDK378.
- 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 archival 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.
- Prior treatment with crizotinib, or any other ALK inhibitor investigational agent, for NSCLC
- 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.
- Clinically significant, uncontrolled heart disease.
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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