SCCA Clinical Studies: Lung Cancer
|Closed||Non-Small Cell Lung Cancer||Phase II||
A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 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 anti-cancer therapy and/or dies. LDK378 may be continued beyond RECIST-defined PD as assessed by the investigator if, in the judgment of the investigator, there is evidence of clinical benefit. In these patients tumor assessment should continue as per the schedule of assessments until treatment with LDK378 is permanently discontinued. 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.
- 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 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.
- 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
- Systemic anti-cancer therapy given after the last dose of crizotinib and prior to starting study drug.
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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