Expanded Access to Ensartinib for Participants With ALK+ NSCLC
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorXcovery Holdings, Inc.
About this trial
This is an open-label, multicenter, intermediate-sized expanded access treatment protocol to the existing IND 111,695 for ensartinib (X-396). The treatment plan is designed to provide ensartinib to participants with anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC).
Eligibility criteria
Qualifiers
Adult patients (>18 years-of-age) with advanced ALK-positive NSCLC as determined by an FDA approved test.
Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1.
Informed consent must be provided by each patient.
Patient is not eligible or does not have access for participation in any of the other ongoing clinical trials for ensartinib.
Disqualifiers
Patients currently receiving cancer therapy.
Use of an investigational or targeted drug within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of ensartinib. A minimum of 10 days between termination of the treatment and administration of ensartinib is required. However, in the case of ALK TKIs, a 2-day window between termination of the TKI and the start of ensartinib is allowed. In addition, any drug-related toxicity should have recovered to Grade 1 or less, with the exception of alopecia.
Any major surgery or immunotherapy within the last 21 days (focal radiation does not require a washout period; ≥4 weeks for whole brain radiotherapy). Chemotherapy regimens with delayed toxicity within the last 4 weeks (or within the last 6 weeks for prior nitrosourea or mitomycin C). Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity within the last 2 weeks.
Patients with a known allergy or delayed hypersensitivity reaction to drugs chemically related to ensartinib (e.g., crizotinib) or to the active ingredient of ensartinib or to tartrazine, a dye used in the ensartinib 100 mg capsules.
Trial design
Treatments tested in this trial
- Ensartinib
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov