Patient case: 18-year-old male with anaplastic large cell lymphoma; genetic feature: ALK

Clinical trial: eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients

Summary: The primary purpose of this study is to evaluate the efficacy and safety of X-396 (ensartinib) vs. crizotinib in patients with ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy regimen and no prior ALK inhibitor.

Detailed description: To evaluate the efficacy and safety of X-396 (ensartinib) vs. crizotinib in patients with ALK-positive NSCLC that have received up to 1 prior chemotherapy regimen and no prior ALK tyrosine kinase inhibitor (TKI), to obtain additional pharmacokinetic (PK) data from sparse PK sampling, to compare the quality of life (QoL) in patients receiving X-396 vs. crizotinib, to evaluate the status of exploratory biomarkers and correlate with clinical outcome, and to obtain germline DNA samples for possible pharmacogenetic analysis in the event that outliers with respect to efficacy, tolerability/safety, or exposure are identified.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive. Patients may have received up to 1 prior chemotherapy regimen, which may also include maintenance therapy.
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2.
  -  Life expectancy of at least 12 weeks.
  -  Ability to swallow and retain oral medication.
  -  Adequate organ system function.
  -  Brain metastases allowed if asymptomatic at study baseline.
  -  Men willing to use adequate contraceptive measures.
  -  Women who are not of child-bearing potential, and women of child-bearing potential who agree to use adequate contraceptive measures and who have a negative serum or urine pregnancy test.
  -  Patients must be at least 18 years of age.
  -  Patients must have measurable disease per RECIST v. 1.1.
  -  Patients must be ALK-positive by IHC.
  -  Willingness and ability to comply with the trial and follow-up procedures.
  -  Ability to understand the nature of this trial and give written informed consent.
  Exclusion Criteria:
  -  Patients that have previously received an ALK TKI, and patients currently receiving cancer therapy.
  -  Use of an investigational drug within 21 days prior to the first dose of study drug.
  -  Any chemotherapy within 4 weeks, or major surgery or radiotherapy within the last 14 days.
  -  Patients with primary CNS tumors and leptomeningeal disease are ineligible.
  -  Patients with a previous malignancy within the past 3 years.
  -  Concomitant use of drugs with a risk of causing Torsades de Pointes. -Concomitant use of herbal medications.
  -  Patients receiving strong CYP3A inhibitors or inducers.
  -  Women who are pregnant or breastfeeding.
  -  Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
  -  Clinically significant cardiovascular disease.
  -  Patients who are immunosuppressed (including known HIV infection), have a serious active infection at the time of treatment, have interstitial lung disease/pneumonitis, or have any serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
  -  Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
  -  Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol or would impart excessive risk associated with study participation that would make it inappropriate for the patient to be enrolled.
  -  Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.

Relevance to patient case: not relevant