A Study Comparing X-396 (Ensartinib) to Crizotinib in Patients with ALK Positive Non-Small Cell Lung Cancer


About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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
  • May have received up to 1 prior chemotherapy regimen, which may also include maintenance therapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 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
  • Women of child-bearing potential who agree to use adequate contraceptive measures and have a negative serum or urine pregnancy test
  • Must be at least 18 years of age
  • Must have measurable disease per RECIST v. 1.1
  • Must be ALK-positive by IHC
  • Willing and able to comply with the trial and follow-up procedures
  • Able to understand the nature of this trial and give written informed consent

Exclusion Criteria

  • Previously received an ALK TKI
  • 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
  • Major surgery or radiotherapy within the last 14 days
  • Has primary CNS tumors or leptomeningeal disease 
  • Has had 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
  • Receiving strong CYP3A inhibitors or inducers
  • 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
  • Immunosuppressed (including known HIV infection)
  • Has a serious active infection at the time of treatment
  • Has interstitial lung disease or pneumonitis
  • Has any serious underlying medical condition that would impair ability to receive protocol treatment
  • Any psychological, familial, sociological, or geographical condition that does 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Helen Ross, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office


More information


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