Clinical Trials /

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

NCT02767804

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients
  • Official Title: Phase 3 Randomized Study Comparing X-396 (Ensartinib) to Crizotinib in Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Patients

Clinical Trial IDs

  • ORG STUDY ID: X396-CLI-301
  • NCT ID: NCT02767804

Conditions

  • Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
X-396 (ensartinib)X-396 (ensartinib)
crizotinibXalkoricrizotinib

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
X-396 (ensartinib)ExperimentalEligible patients with ALK+ NSCLC will receive oral X-396 (ensartinib) at 225mg QD with or without food until progression or unacceptable toxicity develops
  • X-396 (ensartinib)
crizotinibActive ComparatorEligible patients with ALK+ NSCLC will receive oral crizotinib at 250mg BID with or without food until progression or unacceptable toxicity develops
  • crizotinib

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival (PFS) as assessed by independent radiology review based on RECIST v. 1.1 criteria
Time Frame:36 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall survival (OS)
Time Frame:48 months
Safety Issue:
Description:
Measure:Objective response rate (ORR) based on independent radiology review
Time Frame:36 months
Safety Issue:
Description:
Measure:PFS based on investigator assessment
Time Frame:36 months
Safety Issue:
Description:
Measure:ORR based on investigator assessment
Time Frame:36 months
Safety Issue:
Description:
Measure:Time to response based on independent radiology review
Time Frame:36 months
Safety Issue:
Description:
Measure:Time to response based on investigator assessment
Time Frame:36 months
Safety Issue:
Description:
Measure:Duration of response based on independent radiology review
Time Frame:36 months
Safety Issue:
Description:
Measure:Duration of response based on investigator assessment
Time Frame:36 months
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Xcovery Holding Company, LLC

Trial Keywords

  • ALK-positive NSCLC

Last Updated

May 19, 2017