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Trial record 2 of 7 for:    x-396

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

This study is currently recruiting participants.
Verified May 2017 by Xcovery Holding Company, LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT02767804
First Posted: May 10, 2016
Last Update Posted: May 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Xcovery Holding Company, LLC
  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.

Condition Intervention Phase
Non-small Cell Lung Cancer Drug: X-396 (ensartinib) Drug: crizotinib Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Xcovery Holding Company, LLC:

Primary Outcome Measures:
  • Progression-free survival (PFS) as assessed by independent radiology review based on RECIST v. 1.1 criteria [ Time Frame: 36 months ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: 48 months ]
  • Objective response rate (ORR) based on independent radiology review [ Time Frame: 36 months ]
  • PFS based on investigator assessment [ Time Frame: 36 months ]
  • ORR based on investigator assessment [ Time Frame: 36 months ]
  • Time to response based on independent radiology review [ Time Frame: 36 months ]
  • Time to response based on investigator assessment [ Time Frame: 36 months ]
  • Duration of response based on independent radiology review [ Time Frame: 36 months ]
  • Duration of response based on investigator assessment [ Time Frame: 36 months ]

Other Outcome Measures:
  • CNS response rate based on independent radiology review [ Time Frame: 36 months ]
  • CNS response rate based on investigator assessment [ Time Frame: 36 months ]
  • Time to CNS progression [ Time Frame: 36 months ]
  • Percentage of patients with adverse events [ Time Frame: 36 months ]
  • Patient reported time to deterioration (TTD) as measured by EORTC C30/LC13 QoL questionnaire [ Time Frame: 36 months ]
  • Patient reported TTD as measured by Lung Cancer Symptom Scale (LCSS) [ Time Frame: 36 months ]
  • Patient reported health-related quality of life (HRQoL) as measured by EORTC C30/LC13 QoL questionnaire [ Time Frame: 36 months ]
  • Patient reported HRQoL as measured by LCSS [ Time Frame: 36 months ]
  • Plasma concentrations (Cmax) at participating sites [ Time Frame: 36 months ]
  • Plasma concentrations (Cmin) at participating sites [ Time Frame: 36 months ]

Estimated Enrollment: 402
Study Start Date: June 2016
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: X-396 (ensartinib)
Eligible patients with ALK+ NSCLC will receive oral X-396 (ensartinib) at 225mg QD with or without food until progression or unacceptable toxicity develops
Drug: X-396 (ensartinib)
oral ALK inhibitor
Active Comparator: crizotinib
Eligible patients with ALK+ NSCLC will receive oral crizotinib at 250mg BID with or without food until progression or unacceptable toxicity develops
Drug: crizotinib
oral ALK inhibitor
Other Name: Xalkori

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02767804


Contacts
Contact: Jolee D. Holt, RN 918-899-1012 jholt@optimalsites.net
Contact: Holly Hoefer, MSHC 918-899-1012 optimalcommunity@optimalsites.net

  Show 69 Study Locations
Sponsors and Collaborators
Xcovery Holding Company, LLC
  More Information

Responsible Party: Xcovery Holding Company, LLC
ClinicalTrials.gov Identifier: NCT02767804     History of Changes
Other Study ID Numbers: X396-CLI-301
First Submitted: April 30, 2016
First Posted: May 10, 2016
Last Update Posted: May 22, 2017
Last Verified: May 2017

Keywords provided by Xcovery Holding Company, LLC:
ALK-positive NSCLC

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Crizotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action