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Expanded Access to Ensartinib for Participants With ALK+ NSCLC

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ClinicalTrials.gov Identifier: NCT04146571
Expanded Access Status : Available
First Posted : October 31, 2019
Last Update Posted : March 3, 2022
Information provided by (Responsible Party):
Xcovery Holding Company, LLC

Brief Summary:
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).

Condition or disease Intervention/treatment
Non-Small Cell Lung Cancer ALK Gene Rearrangement Positive Drug: Ensartinib

Detailed Description:
Open-label, multi-center, intermediate-sized expanded access treatment protocol for X396-CLI-101 (Phase I/II, First-in-Human, Dose-Escalation Study of X-396 in Patients with Advanced Solid Tumors and Expansion Phase in Patients with ALK+ Non-Small Cell Lung Cancer)

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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
Official Title: Expanded Access Intermediate-Size Patient Population Protocol

Intervention Details:
  • Drug: Ensartinib
    Oral, ALK inhibitor
    Other Names:
    • X-396
    • X396

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  1. Adult patients (>18 years-of-age) with advanced ALK-positive NSCLC as determined by an FDA approved test.
  2. Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1.
  3. Informed consent must be provided by each patient.
  4. Patient is not eligible or does not have access for participation in any of the other ongoing clinical trials for ensartinib.
  5. Ability to swallow and retain oral medication.
  6. Male and female patients must agree to abstain or to use two highly effective forms of contraception during the treatment period and for 90 days after the last dose of study medication.
  7. Adequate organ system function.
  8. Patients with treated CNS metastases are eligible if they are asymptomatic with respect to the CNS metastases and do not require escalating doses of systemic corticosteroids. ALK-positive patients with untreated CNS lesions may be allowed to enroll as long as the patients are asymptomatic with respect to the CNS metastases and do not require systemic corticosteroids or anticonvulsants.

Exclusion Criteria:

  1. Patients currently receiving cancer therapy.
  2. 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.
  3. 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.
  4. 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.
  5. Patients receiving CYP3A substrates with narrow therapeutic indices, strong CYP3A inhibitors, and strong CYP3A inducers.
  6. Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of ensartinib.
  7. Clinically significant cardiovascular disease.
  8. Patients who are immunosuppressed (including known HIV infection), have a serious active infection at the time of treatment, have known hepatitis C, or have any serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
  9. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
  10. Have a history or the presence at baseline of pulmonary interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis.
  11. Females who are pregnant or breastfeeding.
  12. Patient with any concurrent condition or receiving any concurrent medication that, in the investigator's opinion, would impart excessive risk associated with study participation or otherwise make it inappropriate for the patient to participate.

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): NCT04146571

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Contact: Anthony Pierce 5618359356 ext 219 anthony@xcovery.com
Contact: Esteban Sanchez 5618359356 ext 217 clinicaltrials@xcovery.com

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United States, California
Stanford University Available
Stanford, California, United States, 94305
Contact: Danielle Pancirer    650-723-0186    dpancirer@stanford.edu   
Principal Investigator: Heather Wakelee, M.D.         
United States, Maryland
Walter Reed National Military Medical Center Available
Bethesda, Maryland, United States, 20889
Contact: Virginia Schmidt    301-295-6814    sonja.t.skeete.ctr@mail.mil   
Principal Investigator: Alden Chiu, M.D.         
United States, Tennessee
Vanderbilt University Available
Nashville, Tennessee, United States, 37240
Contact: Lara Edens    800-811-8480    lara.j.edens@vumc.org   
Principal Investigator: Sally York, MD         
United States, Wisconsin
University of Wisconsin Carbone Cancer Ctr Available
Madison, Wisconsin, United States, 53792
Contact: Kristen Schumacher    608-262-8158    ksschumache2@wisc.edu   
Principal Investigator: Anne Traynor, M.D.         
Sponsors and Collaborators
Xcovery Holding Company, LLC
Publications of Results:
Other Publications:
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Responsible Party: Xcovery Holding Company, LLC
ClinicalTrials.gov Identifier: NCT04146571    
Other Study ID Numbers: X396-CLI-205
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: March 3, 2022
Last Verified: February 2022
Keywords provided by Xcovery Holding Company, LLC:
anaplastic lymphoma kinase
ALK positive
Non-Small Cell Lung Cancer
ALK inhibitor
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action