Study Comparing WX-0593 to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients

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Brief Title

Study Comparing WX-0593 to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients

Official Title

An Open-label, Randomized, Multicenter Phase 3 Study Comparing WX-0593 to Crizotinib in Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Patients

Brief Summary

      The primary purpose of this study is to evaluate the efficacy and safety of WX-0593 vs.
      crizotinib in patients with ALK-positive non-small cell lung cancer who had not received
      prior systemic therapy
    

Detailed Description

      To evaluate the efficacy and safety of WX-0593 vs. crizotinib in patients with ALK-positive
      NSCLC who had not received prior systemic therapy, to obtain additional pharmacokinetic (PK)
      data from sparse PK sampling, to compare the quality of life (QoL) in patients receiving
      WX-0593 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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Progression-free Survival (PFS)

Secondary Outcome

 Progression-free survival (PFS)

Condition

Non-small Cell Lung Cancer

Intervention

WX-0593 Tablets

Study Arms / Comparison Groups

 WX-0593 Tablets
Description:  Eligible patients with ALK+ NSCLC will receive WX-0593 tablets without food until documented disease progression or unacceptable toxicity. 60 mg of WX-0593 tablets, once daily for 7 days, followed by 180 mg of WX-0593 tablets, once daily in a 28-days cycle.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

330

Start Date

June 1, 2019

Completion Date

December 1, 2021

Primary Completion Date

June 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          1. ≥18 years

          2. Female or male

          3. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

          4. Life expectancy of at least 12 weeks.

          5. At least one measurable lesion (according to RECIST v1.1)

          6. Histologically or cytologically confirmed diagnosis of advanced or recurrent or
             metastatic NSCLC that is ALK-positive by an Abbott FISH assay in the central lab.
             Randomization will occur after ALK positive confirmation is received from the central
             lab or local test using an method including Abbott FISH、RT-PCR or Ventana IHC.

          7. No brain metastasis, or asymptomatic brain metastasis, or symptomatic brain metastasis
             but stable for more than 4 weeks after treatment, and have stopped systemic hormone
             treatment (prednisone of > 10 mg/day or equivalent hormone) for more than 2 weeks

          8. Patients must have normal function as defined: ANC≥1.5*10^9/L; PLT≥90*10^9/L, Hb≥90
             g/L, Total Bilirubin (TBIL)≤1.5*Upper Limit of Normal(ULN) ( Gilbert's Syndrome TBIL
             ≤3.0*ULN and DBIL≤1.5*ULN ),Alanine Transaminase (ALT)and Aspartate
             Aminotransferase(AST)≤2.5*ULN. For liver metastasis patients, ALT and AST≤5*ULN,
             Cr≤1.5*ULN, LVEF≥50%.

          9. Any surgery or prior radiation (expect for palliative radiation) /operations must have
             been completed at least 4 weeks prior to first dosing. Palliative radiation must have
             been completed at least 48 hours prior to first dosing.

         10. Patients must be able to understand and volunteer to sign the informed consent.

        Exclusion Criteria:

          1. Patients that have previously received cancer therapy (i.e., other targeted therapies,
             chemotherapy, immunotherapy, biologic therapy, hormonal therapy).

          2. Patients with tumor meningeal metastasis

          3. Clinically significant cardiovascular disease within 6 months prior to first dosing.

          4. Two consecutive corrected QT interval (QTc) > 480 ms through ECG examination during
             screening, ≥2 arrhythmias, ≥2 heart failure (according to CTCAE 4.03), atrial
             fibrillation and ventricular fibrillation of any grade, or clinically significant
             supraventricular or ventricular arrhythmia requiring treatment or intervention

          5. Patients need medications that may prolong QT interval or induce torsades de pointes
             within 14 days prior to the first dosing or during the study.

          6. Continuous use of corticosteroids for more than 30 days, or require chronic use of
             corticosteroids or other immunosuppressants

          7. Past history of a large area of diffuse/interstitial pulmonary fibrosis, or known
             history of Grade 3 or 4 interstitial pulmonary fibrosis or interstitial lung disease.

          8. Patients with Grade > 1 nausea, vomiting, or diarrhea (CTCAE 4.03), other GI
             dysfunction or GI disease that may potentially affect drug absorption.

          9. Patients at risk for GI perforation or intestinal obstruction

         10. Patient has received other investigational drug within 1 month prior to first dosing.
             Subject received other clinical trial treatment within 1 month prior to the first dose
             of the investigational drug.

         11. Patients who are HBsAg-positive and/or HBcAB positive and HBV DNA > 103copies/mL, or
             HCV antibody-positive, or syphilis antibody- positive or known HIV infected.

         12. Patients who cannot suspend the use of a strong CYP3A4 inducer or inhibitor at least 1
             weeks prior to this study and during the study.

         13. Patients who cannot suspend the use of a CYP3A4 substrate at least 1 weeks prior to
             this study and during the study, and the therapeutic index is low.

         14. Females who are pregnant or breastfeeding. Pregnant or lactating female patients or a
             positive pregnancy test at baseline for females of childbearing potential.

         15. Female patients who are unwilling to use effective contraceptive measures during the
             entire course of the study and within 6 months after the end of the study, or male
             patients who plan to have children.

         16. Concurrent diseases that may seriously affect patient safety or impact patient
             completion of the study as determined by the investigator (such as clinically
             uncontrolled hypertension (blood pressure > 160/110 mmHg), severe diabetes, or thyroid
             disease).

         17. Drug abusers and alcoholics. Drug or alcohol abuse. Alcohol abuse refers to drinking
             14 units of alcohol per week: 1 unit = 285mL of beer, or 25mL of spirits, or 100mL of
             wine;

         18. History of definitive neurological or mental disorder, including epilepsy or dementia

         19. Patients with other malignant tumors within 5 years prior to screening (except for
             cured basal cell carcinoma of the skin, cervical carcinoma in situ, thyroid carcinoma
             in situ, and papillary thyroid carcinoma).

         20. Patients with added risks associated with the study or may interfere with the
             interpretation of study results as determined by the investigator, or deemed
             unsuitable by the investigator and/or sponsor.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 0531-83129659, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04632758

Organization ID

WX0593-004


Responsible Party

Sponsor

Study Sponsor

Qilu Pharmaceutical Co., Ltd.


Study Sponsor

, , 


Verification Date

March 2020