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Study to Investigate the Efficacy and Safety of WX-0593 in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients

Sponsor
Qilu Pharmaceutical Co., Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05801107
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
25.7
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of this study is to evaluate the efficacy and safety of WX-0593 in patients with ALK-positive NSCLC

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study to Investigate the Efficacy and Safety of WX-0593 in Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Patients
Actual Study Start Date :
Oct 25, 2021
Anticipated Primary Completion Date :
Jul 15, 2023
Anticipated Study Completion Date :
Dec 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: WX0593

60 mg of WX-0593 tablets, once daily for 7 days, followed by 180 mg of WX-0593 tablets, once daily in a 21-days cycle.

Drug: WX-0593
WX-0593 Tablets 60 mg QD，once daily for 7 days, followed by 180 mg of WX-0593 tablets,once daily in a 21-days cycle.
Other Names:
  • FL-006

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate (ORR) Assessed By independent radiology review [From first administration to the date that the last patients observed for 18 weeks]

      ORR is defined the percentage of the participants who have achieved complete response (CR) or partial response (PR) per independent radiology review using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    • ≥18 years

    • Female or male

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

    • Life expectancy of at least 12 weeks

    • At least one measurable lesion

    • Histologically or cytologically confirmed diagnosis of advanced or recurrent or metastatic NSCLC that is ALK-positive by grade A tertiary hospitals, and subjects should have disease progression (RECIST 1.1) or intolerance (stopping criteria according to drug insert) after 1 or 2 marketed ALK inhibitors, the patients had disease progression after ALK inhibitor should continuously have drug at least 12 weeks , and less than 3 chemotherapy regimens previously

    • 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

    Key Exclusion Criteria:

    • Crizotinib is the only ALK inhibitor subjects received;unmarketed ALK inhibitor received; Lorlatinib or Brigatinib received; active ingredient or generic drug of ALK inhibitors received

    • HBsAg-positive and/or HBcAb positive and HBV DNA > 1000 copies/mL, or HCV antibody-positive, or known HIV infected

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Jiao Tong University Chest Hospital Shanghai China

    Sponsors and Collaborators

    • Qilu Pharmaceutical Co., Ltd.

    Investigators

    • Study Chair: Baohui Han, PhD, Shanghai Jiao Tong University Chest Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qilu Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT05801107
    Other Study ID Numbers:
    • WX0593-007
    First Posted:
    Apr 6, 2023
    Last Update Posted:
    Apr 6, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Apr 6, 2023