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

Primary Purpose

Non-small Cell Lung Cancer

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
WX-0593
Sponsored by
Qilu Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Jiao Tong University Chest Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WX0593

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) Assessed By independent radiology review
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.

Secondary Outcome Measures

Full Information

First Posted
March 24, 2023
Last Updated
March 24, 2023
Sponsor
Qilu Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05801107
Brief Title
Study to Investigate the Efficacy and Safety of WX-0593 in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
July 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WX0593
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
WX-0593
Other Intervention Name(s)
FL-006
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) Assessed By independent radiology review
Description
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.
Time Frame
From first administration to the date that the last patients observed for 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baohui Han, PhD
Organizational Affiliation
Shanghai Jiao Tong University Chest Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Jiao Tong University Chest Hospital
City
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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