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Trial Title:
Study to Investigate the Efficacy and Safety of WX-0593 in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients
NCT ID:
NCT05801107
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
WX-0593
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.
Arm group label:
WX0593
Other name:
FL-006
Summary:
The primary purpose of this study is to evaluate the efficacy and safety of WX-0593 in
patients with ALK-positive NSCLC
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Jiao Tong University Chest Hospital
Address:
City:
Shanghai
Country:
China
Start date:
October 25, 2021
Completion date:
December 15, 2023
Lead sponsor:
Agency:
Qilu Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Qilu Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05801107
