Non-small Cell Lung Cancer
Conditions
Brief summary
The primary purpose of this study is to evaluate the efficacy and safety of WX-0593 in patients with ALK-positive NSCLC
Interventions
DRUGWX-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.
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed