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Trial Title:
Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer
NCT ID:
NCT05765877
Condition:
Non-Small Cell Lung Cancer(NSCLC)
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet 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 Tablets
Description:
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.
Arm group label:
WX-0593
Summary:
This is a single-arm, exploratory trial to evaluate the efficacy and safety of
neoadjuvant WX-0593 in patients with resectable ALK-positive or ROS1- positive non-small
cell lung cancer(NSCLC).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed non-small cell lung cancer (NSCLC).
- ALK-positive or ROS1-positive NSCLC in Stage IB-IIIA (according to the 8th American
Joint Committee on Cancer TNM edition), as assessed by investigator.
- Complete surgical resection of the primary NSCLC must be deemed achievable, as
assessed by a MDT evaluation (which should include a thoracic surgeon, specialized
in oncologic procedures).
- ECOG Performance Status of 0-1.
- At least one measurable lesion according to RECIST 1.1.
- Adequate organ and marrow function.
Exclusion Criteria:
- Prior treatment with any systemic anti-cancer therapy for NSCLC including
chemotherapy, biologic therapy, immunotherapy, or any investigational drug.
- Prior treatment with ALK TKI or ROS1 TKI.
- Prior treatment with local radiotherapy.
- Mixed small cell and NSCLC histology.
- Patients who are candidates to undergo only segmentectomies or wedge resections.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shandong Cancer Hospital and Institute
Address:
City:
Jinan
Zip:
250117
Country:
China
Contact:
Last name:
Pingping Song
Start date:
March 2023
Completion date:
July 2025
Lead sponsor:
Agency:
Pingping Song
Agency class:
Other
Source:
Shandong Cancer Hospital and Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05765877
