Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer : a Single-arm, Exploratory Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Shandong Cancer Hospital and Institute
RECRUITING
Jinan
Contact Information
Primary
Pingping Song
SPP128@126.com
18663776711
Backup
Guodong Zhang
zzkzgd@163.com
15701206264
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2029-03
Participants
Target number of participants: 26
Treatments
Experimental: WX-0593
The treatment will be administrated as neoadjuvant 8 weeks before surgery. After surgical intervention the treatment will be administered up to 2 years. Treatment will be discontinued in case of unacceptable toxicity or disease progression.
Related Therapeutic Areas
Sponsors
Leads: Pingping Song