Neoadjuvant treatment for ALK-positive or ROS1-positive lung cancer
Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer : a Single-arm, Exploratory Trial
This study is testing a new pill called WX-0593 to see if it can shrink tumors in patients with a specific type of lung cancer before they have surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shandong Cancer Hospital and Institute Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT05765877 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of WX-0593, a novel treatment, in patients with resectable non-small cell lung cancer (NSCLC) that is either ALK-positive or ROS1-positive. It is a single-arm, exploratory Phase 2 trial where participants will receive WX-0593 tablets before surgical resection of their tumors. The study aims to determine how well this treatment works in shrinking tumors and improving surgical outcomes. Patients will be closely monitored for safety and effectiveness throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed ALK-positive or ROS1-positive NSCLC in Stage IB-IIIA who are eligible for complete surgical resection.
Not a fit: Patients who have previously received systemic anti-cancer therapies or have mixed small cell and NSCLC histology may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve surgical outcomes and overall survival for patients with specific types of lung cancer.
How similar studies have performed: While this approach is exploratory, similar studies targeting specific genetic mutations in lung cancer have shown promising results in improving treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jinan, Shandong
- Shandong Cancer Hospital and Institute — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Pingping Song
- Email: SPP128@126.com
- Phone: 18663776711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.