NCT05765877 Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer
| NCT ID | NCT05765877 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Pingping Song |
| Condition | Non-Small Cell Lung Cancer(NSCLC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 26 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 26 participants in total. It began in 2023-03-01 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05765877 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Small Cell Lung Cancer(NSCLC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05765877 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05765877 currently recruiting?
Yes, NCT05765877 is actively recruiting participants. Contact the research team at SPP128@126.com for enrollment information.
Where is the NCT05765877 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT05765877 clinical trial?
NCT05765877 is sponsored by Pingping Song. The trial plans to enroll 26 participants.
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