Neoadjuvant treatment for ALK-positive or ROS1-positive lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shandong Cancer Hospital and Institute
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Pingping Song
• Email: SPP128@126.com
• Phone: 18663776711

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.