Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer

Recruiting now · Phase 2

Conditions studied: Non-Small Cell Lung Cancer(NSCLC)

In brief

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).

Key facts

Study ID

NCT05765877

Run by

Pingping Song

People needed

26

Starts

2023-03-01

Expected to finish

2029-03-01

Last updated by the study team

2025-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Shandong Cancer Hospital and Institute — Jinan, Shandong, China (enrolling)

Full record on ClinicalTrials.gov

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