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RECRUITINGPhase 2NCT05765877

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

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).

Lead sponsor: Pingping Song•1 locations•View source on ClinicalTrials.gov

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Contacts

Pingping Song

CONTACT

18663776711 SPP128@126.com

Guodong Zhang

CONTACT

15701206264 zzkzgd@163.com

Sponsors

Lead Sponsor

Pingping Song

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: June 12, 2025Terms

Trial snapshot

StatusRECRUITING

PhasePHASE2

Enrollment26

Start dateMar 2023

Last updatedJun 12, 2025

Condition

Non-Small Cell Lung Cancer(NSCLC)

Locations shown

Shandong Cancer Hospital and Institute

Jinan, Shandong

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 12, 2025Data synced to Clareo: April 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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