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

NCT05765877 | Recruiting Phase 2

• 1 other identifier: WX0593-IIT-001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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).

Conditions

Non-Small Cell Lung Cancer(NSCLC)

Outcome Measures

Primary Outcomes (1)

• Major Pathologic Response (MPR) Rate

  Major pathologic response (MPR) rate is defined as percentage of residual viable tumor cells histologically detected in the resected primary tumor after surgery ≤10%.

  At time of surgery

Secondary Outcomes (8)

• Pathologic Complete Response (pCR) Rate

  At time of surgery

• Resectability rate

  At time of surgery

• R0 Resection rate

  At time of surgery

• Objective Response Rate (ORR)

  Prior to surgery

• Disease Control Rate (DCR)

  Prior to surgery

Study Arms (1)

WX-0593

EXPERIMENTAL

The treatment will be administrated as neoadjuvant 8 weeks before surgery. After surgical intervention the treatment will be administered up to 2 years. Treatment will be discontinued in case of unacceptable toxicity or disease progression.

Drug: WX-0593 Tablets

Interventions

WX-0593 Tablets DRUG

60 mg of WX-0593 tablets, once daily for 7 days, followed by 180 mg of WX-0593 tablets, once daily in a 28-days cycle.

WX-0593

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Pingping Song: lead

Study Sites (1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, 250117, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Pingping Song

CONTACT

18663776711; SPP128@126.com

Guodong Zhang

CONTACT

15701206264; zzkzgd@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department director

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

CN (1)