Menu
Recruiting NCT05765877

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

Phase II Interventional Non-Small Cell Lung Cancer(NSCLC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: WX-0593 Tablets.
Who it may be relevant to
Registry conditions: Non-Small Cell Lung Cancer(NSCLC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer : a Single-arm, Exploratory Trial

Overview

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).

Interventions

  • Drug WX-0593 Tablets
    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.

Primary outcome measures

  • Major Pathologic Response (MPR) Rate [Time frame: At time of surgery]
Secondary outcome measures (8)
  • Pathologic Complete Response (pCR) Rate [Time frame: At time of surgery]
  • Resectability rate [Time frame: At time of surgery]
  • R0 Resection rate [Time frame: At time of surgery]
  • Objective Response Rate (ORR) [Time frame: Prior to surgery]
  • Disease Control Rate (DCR) [Time frame: Prior to surgery]
  • Event-free survival (EFS) [Time frame: 3 years postoperatively]
  • Disease-free survival (DFS) [Time frame: 3 years postoperatively]
  • Overall Survival (OS) [Time frame: 3 years postoperatively]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shandong Cancer Hospital and Institute — Jinan

Identifiers

NCT: NCT05765877 · WX0593-IIT-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗