Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05765877

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Non-small Cell Lung Cancer(NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shandong Cancer Hospital and Institute

Jinan, Shandong, 250117, China

Location status: Recruiting

Location contact

Pingping Song

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Major Pathologic Response (MPR) Rate

    Time frame: At time of surgery

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

Secondary outcomes

  1. Pathologic Complete Response (pCR) Rate

    Time frame: At time of surgery

    Pathologic complete response (pCR) rate is defined as the percentage of participants with absence of residual tumor in lung and lymph nodes.

  2. Resectability rate

    Time frame: At time of surgery

    Resectability rate is defined as the percentage of participants who were able to undergo surgery after neoadjuvant therapy.

  3. R0 Resection rate

    Time frame: At time of surgery

    R0 Resection rate is defined as the percentage of participants who were able to undergo R0 Resection surgery after neoadjuvant therapy.

  4. Objective Response Rate (ORR)

    Time frame: Prior to surgery

    Objective Response Rate (ORR) is defined as the percentage of participants who have a complete response (CR) or partial response (PR). Responses are according to RECIST 1.1 as assessed by investigator.

  5. Disease Control Rate (DCR)

    Time frame: Prior to surgery

    Disease Control Rate (DCR) is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD). Responses are according to RECIST 1.1 as assessed by investigator.

  6. Event-free survival (EFS)

    Time frame: 3 years postoperatively

    Event-free survival (EFS) is the length of time after initial administration the participant remains free of recurrence/progression or death, whatever the cause.

  7. Disease-free survival (DFS)

    Time frame: 3 years postoperatively

    Disease-free survival (DFS) is the length of time after surgical resection the participant remains free of recurrence/progression or death, whatever the cause.

  8. Overall Survival (OS)

    Time frame: 3 years postoperatively

    Overall Survival (OS) is the length of time after initial administration the participant remains alive.

Study contacts

Contact information is provided by the study sponsor or research team.

Guodong Zhang

CONTACT

[email protected]

15701206264

Pingping Song

CONTACT

[email protected]

18663776711

Sponsors and collaborators

Lead sponsor

Pingping Song

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2029
First posted
Mar 13, 2023
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.