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NCT05765877RecruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 12 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
26 (estimated)
First submitted
1 Mar 2023
Start date
1 Mar 2023
Primary completion date
31 Mar 2027
Lead sponsor
Pingping Song
Diseases
Lung cancer
NCT number
NCT05765877

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 26
  • From 1 Mar 2023 to the primary completion date, 31 Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other

  • Mixed small cell and NSCLC histology.
  • Patients who are candidates to undergo only segmentectomies or wedge resections.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shandong Cancer Hospital and Institute
Coordinator of this site? Confirm its status
JinanChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.