Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer
ConditionNon-Small Cell Lung Cancer(NSCLC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPingping Song
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- WX-0593 Tablets
Treatment groups
26 Participants
are divided into 1 treatment groupSponsors and collaborators
Pingping Song
Lead sponsor
Shandong Cancer Hospital and Institute
Sponsor institution
Source ClinicalTrials.gov