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).
Eligibility
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.