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

Summary

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.

Conditions3

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