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

Pingping Song

Status and phase: Not yet enrolling; Phase 2

Conditions: Non-Small Cell Lung Cancer(NSCLC)

Treatments: Drug: WX-0593 Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT05765877

WX0593-IIT-001

Details and patient eligibility

About

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).

Enrollment: 26 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

WX-0593

Experimental group

Description:

The treatment will be administrated as neoadjuvant 8 weeks before surgery. After surgical intervention the treatment will be administered up to 2 years. Treatment will be discontinued in case of unacceptable toxicity or disease progression.

Treatment:

Drug: WX-0593 Tablets