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

Study Overview
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Brief Summary
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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).

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

Conditions
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Non-Small Cell Lung Cancer(NSCLC)

Intervention / Treatment
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* Drug: WX-0593 Tablets


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WX-0593<br>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. | Drug: WX-0593 Tablets<br>* 60 mg of WX-0593 tablets, once daily for 7 days, followed by 180 mg of WX-0593 tablets, once daily in a 28-days cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Pathologic Response (MPR) Rate | Major pathologic response (MPR) rate is defined as percentage of residual viable tumor cells histologically detected in the resected primary tumor after surgery ≤10%. | At time of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic Complete Response (pCR) Rate | Pathologic complete response (pCR) rate is defined as the percentage of participants with absence of residual tumor in lung and lymph nodes. | At time of surgery | 
| Resectability rate | Resectability rate is defined as the percentage of participants who were able to undergo surgery after neoadjuvant therapy. | At time of surgery | 
| R0 Resection rate | R0 Resection rate is defined as the percentage of participants who were able to undergo R0 Resection surgery after neoadjuvant therapy. | At time of surgery | 
| Objective Response Rate (ORR) | Objective Response Rate (ORR) is defined as the percentage of participants who have a complete response (CR) or partial response (PR). Responses are according to RECIST 1.1 as assessed by investigator. | Prior to surgery | 
| Disease Control Rate (DCR) | Disease Control Rate (DCR) is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD). Responses are according to RECIST 1.1 as assessed by investigator. | Prior to surgery | 
| Event-free survival (EFS) | Event-free survival (EFS) is the length of time after initial administration the participant remains free of recurrence/progression or death, whatever the cause. | 3 years postoperatively | 
| Disease-free survival (DFS) | Disease-free survival (DFS) is the length of time after surgical resection the participant remains free of recurrence/progression or death, whatever the cause. | 3 years postoperatively | 
| Overall Survival (OS) | Overall Survival (OS) is the length of time after initial administration the participant remains alive. | 3 years postoperatively |