Back to resultsNeoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer
Primary Purpose
Non-Small Cell Lung Cancer(NSCLC)
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
WX-0593 Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer(NSCLC)
Eligibility Criteria
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.
Sites / Locations
- Shandong Cancer Hospital and Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
WX-0593
Arm 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.
Outcomes
Primary Outcome Measures
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%.
Secondary Outcome Measures
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.
Resectability rate
Resectability rate is defined as the percentage of participants who were able to undergo surgery after neoadjuvant therapy.
R0 Resection rate
R0 Resection rate is defined as the percentage of participants who were able to undergo R0 Resection surgery after neoadjuvant therapy.
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.
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.
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.
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.
Overall Survival (OS)
Overall Survival (OS) is the length of time after initial administration the participant remains alive.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05765877
Brief Title
Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer
Official Title
Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer : a Single-arm, Exploratory Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pingping Song
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer(NSCLC)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
WX-0593
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
WX-0593 Tablets
Intervention Description
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.
Primary Outcome Measure Information:
Title
Major Pathologic Response (MPR) Rate
Description
Major pathologic response (MPR) rate is defined as percentage of residual viable tumor cells histologically detected in the resected primary tumor after surgery ≤10%.
Time Frame
At time of surgery
Secondary Outcome Measure Information:
Title
Pathologic Complete Response (pCR) Rate
Description
Pathologic complete response (pCR) rate is defined as the percentage of participants with absence of residual tumor in lung and lymph nodes.
Time Frame
At time of surgery
Title
Resectability rate
Description
Resectability rate is defined as the percentage of participants who were able to undergo surgery after neoadjuvant therapy.
Time Frame
At time of surgery
Title
R0 Resection rate
Description
R0 Resection rate is defined as the percentage of participants who were able to undergo R0 Resection surgery after neoadjuvant therapy.
Time Frame
At time of surgery
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
Prior to surgery
Title
Disease Control Rate (DCR)
Description
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.
Time Frame
Prior to surgery
Title
Event-free survival (EFS)
Description
Event-free survival (EFS) is the length of time after initial administration the participant remains free of recurrence/progression or death, whatever the cause.
Time Frame
3 years postoperatively
Title
Disease-free survival (DFS)
Description
Disease-free survival (DFS) is the length of time after surgical resection the participant remains free of recurrence/progression or death, whatever the cause.
Time Frame
3 years postoperatively
Title
Overall Survival (OS)
Description
Overall Survival (OS) is the length of time after initial administration the participant remains alive.
Time Frame
3 years postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pingping Song
Phone
18663776711
Email
SPP128@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Guodong Zhang
Phone
15701206264
Email
zzkzgd@163.com
Facility Information:
Facility Name
Shandong Cancer Hospital and Institute
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pingping Song
12. IPD Sharing Statement
Learn more about this trial
Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer
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