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

Non-Small Cell Lung Cancer(NSCLC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05765877
• Other study ID #: WX0593-IIT-001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 2023
• Est. completion date: July 2025

Study information

• Verified date: March 2023
• Source: Shandong Cancer Hospital and Institute
• Contact: Pingping Song
• Phone: 18663776711
• Email: SPP128[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: July 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer(NSCLC)

Intervention

Drug:
• WX-0593 Tablets
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.

Locations

Country	Name	City	State
China	Shandong Cancer Hospital and Institute	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Pingping Song

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Resectability rate	Resectability rate is defined as the percentage of participants who were able to undergo surgery after neoadjuvant therapy.	At time of surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Overall Survival (OS)	Overall Survival (OS) is the length of time after initial administration the participant remains alive.	3 years postoperatively