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

Sponsor

Pingping Song (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05765877

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Non-Small Cell Lung Cancer(NSCLC)	Drug: WX-0593 Tablets	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

26 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: WX-0593 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 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.

Arm

Intervention/Treatment

Experimental: WX-0593

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

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.

Outcome Measures

Primary Outcome Measures

Major Pathologic Response (MPR) Rate [At time of surgery]
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 [At time of surgery]
Pathologic complete response (pCR) rate is defined as the percentage of participants with absence of residual tumor in lung and lymph nodes.
Resectability rate [At time of surgery]
Resectability rate is defined as the percentage of participants who were able to undergo surgery after neoadjuvant therapy.
R0 Resection rate [At time of surgery]
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) [Prior to surgery]
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) [Prior to surgery]
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) [3 years postoperatively]
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) [3 years postoperatively]
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) [3 years postoperatively]
Overall Survival (OS) is the length of time after initial administration the participant remains alive.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shandong Cancer Hospital and Institute	Jinan	Shandong	China	250117

Sponsors and Collaborators

Pingping Song

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pingping Song, Department director, Shandong Cancer Hospital and Institute

ClinicalTrials.gov Identifier:

NCT05765877

Other Study ID Numbers:

WX0593-IIT-001

First Posted:

Mar 13, 2023

Last Update Posted:

Mar 13, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Mar 13, 2023