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

Phase 2RecruitingNCT05765877

Pingping Song26 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Small Cell Lung Cancer(NSCLC)

Interventions

WX-0593 TabletsDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

RECRUITING

Outcomes

Primary Outcomes

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%.

Time frame: At time of surgery

Secondary Outcomes

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.

Time frame: At time of surgery

Resectability rate

Resectability rate is defined as the percentage of participants who were able to undergo surgery after neoadjuvant therapy.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Prior to surgery

Event-free survival (EFS)

Central Contacts

Pingping Song

CONTACT

18663776711 SPP128@126.com

Guodong Zhang

CONTACT

15701206264 zzkzgd@163.com

Data from ClinicalTrials.gov

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