NCT06282536

Neoadjuvant Therapy With Iruplinalkib for Potentially Resectable ALK Positive NSCLC: A Single Arm, Exploratory Trial

Neoadjuvant Therapy With Iruplinalkib for Potentially Resectable ALK Positive Non-Small Cell Lung Cancer: A Single Arm, Exploratory Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Fusion of anaplastic lymphoma kinase (ALK) is an important driving gene for NSCLC, with an incidence rate of 3-7%. In patients with advanced ALK mutation NSCLC, first-line use of ALK inhibitors significantly improves progression free survival. The perioperative research on ALK positive NSCLC was relatively late, and currently most studies mainly focus on early to mid stage ALK positive NSCLC patients. The results of two Phase III clinical trials showed that second-generation ALK targeted drugs, neoadjuvant and/or adjuvant therapy for ALK positive NSCLC, significantly prolonged DFS in patients, including increased pathological response rate, median response duration, and prolonged OS. For ALK positive advanced NSCLC patients who are resistant to second-generation ALK targeted drugs, there is currently limited exploration and there is an urgent need for new exploratory clinical studies.This trial aims to evaluate the effectiveness of Iruplinalkib neoadjuvant therapy for potentially resectable ALK positive non-small cell lung cancer.

Conditions

• Potentially Resectable ALK Positive Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Iruplinalkib	60 mg on days 1-7, if tolerable, 180 mg from day 8 onwards.
PROCEDURE	surgery	Patients with resectable tumors after neoadjuvant therapy will be treated with surgery.

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-06-01
• Completion: 2029-12-01
• First posted: 2024-02-28
• Last updated: 2024-02-28