Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer — EFLRWR  

NSCLC Stage IV Clinical Trial

Official title: Prospective Exploratory Real World Study of Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer

Status Recruiting

Clinical Trial Summary

The experimental design is exploratory, single-arm, multi-center, real-world research.

Ensatinib 225mg qd A prospective and exploratory real-world study of Ensatinib for ALK-positive advanced non-small cell lung cancer patients Test purposes Exploring the real world, Ensatinib is effective for the newly treated ALK+ advanced NSCLC

1. Efficacy and safety;

2. The relationship between molecular mechanism and curative effect;

3. Ensatinib resistance mechanism;

Clinical Trial Description

Enrolled patients:

1. stage IIIB or stage IV NSCLC

2. Each center confirmed ALK+ by tissue samples (Abbott FISH, VENTANA ALK D5F3, NGS method confirmation);

3. Without any ALK-TKI treatment; Study endpoint

Primary endpoint:

According to the RECIST1.1 standard, the progression-free survival (PFS) assessed by the investigator;

Secondary endpoint:

According to the RECIST1.1 standard, the objective response rate (ORR) evaluated by the investigator; the time to treatment failure (TTF); according to the RECIST1.1 standard, the ORR and PFS of patients with different ALK fusion subtypes evaluated by the investigator; total Lifetime (OS); safety;

Exploratory endpoint:

The correlation between the biomarkers in blood or/and tissue samples and the efficacy of Ensatinib; the resistance mechanism of Ensatinib;

The sample size is determined:

The plan is to analyze 60-80 patients with EML4-ALK fusion v1 and v3 subtypes. Based on the proportion of patients with both subtypes in ALK-positive patients, the proportion is about 40%. Based on the 20% dropout rate, the plan is to include ALK without distinction. 180 patients with fusion subtype; statistical methods: ;

Related Conditions & MeSH terms

• ALK Positive
• Carcinoma, Non-Small-Cell Lung
• NSCLC Stage IIIB
• NSCLC Stage IV

• NCT number: NCT05132218
• Study type: Observational
• Source: Beijing Cancer Hospital
• Contact: Jun Zhao, PhD
• Phone: 13521469335
• Email: ohjerry@163.com
• Status: Recruiting
• Start date: October 19, 2021
• Completion date: October 30, 2024