NCT05132218

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 180 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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;

Detailed 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:

Conditions

• ALK Positive
• NSCLC Stage IIIB
• NSCLC Stage IV

Interventions

Type	Name	Description
DRUG	Ensatinib	Prospective, exploratory, single-arm, multi-center, real-world research

Timeline

• Start date: 2021-10-19
• Primary completion: 2022-10-30
• Completion: 2024-10-30
• First posted: 2021-11-24
• Last updated: 2021-11-24

Locations

1 site across 1 country: China