Real World Study of First Line Crizotinib for ALK Rearranged Non-squamous Non-small Cell Lung Cancer

Hunan Province Tumor Hospital

Status: Enrolling

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Crizotinib

Study type: Observational

Funder types: Other

Identifiers

NCT03647111

RECURE

Details and patient eligibility

About

This study aims to explore the efficacy and safety of Crizotinib as a first-line therapy for advanced non-squamous non-small cell lung cancer with ALK-positive mutations in the real world.

Full description

According to the study of P11014 and P1029, Crizotinib is a first-line therapy for advanced non squamous non small cell lung cancer with positive ALK rearrangement.This study aims to explore the efficacy and safety of clozotinib as a first-line therapy for advanced non-squamous non-small cell lung cancer with ALK-positive mutations in the real world. Among them, ALK positive was based on NGS test results, exploring the new drug resistance mechanism of ALK under clozotinib treatment mode and consistency between plasma and tissue detection driving genes, and finally assessing the role of plasma dynamic detection driving gene mutation spectrum in predicting disease progression risk. A retrospective study of 120 patients with advanced NSCLC using clozotinib ALK positive mutation was conducted to observe the efficacy and safety of clozotinib regimen in the real world.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• ≥18，Pathologically proven ALK positive mutation in advanced non squamous non small cell lung cancer
• ALK rearrangement detection method is NGS and Ventana
• Primary treatment of first diagnosis
• The treatment was Crizotinib 250mg po bid Exclusion Criteria
• Patients received antitumor treatment before
• Patients with contraindication of chemotherapy
• Pregnant or breast feeding women

Trial design

120 participants in 1 patient group

Cohorts 1

Treatment:

Drug: Crizotinib