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

A Real World Study to Evaluate the Efficacy and Safety of First Line Crizotinib in ALK Rearranged Advanced Non Squamous Non-small Cell Lung Cancer

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03647111

Enrollment

120

Registered

2018-08-27

Start date

2018-01-01

Completion date

2025-12-01

Last updated

2023-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small Cell Lung Cancer, ALK rearranged, Crizotinib

Brief summary

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.

Detailed 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.

Interventions

DRUGCrizotinib

Crizotinib 250mg po bid

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
PFS	Approximately 1 years	Progression free survival

Secondary

Measure	Time frame	Description
OS	Approximately 1 years	Overall survival

Countries

China

Contacts

Primary ContactYongchang Zhang, MD

zhangyongchang@csu.edu.cn+8613873123436

Backup ContactNong Yang, MD

yangnong0217@163.com+8613873123436

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026