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

• Sponsor: Hunan Province Tumor Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03647111
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Anticipated Duration (Months): 83
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Drug: Crizotinib

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: 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
• Actual Study Start Date: Jan 1, 2018
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Cohorts 1	Drug: Crizotinib; Crizotinib 250mg po bid

Outcome Measures

Primary Outcome Measures

1. PFS [Approximately 1 years]

   Progression free survival

Secondary Outcome Measures

1. OS [Approximately 1 years]

   Overall survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hunan Cancer Hospital	Changsha	Hunan	China	410013

Sponsors and Collaborators

• Hunan Province Tumor Hospital

Investigators

• Principal Investigator: Yongchang Zhang, MD, Hunan Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yongchang Zhang, Professor, Hunan Province Tumor Hospital
• ClinicalTrials.gov Identifier: NCT03647111
• Other Study ID Numbers: RECURE
• First Posted: Aug 27, 2018
• Last Update Posted: Mar 2, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yongchang Zhang, Professor, Hunan Province Tumor Hospital: Non-small Cell Lung Cancer; ALK rearranged; Crizotinib
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Crizotinib

Study Results

No Results Posted as of Mar 2, 2022