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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03647111
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Yongchang Zhang, Hunan Province Tumor Hospital

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
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.

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Study Type : Observational
Estimated 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 : January 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Crizotinib

Group/Cohort Intervention/treatment
Cohorts 1 Drug: Crizotinib
Crizotinib 250mg po bid




Primary Outcome Measures :
  1. PFS [ Time Frame: Approximately 1 years ]
    Progression free survival


Secondary Outcome Measures :
  1. OS [ Time Frame: Approximately 1 years ]
    Overall survival


Biospecimen Retention:   Samples With DNA
tissue sample and plasma DNA


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
the patients who diagnosed ALK positive mutation in advanced non squamous non small cell lung cancer treated by Crizotinib.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647111


Contacts
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Contact: Yongchang Zhang, MD +8613873123436 ext +8613873123436 zhangyongchang@csu.edu.cn
Contact: Nong Yang, MD +8613873123436 ext +8613873123436 yangnong0217@163.com

Locations
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China, Hunan
Hunan Cancer Hospital Recruiting
Changsha, Hunan, China, 410013
Contact: Yongchang Zhang, MD    +86 731 89762323    zhangyongchang@csu.edu.cn   
Contact: Nong Yang, MD    +86 731 89762321    yangnong0217@163.com   
Sponsors and Collaborators
Hunan Province Tumor Hospital
Investigators
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Principal Investigator: Yongchang Zhang, MD Hunan Cancer Hospital
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Responsible Party: Yongchang Zhang, Professor, Hunan Province Tumor Hospital
ClinicalTrials.gov Identifier: NCT03647111    
Other Study ID Numbers: RECURE
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yongchang Zhang, Hunan Province Tumor Hospital:
Non-small Cell Lung Cancer
ALK rearranged
Crizotinib
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Crizotinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action