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Real World Study on First Line Crizotinib in ROS1 Rearranged Advanced Non-squamous Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT03646994
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Yongchang Zhang, Hunan Province Tumor Hospital

Brief Summary:
This study was designed to explore the efficacy and safety of Crizotinib as a first-line treatment for advanced NSCLC with ROS1 rearrangement positive mutation in the real world, explore the new drug resistance mechanism of ROS1 under Crizotinib treatment and the consistency of plasma and tissue detection driving genes, and finally evaluate the mutation spectrum of plasma dynamic detection driving genes. In predicting the risk of disease progression.

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Drug: Crizotinib

Detailed Description:
This is a research project involving patients in Medical Oncology Department of Affiliated Cancer Hospital of Xiangya School of Medicine Central South University. Retrospective study of 40 patients with advanced non-squamous non-small cell lung cancer (NSCLC) using Crizotinib ROS1 rearrangement positive mutation was conducted to observe the efficacy and safety of Crizotinib regimen in the real world.Exploratory research contents are as follows: 1. Consistency between tissue gene test (NGS) and plasma gene test (NGS) at the initial diagnosis; 2. Consistency between NGS and plasma gene test (NGS) at the progression of clozotinib treatment; 3. Drug resistance mechanism of clozotinib in ROS1 rearrangement positive NSCLC; 4. Plasma drug resistance. Large panel dynamic driven gene mutation analysis was used to construct disease progression risk model.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Real World Study to Evaluate the Efficacy and Safety of First Line Crizotinib in ROS1-rearranged Non-squamous Non-small Cell Lung Cancer
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Crizotinib

Group/Cohort Intervention/treatment
Cohorts 1
ROS1 fusion positive NSCLC patients who received crizotinib
Drug: Crizotinib
Crizotinib Cap 250 mg po bid




Primary Outcome Measures :
  1. PFS [ Time Frame: may 2018- may 2019 (1 year) ]
    progression survival time


Secondary Outcome Measures :
  1. ORR [ Time Frame: may 2018- may 2019 (1 year) ]
    objective response rate

  2. OS [ Time Frame: may 2018- may 2019 (1 year) ]
    over survival time


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:   Yes
Sampling Method:   Probability Sample
Study Population
ROS1 rearranged Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by NGS
Criteria

Inclusion Criteria:

  • ≥18,Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology
  • ROS1 Arranged Positive
  • ROS1 Arranged Detection Method is NGS
  • First Diagnosis and Treatment
  • Treatment Plan is Kazolinib 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): NCT03646994


Contacts
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Contact: Yongchang Zhang, MD +8613873123436 ext 7+861383123436 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: NCT03646994    
Other Study ID Numbers: CORE
First Posted: August 24, 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
Crizotinib
ROS1 Rearranged
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