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Real World Study on First Line Crizotinib in ROS1 Rearranged Advanced 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. Identifier: NCT03646994
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Information provided by (Responsible Party):
Yongchang Zhang, MD, 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
Effectiveness and Safety for Real World Study on Crizotinib Used for ROS1 Arranged Non-squamous 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, 2018
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Crizotinib

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

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

Secondary Outcome Measures :
  1. ORR [ Time Frame: may 2018- may 2019 (1 year) ]
  2. OS [ Time Frame: may 2018- may 2019 (1 year) ]

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

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 identifier (NCT number): NCT03646994

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Contact: Yongchang Z MD, MD +8613873123436 ext 7+861383123436
Contact: Yongchang Z MD, PhD +8613873123436 ext +8613873123436

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China, Hunan
Hunan Provincal Tumor Hospital Recruiting
Changsha, Hunan, China, 410013
Contact: Nong Yang, MD    +86 731 89762323   
Contact: Chunhua Zhou, MD    +86 731 89762321   
Principal Investigator: Nong Yang, MD         
Sponsors and Collaborators
Hunan Province Tumor Hospital

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Responsible Party: Yongchang Zhang, MD, Professor, Hunan Province Tumor Hospital Identifier: NCT03646994     History of Changes
Other Study ID Numbers: CORE
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

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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, MD, Hunan Province Tumor Hospital:
Non-small Cell Lung Cancer
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
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action