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出境医 / 临床实验 / Stage III NSCLC RWE in Chinese Patients

Stage III NSCLC RWE in Chinese Patients

Study Description
Brief Summary:
The objectives of this study are to assess molecular testing, treatment patterns and associated clinical outcomes in Chinese patients with treatment-naïve stage III non-small cell lung cancer (NSCLC) in real world setting. This study is a prospective, non-interventional study. It is descriptive in nature and does not attempt to test any specific a priori hypotheses

Condition or disease
Carcinoma, Non-Small-Cell Lung

Study Design
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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real-World Molecular Testing, Treatment Patterns and Clinical Outcomes in Chinese Patients With Stage III NSCLC- A Prospective, Non-Interventional Study(MOOREA)
Actual Study Start Date : July 16, 2019
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : May 30, 2022
Arms and Interventions
Group/Cohort
Cohort 1
Cohort 1, including patients without surgical resection, will be defined as unresectable stage III NSCLC
Cohort 2
Cohort 2,including patients with surgical resection, will be defined as resectable stage III NSCLC
Outcome Measures
Primary Outcome Measures :
  1. To observe treatment patterns of unresectable, stage III NSCLC [ Time Frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months ]
    Treatment received before disease progress including chemotherapy, targeted therapy, immunotherapy, anti-angiogenesis therapy and radiotherapy


Secondary Outcome Measures :
  1. To observe the clinical outcome of unresectable, stage III NSCLC [ Time Frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months ]
    Overall survival measured from the date of treatment initiation in the study to the date of death due to any cause; Progression-free Survival (PFS) measured from the date of treatment initiation in the study, until physician-reported progression or death due to any cause, whichever occurs first.

  2. To observe molecular testing patterns of stage III NSCLC [ Time Frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months ]

    Molecular testing patterns including:

    Molecular testing rate defined as the number of patients who received molecular testing divided by total patient's number; Molecular testing details including sample type, test type; Molecular testing results.


  3. To estimate parameters associated with radiation pneumonitis [ Time Frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months ]
    Assessment of radiation pneumonitis observed with radiotherapy among patients with unresectable, stage III NSCLC

  4. To observe adjuvant treatment patterns of resectable, stage III NSCLC [ Time Frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months ]
    Adjuvant treatment received post surgery including chemotherapy, targeted therapy and radiotherapy.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stage III NSCLC patients who received no prior systemic therapy for NSCLC before study enrolment
Criteria

Inclusion Criteria:

  • Male or female aged 18 years or older.
  • Provision of informed consent prior to any study specific procedures.
  • Histologically or cytologically confirmed locally advanced, stage III NSCLC (according to version 8 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology; IASLC Staging Manual in Thoracic Oncology).

Exclusion Criteria:

  • Enrolment in studies that prohibit any participation in this observational study.

    • Patients may be concurrently enrolled in unblinded clinical trials, but not blinded clinical trials in which the treatment being administered is unknown.
  • Prior surgery, radiotherapy or systemic therapy for NSCLC, including chemotherapy, targeted therapy, anti-angiogenesis, etc.
Contacts and Locations

Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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China, Beijing
Research Site Not yet recruiting
Beijing, Beijing, China
Research Site Recruiting
Beijing, Beijing, China
Research Site Withdrawn
Shenzhen, Beijing, China
China, Guangdong
Research Site Recruiting
Guangzhou, Guangdong, China
Research Site Recruiting
Shantou, Guangdong, China
China, Guangxi
Research Site Recruiting
Nanning, Guangxi, China
China, Hebei
Research Site Recruiting
Baoding, Hebei, China
Research Site Recruiting
Shijiazhuang, Hebei, China
Research Site Not yet recruiting
Shijiazhuang, Hebei, China
China, Heilongjian
Research Site Not yet recruiting
Qiqihar, Heilongjian, China
China, Hongkong
Research Site Recruiting
Hongkong, Hongkong, China
China, Hubei
Research Site Recruiting
Wuhan, Hubei, China
China, Jiangsu
Research Site Recruiting
Suzhou, Jiangsu, China
China, Jiangxi
Research Site Recruiting
Nanchang, Jiangxi, China
China, Jilin
Research Site Recruiting
Changchun, Jilin, China
China, Liaoning
Research Site Not yet recruiting
Dalian, Liaoning, China
China, Ningxia
Research Site Recruiting
Yinchuan, Ningxia, China
China, Shandong
Research Site Recruiting
Jinan, Shandong, China
Research Site Recruiting
Qingdao, Shandong, China
China, Shanghai
Research Site Recruiting
Shanghai, Shanghai, China
Research Site Not yet recruiting
Shanghai, Shanghai, China
Research Site Withdrawn
Shanghai, Shanghai, China
China, Shanxi
Research Site Recruiting
Taiyuan, Shanxi, China
China, Sichuan
Research Site Recruiting
Chengdu, Sichuan, China
China, Tianjin
Research Site Not yet recruiting
Tianjin, Tianjin, China
China, Zhejiang
Research Site Recruiting
Taizhou, Zhejiang, China
Sponsors and Collaborators
AstraZeneca
Tracking Information
First Submitted Date May 30, 2019
First Posted Date July 18, 2019
Last Update Posted Date April 28, 2021
Actual Study Start Date July 16, 2019
Estimated Primary Completion Date May 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 17, 2019)
To observe treatment patterns of unresectable, stage III NSCLC [ Time Frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months ]
Treatment received before disease progress including chemotherapy, targeted therapy, immunotherapy, anti-angiogenesis therapy and radiotherapy
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 17, 2019)
  • To observe the clinical outcome of unresectable, stage III NSCLC [ Time Frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months ]
    Overall survival measured from the date of treatment initiation in the study to the date of death due to any cause; Progression-free Survival (PFS) measured from the date of treatment initiation in the study, until physician-reported progression or death due to any cause, whichever occurs first.
  • To observe molecular testing patterns of stage III NSCLC [ Time Frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months ]
    Molecular testing patterns including: Molecular testing rate defined as the number of patients who received molecular testing divided by total patient's number; Molecular testing details including sample type, test type; Molecular testing results.
  • To estimate parameters associated with radiation pneumonitis [ Time Frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months ]
    Assessment of radiation pneumonitis observed with radiotherapy among patients with unresectable, stage III NSCLC
  • To observe adjuvant treatment patterns of resectable, stage III NSCLC [ Time Frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months ]
    Adjuvant treatment received post surgery including chemotherapy, targeted therapy and radiotherapy.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Stage III NSCLC RWE in Chinese Patients
Official Title Real-World Molecular Testing, Treatment Patterns and Clinical Outcomes in Chinese Patients With Stage III NSCLC- A Prospective, Non-Interventional Study(MOOREA)
Brief Summary The objectives of this study are to assess molecular testing, treatment patterns and associated clinical outcomes in Chinese patients with treatment-naïve stage III non-small cell lung cancer (NSCLC) in real world setting. This study is a prospective, non-interventional study. It is descriptive in nature and does not attempt to test any specific a priori hypotheses
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Stage III NSCLC patients who received no prior systemic therapy for NSCLC before study enrolment
Condition Carcinoma, Non-Small-Cell Lung
Intervention Not Provided
Study Groups/Cohorts
  • Cohort 1
    Cohort 1, including patients without surgical resection, will be defined as unresectable stage III NSCLC
  • Cohort 2
    Cohort 2,including patients with surgical resection, will be defined as resectable stage III NSCLC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 17, 2019)
700
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 30, 2022
Estimated Primary Completion Date May 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male or female aged 18 years or older.
  • Provision of informed consent prior to any study specific procedures.
  • Histologically or cytologically confirmed locally advanced, stage III NSCLC (according to version 8 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology; IASLC Staging Manual in Thoracic Oncology).

Exclusion Criteria:

  • Enrolment in studies that prohibit any participation in this observational study.

    • Patients may be concurrently enrolled in unblinded clinical trials, but not blinded clinical trials in which the treatment being administered is unknown.
  • Prior surgery, radiotherapy or systemic therapy for NSCLC, including chemotherapy, targeted therapy, anti-angiogenesis, etc.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04023812
Other Study ID Numbers D4194R00009
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party AstraZeneca
Study Sponsor AstraZeneca
Collaborators Not Provided
Investigators Not Provided
PRS Account AstraZeneca
Verification Date April 2021

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