Stage III NSCLC RWE in Chinese Patients

February 14, 2025 updated by: AstraZeneca

Real-World Molecular Testing, Treatment Patterns and Clinical Outcomes in Chinese Patients With Stage III NSCLC- A Prospective, Non-Interventional Study(MOOREA)

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Bei Jing, China, 100020
        • Research Site
      • Bei Jing, China, 100044
        • Research Site
      • Bei Jing, China
        • Research Site
      • Chang Chun, China, 130021
        • Research Site
      • Chengdu, China, 610041
        • Research Site
      • Chengdu, China, 610042
        • Research Site
      • Da Tong, China, 030000
        • Research Site
      • Da Tong, China
        • Research Site
      • Fen Yang, China
        • Research Site
      • Guang Zhou, China
        • Research Site
      • He Fei, China, 330006
        • Research Site
      • Hong Kong, China
        • Research Site
      • Ji Nan, China, 2501117
        • Research Site
      • Nan Ning, China, 530021
        • Research Site
      • Qing Dao, China
        • Research Site
      • Shan Tou, China
        • Research Site
      • Shanghai, China
        • Research Site
      • Shanghai, China, 200030
        • Research Site
      • Shanghai, China, 200040
        • Research Site
      • Shijiazhuang, China, 050011
        • Research Site
      • Shijiazhuang, China, 063000
        • Research Site
      • Shijiazhuang, China, 430079
        • Research Site
      • Tai Zhou, China
        • Research Site
      • Tian Jin, China
        • Research Site
      • Yin Chuan, China, 750004
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
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.
Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
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
Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
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.
Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2019

Primary Completion (Actual)

February 29, 2024

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

May 30, 2019

First Submitted That Met QC Criteria

July 17, 2019

First Posted (Actual)

July 18, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4194R00009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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