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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 16, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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