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NCT Number: NCT04023812

Stage III NSCLC RWE in Chinese Patients

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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2019
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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