Stage III NSCLC RWE in Chinese Patients

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 29, 2024

Arms, Groups and 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 130 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor

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