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Clinical Trials/NCT04023812
NCT04023812CompletedNot Applicable

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

AstraZeneca1 site in 1 country500 target enrollmentStarted: July 16, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
500
Locations
1
Primary Endpoint
To observe treatment patterns of unresectable, stage III NSCLC

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 130 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

  • To estimate parameters associated with radiation pneumonitis(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(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(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 the clinical outcome of 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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