Stage III NSCLC RWE in Chinese Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Carcinoma, Non-Small-Cell Lung

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 130 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Cohort 1, including patients without surgical resection, will be defined as unresectable stage III NSCLC | |
| Cohort 2<br>Cohort 2,including patients with surgical resection, will be defined as resectable stage III NSCLC | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To observe treatment patterns of unresectable, stage III NSCLC | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prospective, observational, stage III NSCLC