Stage III NSCLC RWE in Chinese Patients

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT04023812
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-30
• Study Start: 2019-07-16
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-18
• Primary Completion: 2024-02-29
• Study Completion: 2024-02-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To observe treatment patterns 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	Treatment received before disease progress including chemotherapy, targeted therapy, immunotherapy, anti-angiogenesis therapy and radiotherapy

Secondary Outcome Measures

Name	Time	Method
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	Assessment of radiation pneumonitis observed with radiotherapy among patients with unresectable, stage III NSCLC
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	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 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	Adjuvant treatment received post surgery including chemotherapy, targeted therapy and radiotherapy.
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	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.

Trial Locations

Locations (1)

Research Site; 🇨🇳 Yin Chuan, China