Stage III NSCLC RWE in Chinese Patients

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04023812
• Other study ID #: D4194R00009
• Status: Completed
• Start date: July 16, 2019
• Est. completion date: February 29, 2024

Study information

• Verified date: March 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Locations

Country	Name	City	State
China	Research Site	Bei Jing
China	Research Site	Bei Jing
China	Research Site	Bei Jing
China	Research Site	Chang Chun
China	Research Site	Chengdu
China	Research Site	Chengdu
China	Research Site	Da Tong
China	Research Site	Da Tong
China	Research Site	Fen Yang
China	Research Site	Guang Zhou
China	Research Site	He Fei
China	Research Site	Hong Kong
China	Research Site	Ji Nan
China	Research Site	Nan Ning
China	Research Site	Qing Dao
China	Research Site	Shan Tou
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shijiazhuang
China	Research Site	Shijiazhuang
China	Research Site	Shijiazhuang
China	Research Site	Tai Zhou
China	Research Site	Tian Jin
China	Research Site	Yin Chuan

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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