Small/Middle Tier Cities and County Lung Cancer Quality Improvement Project (QIP) Study

Recruiting

• Conditions: Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Respiratory Tract Diseases; Lung Neoplasms; Neoplasms; Carcinoma, Bronchogenic; Lung Diseases; Thoracic Neoplasms; Neoplasms by Site; Bronchial Neoplasms

• Registration Number: NCT06494241
• Lead Sponsor: AstraZeneca

Brief Summary

To evaluate the molecular testing pattern in metastatic NSCLC patients after QIP; To evaluate the treatment pattern in metastatic NSCLC patients after QIP.

Detailed Description

The primary objective of this study is to assess the implementation of standardized diagnosis and treatment practice in oncology departments of Small/Middle tier cities and County hospitals, after standardized education and implementation of lung cancer clinical practice guidelines for oncology physicians.

Study Timeline

• Study First Submitted: 2024-07-02
• Study First Submitted QC: 2024-07-02
• Study First Posted: 2024-07-10
• Study Start: 2024-11-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-27
• Primary Completion: 2027-11-28
• Study Completion: 2027-11-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Age ≥18 years, at the time of signing the informed consent.
• ECOG performance status 0-2.
• Newly pathologic diagnosed metastatic NSCLC (clinical stage IV) or recurrent metastatic NSCLC.

Exclusion Criteria

• Be participating in other intervention clinical trials.
• Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
• Previous enrolment in the other QIP study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the molecular testing pattern in metastatic NSCLC patients after QIP	Follow up approximately 24 months after last patient in	Molecular testing-rate for the first-line treatment: Defined as the number of participants received molecular testing for the first-line treatment divided by total participants.
To evaluate the treatment pattern in metastatic NSCLC patients after QIP	Follow up approximately 24 months after last patient in	TKIs first-line treatment rate: Defined as TKIs first-line treatment rate in AGA positive participants.

Secondary Outcome Measures

Name	Time	Method
To evaluate the clinical outcomes in metastatic NSCLC patients after QIP	Follow up approximately 24 months after last patient in	Duration of Response: Defined as the time from first-line treatment response to disease progression or death in participants who achieve responding by investigator assessment as recorded in CRF.
To evaluate the treatment pattern in metastatic NSCLC patients after QIP	Follow up approximately 24 months after last patient in	Immunotherapy first-line treatment rate: Defined as PD-1 or PD-L1 inhibitors first-line treatment rate in AGA negative participants.

Trial Locations

Locations (1)

Research Site; 🇨🇳 Zhuji, China