A Multi-Center Study to Evaluate the Guideline Education of Oncology Departments in Small/Middle Tier Cities and County Hospitals for Diagnosis and Treatment Improvement in Patients With Metastatic Non-small Cell Lung Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- AstraZeneca
- Enrollment
- 1,000
- Locations
- 47
- Primary Endpoint
- To evaluate the molecular testing pattern in metastatic NSCLC patients after QIP
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case-only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
To evaluate the molecular testing pattern in metastatic NSCLC patients after QIP
Time Frame: Approximately 1 month 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
Time Frame: Approximately 1 month after last patient in
TKIs first-line treatment rate: Defined as TKIs first-line treatment rate in AGA positive participants.
Secondary Outcomes
- To evaluate the clinical outcomes in metastatic NSCLC patients after QIP(Follow up approximately 24 months after last patient in)
- To evaluate the treatment pattern in metastatic NSCLC patients after QIP(Approximately 1 month after last patient in)
- To evaluate the clinical outcomes in metastatic NSCLC patients after QIP(Follow up approximately 24 months after last patient in)
Investigators
Study Sites (47)
Identifiers
- NCT ID
- NCT06494241
- Other Study IDs
- D5161L00048
Dates
- First Submitted
- (2 years ago)
- First Posted
- (2 years ago)
- Primary Completion
- (next year)
- Study Completion
- (next year)
- Last Verified
- (29 days ago)
- Last updated
- (yesterday)
Regulatory & Sharing
- FDA Regulated Drug
- No
- FDA Regulated Device
- No
- IPD Sharing Plan
- Yes
- Has Results
- No
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.