A Retrospective and Prospective, Observational, Real World Multi-cohort Study of Patients With Non-small Cell Lung Cancer (NSCLC) Initiating Approved Drugs Developed by AZ or as Part of an AZ Alliance
- Registration Number
- NCT06726720
- Lead Sponsor
- AstraZeneca
- Brief Summary
This is an ambispective, observational, multicenter and multicohort study, targeting patients with NSCLC initiating approved drugs developed by AZ or as part of an AZ alliance, in the participating countries, as monotherapy or in combination at any stage of disease. Three cohorts are designed, based on the stage of NSCLC (resectable, unresectable and metasta...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Adult patients (≥ 18 years old)
- Patients with histologically or cytologically proven NSCLC
- Patients initiated with approved drugs developed by AZ or as part of an AZ alliance at the time of the enrollment or within the previous three weeks.
- Informed patients who consent to participate in the study as per local regulations.
-
Patients participating in an interventional clinical trial for NSCLC*
* with the exception on low-interventional studies (RIPH2) where the intervention does not involve the NSCLC treatment
-
Patients already enrolled in another module of the cohort in UMBREALUNG
-
Patients under safeguard of justice, curatorship or guardianship
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cohort A (resectable NSCLC) rw DFS 3 to 5 years real-world Disease-Free Survival (rwDFS) for adjuvant protocol assessment
Cohort B (unresectable NSCLC): rwTFST 1 to 3 years real-world time to first subsequent systemic therapy (rwTFST)
Cohort C (metastatic NSCLC) rw TFST 1 to 3 years real-world time to first subsequent systemic therapy (rwTFST)
- Secondary Outcome Measures
Name Time Method Additional criteria of effectiveness 8 years