First-line treatment choices and patient profiles in advanced non-small cell lung cancer
DeniLA: Comprehensive Demographics and Clinical Profile of NSCLC Patients: Analyzing Guideline-Concordant Care in First-line Treatment Patterns Observational Study (Prospective and Survey); Evaluation Patterns of Choice in First Line Treatment of Metastatic NSCLC
This project will collect electronic medical record data from adults with advanced non‑small cell lung cancer starting first‑line treatment to see if real‑world care and biomarker use (like driver mutations and PD‑L1) match guideline recommendations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 7 sites (Recife and 6 other locations) |
| Trial ID | NCT07109154 on ClinicalTrials.gov |
What this trial studies
This is a prospective, observational, multicenter cohort that will extract demographic and clinical data from electronic medical records for a convenience sample of about 200 patients across participating centers. Eligible patients are adults with advanced (unresectable or metastatic) non‑small cell lung cancer who begin first‑line systemic treatment between January 2025 and January 2026. Patients with localized disease amenable to local therapy, non‑epithelial histologies, small cell carcinoma, neuroendocrine tumors, or prior PACIFIC‑protocol treatment are excluded. The project also includes a physician survey to capture the factors that influence first‑line regimen selection.
Who should consider this trial
Good fit: Adults over 18 with unresectable or metastatic non‑small cell lung cancer who start first‑line oncologic treatment at one of the participating centers between January 2025 and January 2026 and have data in electronic medical records.
Not a fit: Patients with localized disease suitable for local treatment, non‑epithelial histologies, small cell carcinoma, neuroendocrine tumors, those treated outside participating centers, or without electronic records are not eligible and will not benefit from inclusion.
Why it matters
Potential benefit: If successful, the study could reveal gaps in guideline‑concordant first‑line care and biomarker testing that inform improvements in treatment access and decision making.
How similar studies have performed: Similar real‑world analyses of NSCLC treatment patterns and biomarker use have been done and have repeatedly identified regional gaps in guideline adherence and testing, so the approach is established though findings vary by setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Advanced (unresectable or metastatic) non-small cell lung carcinoma * First-line oncological treatment in one of the participating centers between 2025 and 2026 (between January 2025 and January 2026) * \> 18 years old * Data available in electronic medical records. Exclusion Criteria: * Localized disease amenable to local treatment * Non-epithelial histology * Small cell carcinoma * Neuroendocrine tumor * Patients with unresectable NSCLC who underwent treatment with the PACIFIC protocol and are being followed up.
Where this trial is running
Recife and 6 other locations
- Research Site — Recife, Brazil (Active_not_recruiting)
- Research Site — Rio de Janeiro, Brazil (Recruiting)
- Research Site — Rio de Janeiro, Brazil (Not_yet_recruiting)
- Research Site — Salvador, Brazil (Recruiting)
- Research Site — Salvador, Brazil (Not_yet_recruiting)
- Research Site — São Paulo, Brazil (Active_not_recruiting)
- Research Site — São Paulo, Brazil (Not_yet_recruiting)
Study contacts
- Principal investigator: Clarissa Baldotto — Instituto D'Or de Pesquisa e Ensino
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.