DeniLA: Comprehensive Demographics and Clinical Profile of NSCLC Patients: Analyzing Guideline-Concordant Care in First-line Treatment Patterns
- Conditions
- Lung Neoplasms
- Registration Number
- NCT07109154
- Lead Sponsor
- AstraZeneca
- Brief Summary
This is a prospective, observational, multicenter study, in which clinical and demographic data will be extracted from medical records. Convenience sample, with an estimated inclusion of 200 patients treated in seven participating centers.
Eligible tumors for this project will be from patients with advanced (unresectable or metastatic) non-small cell lung carcinoma, who will start first-line oncological treatment in one of the participating centers between 2025 and 2026 (between January 2025 and January 2026). Patients must be over 18 years old and data must be available in electronic medical records.
Medical records will be assessed to confirm patients' eligibility. Patients with localized disease amenable to local treatment, non-epithelial histology, small cell carcinoma and neuroendocrine tumor will not be eligible.
A survey will be designed targeting thoracic and generalist medical oncologists, aiming to understand the factors guiding the choice of first-line treatment regimens and to compare these insights with real-world data. The survey will be directed to Brazil, with an estimated of 200 filled files.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Describe epidemiological characteristics of patients diagnosed with NSCLC in Brazil real-world. Through study completation, an average of 2 years Clinical and demographic data will be extracted from medical records (gender, age at diagnosis, self-reported ethnicity, state, institutional profile (public or private), smoking status, lung cancer family history), clinical characteristics such as comorbidities, histology, extent of disease, metastasis location, tumor stage at diagnosis according AJCC eighth edition, ECOG status, frequency of biomarker and molecular testing (PDL-1 status, EGFR, ALK, ROS1, BRAF, NTRK, MET, HER2, KRAS, STK11, KEAP1). Descriptive statistics will be used to summarize the epidemiological characteristics.
Describe first-line NSCLC treatment patterns in Brazil real-world. Through study completation, an average of 2 years The therapeutic choice: platinum-based therapy, ICI in monotherapy or combined, targeted therapy regimen for patients with driver mutations, TKI inhibitors, bi-specifics, ALK inhibitors, etc, will be extracted from medical records. Descriptive statistics will be used to summarize the treatment patterns.
Evaluate the concordance between the therapeutic choices and the BSCO guidelines. Through study completation, an average of 2 years The concordance of real-life scenarios with the therapeutic guidelines of the Brazilian Society of Clinical Oncology (BSCO) will be assessed using Cohen's kappa coefficient.
- Secondary Outcome Measures
Name Time Method Describe of the epidemiological characteristics and first-line therapeutic patterns according all locally approved treatment approaches in NSCLC patients. Through study completation,an average of 2 years The therapeutic choice on each scenario (according to EGFR, ALK, ROS1, BRAF, NTRK, MET, HER2, KRAS, STK11, KEAP1 mutations and PDL-1 status) will be collected from medical records and described on this project using descriptive statistics.
Evaluate the influence of the mutational profile and PD-L1 expression on the choice of treatment. Through study completation, an average of 2 years Mutational profile and PD-L1 (presence of KRAS, KEAP1, STK11, SMARC4 co-mutations) will be collected from medical records. The influence of the mutational profile and PD-L1 expression on treatment choice will be assessed using descriptive statistics.
Evaluate the influence of clinical characteristics and mutational profile on the choice of first line treatment on EGFR mutated non-small cell lung cancer patients. Through study completation, an average of 2 years The influence of clinical characteristics and mutational profile on the choice of first-line treatment for EGFR-mutated NSCLC patients (collected from medical records) will be assessed using descriptive statistics.
Evaluate differences between patterns of choice in first-line treatment between generalist medical oncologists through an online survey. Through study completation, an average of 2 years Through a survey targeting thoracic and generalist medical oncologists with an estimated of 300 oncologists contacted. The differences in patterns of choice for first-line treatment among generalist medical oncologists will be summarized using descriptive statistics and compared using the Chi-squared test (or Fisher's exact test).
Trial Locations
- Locations (5)
Ensino e Terapia de Inovação Clinica AMO- ETICA
🇧🇷Salvador, Bahia, Brazil
Instituto D'oR de Pesquisa e Ensino
🇧🇷Recife, Pernambuco, Brazil
Oncoclínicas Rio de Janeiro S.A
🇧🇷Rio de Janeiro, Brazil
Fundação Antonio Prudente
🇧🇷São Paulo, Brazil
Instituto D'Or de Pesquisa e Ensino
🇧🇷São Paulo, Brazil
Ensino e Terapia de Inovação Clinica AMO- ETICA🇧🇷Salvador, Bahia, Brazil