DeniLA: Comprehensive Demographics and Clinical Profile of NSCLC Patients: Analyzing Guideline-Concordant Care in First-line Treatment Patterns

Официальное название

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

Обзор

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.

Первичные конечные точки

• Describe epidemiological characteristics of patients diagnosed with NSCLC in Brazil real-world. [Срок оценки: Through study completation, an average of 2 years]
• Describe first-line NSCLC treatment patterns in Brazil real-world. [Срок оценки: Through study completation, an average of 2 years]
• Evaluate the concordance between the therapeutic choices and the BSCO guidelines. [Срок оценки: Through study completation, an average of 2 years]

Вторичные конечные точки (4)

• Describe of the epidemiological characteristics and first-line therapeutic patterns according all locally approved treatment approaches in NSCLC patients. [Срок оценки: Through study completation,an average of 2 years]
• Evaluate the influence of the mutational profile and PD-L1 expression on the choice of treatment. [Срок оценки: Through study completation, an average of 2 years]
• 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. [Срок оценки: Through study completation, an average of 2 years]
• Evaluate differences between patterns of choice in first-line treatment between generalist medical oncologists through an online survey. [Срок оценки: Through study completation, an average of 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Бразилия · 7 центров

• Research Site — Recife
• Research Site — Rio de Janeiro
• Research Site — Rio de Janeiro
• Research Site — Salvador
• Research Site — Salvador
• Research Site — São Paulo
• Research Site — São Paulo

Идентификаторы

NCT: NCT07109154 · D133FR00224

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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