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Идёт набор NCT06491862

RACE-2L: Real-World Assessment of Clinical Practice and Outcomes in Non-squamous NSCLC After Failure of Platinum-based Chemotherapy in Brazil

— Наблюдательное Non-squamous Non-Small Cell Lung Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Non-squamous Non-Small Cell Lung Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бразилия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

RACE-2L: Real-World Assessment of Clinical Practice and Outcomes in Non-squamous Non-Small Cell Lung Cancer After Failure of Platinum-based Chemotherapy in Brazil

Обзор

The study will be implemented as a retrospective, noninterventional medical record review of patients from routine practice settings who have been diagnosed with a/m non-squamous NSCLC with or without AGA and received at least 1 line of systemic treatment after failing PTC between January 2017 and December 2024.

Подробное описание

The study will be implemented as a retrospective, noninterventional medical record review of patients from routine practice settings who have been diagnosed with advanced/metastaic non-squamous NSCLC with or without AGA and who have failed platinum-based chemotherapy and immunotherapy (for patients without AGA) or platinum-based chemotherapy and at least 1 line of targeted therapy (for patients with AGA). The study will be conducted on one cohort of patients regardless their AGA status. The study index date will be defined as first dose of any agent after PTC, with specific treatments received for AGA and non-AGA patients in the preindex period. We will also conduct a subgroup analysis on NSCLC pre-defined subtypes (sample size permitting): EGFR mutant, ALK translocation, ROS1 translocation, MET1 mutant, HER-2 mutant, BRAF mutant, pan-wild-type PD-L1 \>50%.

Первичные конечные точки

  • Describe the patient population and treatment patterns [Срок оценки: between January 1st 2017 and December 31th 2024]
  • Describe the patient population and treatment patterns [Срок оценки: between January 1st 2017 and December 21th 2024]
  • Describe the patient population and treatment patterns [Срок оценки: between January 1st 2017 and December 21th 2024]
  • Describe the patient population and treatment patterns [Срок оценки: between January 1st 2017 and December 31th 2024]
  • Describe the patient population and treatment patterns [Срок оценки: between January 1st 2017 and December 31th 2024]
  • Describe the patient population and treatment patterns [Срок оценки: between January 1st 2017 and December 31th 2024]
  • Describe the patient population and treatment patterns [Срок оценки: between January 1st 2017 and December 31th 2024]
  • Describe the patient population and treatment patterns [Срок оценки: between January 1st 2017 and December 31th 2024]
  • Describe the patient population and treatment patterns [Срок оценки: between January 1st 2017 and December 31th 2024]
  • Describe the patient population and treatment patterns [Срок оценки: between January 1st 2017 and December 31th 2024]

Критерии участия

Критерии включения

  • Confirmed diagnosis of patients with non-squamous NSCLC stage IIIB/IIIC not eligible for curative-intent therapies or stage IV/M1 (a/m NSCLC) with or without actionable genomic mutations (i.e., EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, RET, HER-2)
  • Aged at least 18 years at first diagnosis of a/m NSCLC
  • For the AGA subgroup, having received platinum-based chemotherapy, having received at least one target approved therapy.
  • For the non\_AGA subgroup,should have received either sequential or concurrent use of ICI and PTC)
  • Patient must have received at least line of therapy of an active agent after failing PTC.

Критерии исключения

  • Patients with evidence of other primary malignancies (apart from basal cell carcinoma and melanoma) within 1 year prior to the index date will be excluded from both the study cohorts.
  • Patients who participated in an investigational clinical trial for the treatment of any cancer, including NSCLC, or any early access program from 2018 onward.

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 · 11 центров
  • Research Site — Belo Horizonte
  • Research Site — Belo Horizonte
  • Research Site — Natal
  • Research Site — Porto Alegre
  • Research Site — São José do Rio Preto
  • Research Site — São Paulo
  • Research Site — São Paulo
  • Research Site — São Paulo
  • … и ещё 3 центра

Идентификаторы

NCT: NCT06491862 · D133HR00041

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗