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Идёт набор NCT06726720

UmbREALung - 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

— Наблюдательное 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

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: 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. 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
Франция
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

A Prospective, Observational, Real World Multi-cohort Study of Patients With Non-small Cell Lung Cancer (NSCLC) Initiating AstraZeneca (or Alliance Developed) Drugs

Обзор

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 metastatic). The multicohort study is modular in design. Specific modules will be set up separately to assess each new indication of drugs developed by AZ or as part of an AZ alliance once European marketing authorization (MA) has been granted and made available in the participating countries. Patients will be enrolled in the study if they have received (retrospective), receive (retrospective and prospective) or will receive (prospective) approved drugs developed by AZ or as part of an AZ alliance according to the eligibility criteria. Treatment plan and decision are made independently by each treating physician prior to inclusion in this study.

Первичные конечные точки

  • Cohort A (resectable NSCLC)-Adjuvant rw DFS [Срок оценки: 3 years]
  • Cohort A (resectable NSCLC)- Peri-operative rw EFS [Срок оценки: 3 years]
  • Cohort B (unresectable NSCLC): median rwTFST [Срок оценки: 3 years]
  • Cohort C (metastatic NSCLC) rw TFST [Срок оценки: 3 years]
Вторичные конечные точки (12)
  • Response rates - all cohorts [Срок оценки: Response evaluation via patient's best response (PR, CR, SD, PD) and date of best response]
  • Additional rw EFS (cohort A - Peri-operative) [Срок оценки: rw EFS and rates at 6 months, 1y, 3y, 5y (rwEFS6m, rwEFS1y, rwEFS3y, rwEFS5y)]
  • Additional rwDFS (Cohort A- adjuvant) [Срок оценки: rwDFS and rates at 6 months, 1y, 3y, 5y (rwDFS6m, rwDFS1y, rwDFS3y, rwDFS5y)]
  • rwPFS (cohort B and C) [Срок оценки: Endpoints will be median real-world Progression Free Survival (rwPFS) and rates at 6, 12, 18, 24, 36 months and 5 years (rwPFS6m, rwPFS12m, rwPF18m, rwPFS24m, rwPFS36m, rwPFS5y)]
  • Early progressors-rates and characteristics of patients - all cohorts [Срок оценки: within 6 months]
  • rwPFS2 (all cohorts) [Срок оценки: rwPFS2 and rates at 6, 12, 18, 24, 36 months and 5 years (rwPFS2-6m, rwPFS2-12m, rwPFS2-18m, rwD-RFS24m, rwPFS2-3y, rwPFS2-5y)]
  • rwD-RFS or rwD-PFS ( cohort A and B) [Срок оценки: rwD-RFS and rates at 6, 12, 18, 24, 36 months and 5 years or rwD-PFS and rates at 6, 12, 18, 24, 36 months and 5 years]
  • Real-word locoregional recurrence-free survival (rwL-RFS) - cohort A and B [Срок оценки: rwL-RFS and rates at 6, 12, 18, 24, 36 months and 5 years (rwL-RFS6m, rwL-RFS12m, rwL-RFS18m, rwL-RFSm, rwL-RFS3y,rrwL-RFS5y)]
  • rwOS - all cohorts [Срок оценки: rwOS and rates at 6, 12, 18, 24, 36 months and 5 years (rwOS6m, rwOS12m, rwOS18m, rwOS24m, rwOS3y,rwOS5y)]
  • Real world time to treatment discontinuation (rwTTD) - all cohorts [Срок оценки: 3 or 5 years]
  • Real world time to next treatment (rwTTNT) - all cohorts [Срок оценки: rwTTNT and rates at 6 months, 1y, 3y,5y (rwTTNT6m, rwTTNT1y, rwTTNT3y,rwTTNTS5y)]
  • Real world time to first subsequent local treatment (rwTFST-local treatment) all cohorts [Срок оценки: 3 or 5 years]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 52 центра
  • Research Site — Aix-en-Provence
  • Research Site — Angers
  • Research Site — Aurillac
  • Research Site — Auxerre
  • Research Site — Avignon
  • Research Site — Bezannes
  • Research Site — Béziers
  • Research Site — Blois
  • … и ещё 44 центра

Идентификаторы

NCT: NCT06726720 · D4191R00060

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗