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| Протокол № | D5169C00001 D5169C00001 № D5169C00001 |
| Тип: | ММКИ |
| Фаза: | III |
| РКИ № | 287 от 4 июня 2019 г. |
| Начало: | 4 июня 2019 г. |
| Окончание: | 15 апреля 2026 г. |
| Пациентов: | 120 |
| Наименование протокола: | Открытое рандомизированное исследование III фазы осимертиниба, с химиотерапией на основе препаратов платины в комбинации с пеметрекседом или без неё, в качестве первой линии лечения у пациентов с местнораспространённым или метастатическим немелкоклеточным раком лёгкого при положительном статусе по мутациям в рецепторе эпидермального фактора роста (EGFR) (FLAURA2) |
| Цель исследования: | Изучить безопасность и переносимость осимертиниба в комбинации с химиотерапией у пациентов с раком лёгкого |
| Препарат(ы): | Осимертиниб (AZD9291, Тагриссо) |
| Лекарственная форма: | Таблетки, покрытые пленочной оболочкой 40 мг, 80 мг |
| Разработчик: | АстраЗенека АБ |
| Страна: | Швеция |
| CRO: | ООО "АстраЗенека Фармасьютикалз", 125284, Москва, ул. Беговая д.3 стр.1, ~ |
| Терапевтические области: | Онкология;Пульмонология; |
Дополнительная информация:
ClinicalTrials.gov A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)
| Статус: | Active, not recruiting |
| Фаза: | Phase 3 |
| Начало: | 2 июля 2019 г. |
| Окончание: | 3 июня 2026 г. |
| Описание: | The reason for the study is to find out if an experimental combination of an oral medication called osimertinib (TAGRISSO®) when used in combination with chemotherapy is more effective than giving osimertinib alone for the treatment of locally advanced or metastatic non-small cell lung cancer. Some lung cancers are due to mutations in the Deoxyribonucleic acid (DNA) which, if known, can help physicians decide the best treatment for their patients. One type of mutation can occur in the gene that produces a protein on the surface of cells called the Epidermal Growth Factor Receptor (EGFR). Osimertinib is an Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets Epidermal Growth Factor Receptor (EGFR) mutations. Unfortunately, despite the benefit observed for patients treated with osimertinib, the vast majority of cancers are expected to develop resistance to the drug over time. The exact reasons why resistance develops are not fully understood but based upon clinical research it is hoped that combining osimertinib with another type of anti-cancer therapy known as chemotherapy will delay the onset of resistance and the worsening of a patient's cancer. In total the study aims to enroll approximately 586 patients, consisting of approximately 30 patients who will participate in a safety run-in component of the trial, and approximately 556 who will receive osimertinib alone or osimertinib in combination with chemotherapy in the main trial. In the main part of the trial there is a one in two chance of receiving osimertinib alone, and the treatment is decided at random by a computer. The study involves a Screening Period, Treatment Period, and Follow up Period. Whilst receiving study medication, it is expected patients will attend, on average, approximately 15 visits over the first 12 months and then approximately 4 visits per year afterwards. Each visit will last about 2 to 6 hours depending on the arrangement of medical assessments by the study centre. |
| смотреть на ClinicalTrials.gov |