Идёт набор NCT06890598

Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer

Фаза III С лечением Carcinoma, Non-Small-Cell Lung

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: В протоколе указаны: Olomorasib, Pembrolizumab, Durvalumab, Placebo.
Кому может быть актуально: Состояния в реестре: Carcinoma, Non-Small-Cell Lung. 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: США, Австралия, Австрия, Бельгия, Бразилия +24
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 Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02

Обзор

The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant.

Вмешательства

Препарат Olomorasib
Administered orally.
Препарат Pembrolizumab
Administered intravenously (IV).
Препарат Durvalumab
Administered IV.
Препарат Placebo
Administered orally.

Первичные конечные точки

Part A: Disease-Free Survival (DFS) by Investigator Assessment [Срок оценки: Randomization to disease recurrence or death from any cause (Estimated as approximately 4 years).]
Part B: Progression-Free Survival (PFS) by BICR [Срок оценки: Randomization to disease progression or death from any cause (Estimated as approximately 3 years).]

Вторичные конечные точки (11)

Part A & B: Overall Survival (OS) [Срок оценки: Randomization to disease progression or death from any cause (Estimated as approximately 5 years).]
Part A & B: Change from baseline in health-related quality of life (HRQoL), measured by European Organization for Research & Treatment of CancerQualityofLifeQuestionnaire-Core 30 (EORTC QLQ-C30) [Срок оценки: Randomization through end of treatment (Estimated as approximately 3 years).]
Part B: PFS by Investigator [Срок оценки: Randomization to disease progression or death from any cause (Estimated as approximately 3 years)]
Part B: Objective Response Rate (ORR) per RECIST 1.1 by BICR and Investigator [Срок оценки: Randomization to disease progression or death from any cause (Estimated as approximately 3 years).]
Part B: Duration of Response (DOR) per RECIST 1.1 by BICR and Investigator [Срок оценки: Randomization to disease progression or death from any cause (Estimated as approximately 3 years).]
Part B: Disease Control Rate (DCR) per RECIST 1.1 by BICR and Investigator [Срок оценки: Randomization to disease progression or death from any cause (Estimated as approximately 3 years).]
Part B: Time to Response (TTR) per RECIST 1.1 by BICR and Investigator [Срок оценки: Randomization until the date that measurement criteria for CR or PR (whichever is first recorded) are first met (Estimated as approximately 3 years).]
Part B: Progression-Free Survival 2 (PFS2) by investigator assessment [Срок оценки: Randomization to disease progression on next line of treatment or death from any cause (Estimated as approximately 3 years).]]
Part B: Changes in Non-Small Cell Lung Cancer (NSCLC)-related symptoms, measured by the NSCLC-Symptom Assessment Questionnaire (SAQ) [Срок оценки: Randomization through end of treatment (Estimated as approximately 3 years).]
Part B: Time to worsening of NSCLC-related symptoms, as measured by NSCLC-SAQ [Срок оценки: Randomization through end of treatment (Estimated as approximately 3 years).]
Part B: Changes in patient-reported pulmonary symptoms of cough, chest pain, and dyspnea, measured by NSCLC-SAQ [Срок оценки: Randomization through end of treatment (Estimated as approximately 3 years).]

Критерии участия

Критерии включения

Histological or cytological confirmation of NSCLC.

Part A

Clinical Stage II-IIIB (N0, N1, N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible.
Pathologic Stage II-IIIB (N0, N1, N2) NSCLC treated with initial upfront resection.
Part B - Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy.
Must have disease with evidence of KRAS G12C mutation.
Must have known programmed death-ligand 1 (PD-L1) expression
Must have an ECOG performance status of 0 or 1.
Able to swallow oral medication.
Must have adequate laboratory parameters.
Contraceptive use should be consistent with local regulations for those participating in clinical studies.
Women of childbearing potential must

Have a negative pregnancy test.
Not be breastfeeding during treatment

Критерии исключения

Have known, actionable changes in the EGFR or ALK genes.
Have another type of cancer that is progressing or required active treatment within the past 2 years before screening.
Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed.
Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Рандомизированное
Модель: Параллельные группы
Маскирование: Двойное слепое
Основная цель: Лечение