Идёт набор NCT06119581

A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer

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

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: LY3537982, Pembrolizumab, Placebo, Cisplatin.
Кому может быть актуально: Состояния в реестре: Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis. 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

SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression

Обзор

The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.

Подробное описание

Dose Optimization, Part A, and Part B are randomized. Safety Lead-In for Part B is single arm, non-randomized. Part C is non-randomized.

Вмешательства

Препарат LY3537982
Administered orally.
Препарат Pembrolizumab
Administered IV.
Препарат Placebo
Administered orally.
Препарат Cisplatin
Administered IV.
Препарат Carboplatin
Administered IV.
Препарат Pemetrexed
Administered IV.

Первичные конечные точки

Dose Optimization and Safety Lead-In Part B: Number of Participants with a Treatment Emergent Adverse Event(s) (TEAE) [Срок оценки: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)]
Part A and Part B: Progression-Free Survival (PFS) [Срок оценки: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)]

Вторичные конечные точки (12)

Part A and Part B: Overall Survival (OS) [Срок оценки: Randomization to date of death from any cause. (Estimated as up to 3 years)]
Part A and Part B: PFS [Срок оценки: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)]
Part A and Part B: Overall Response Rate (ORR): Percentage of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) [Срок оценки: Randomization to disease progression or death. (Estimated as approximately 1 year)]
Part A and Part B: Duration of Response (DOR) [Срок оценки: Date of first evidence of CR or PR to date of disease progression or death from any cause. (Estimated as approximately 1 year)]
Part A and Part B: Disease Control Rate (DCR): Percentage of Participants who Achieve a BOR of CR, PR, or Stable Disease (SD) [Срок оценки: Randomization to disease progression or death from any cause. (Estimated as approximately 1 year)]
Part A and Part B: Time to Response (TTR) [Срок оценки: Time from randomization until the date that measurement criteria for CR or PR (whichever is first recorded) are first met (Estimated as approximately 1 year)]
Part A and Part B: Intracranial Overall Response Rate (ORR) [Срок оценки: Randomization to intracranial disease progression or death. (Estimated as approximately 1 year)]
Part A and Part B: Intracranial Duration of Response (DoR) [Срок оценки: Date of first evidence of CR or PR to date of intracranial disease progression or death from any cause. (Estimated as approximately 1 year)]
Part A and Part B: PFS2 [Срок оценки: Randomization to disease progression on next line of treatment or death from any cause (Estimated as approximately 1 year]
Part A and Part B: Changes in NSCLC-related symptoms as measured by NSCLC-SAQ [Срок оценки: Randomization through end of treatment (Estimated as approximately 1 year)]]
Part A and Part B: Time to Worsening of NSCLC-related Symptoms as Measured by NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ) [Срок оценки: Randomization through end of treatment (Estimated as approximately 1 year)]
Part A and Part B: Changes in physical function, as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning subscale and IL19 [Срок оценки: Randomization through end of treatment (Estimated as approximately 1 year)]

Критерии участия

Критерии включения

Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy.
Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with pemetrexed label).
Must have disease with evidence of KRAS G12C mutation.
Must have known programmed death-ligand 1 (PD-L1) expression

Part A: Greater than or equal to (≥)50 percent (%).
Part B: 0% to 100%.
Part C: <50%.
Must have measurable disease per RECIST v1.1.
Must have an ECOG performance status of 0 or 1.
Estimated life expectancy ≥12 weeks.
Ability to swallow capsules.
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 a documented additional validated targetable oncogenic driver mutation or alteration in genes such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), BRAF (V600E), human epidermal growth factor receptor 2 (HER2), MET (exon 14), ROS1, rearranged during transfection (RET), or neurotrophic tyrosine receptor kinase (NTRK)1/2/3.
Have had any of the following prior to randomization:

\-- Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC.

\--- 1 cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated:

Have known active central nervous system metastases and/or carcinomatous meningitis.

Exclusion Criteria for Participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B)

Have predominantly squamous cell histology for NSCLC
Only for participants with mild to moderate renal insufficiency: Unable to avoid aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs) two days before (5 days for long acting NSAIDs), day of, and two days after administration of pemetrexed
Is unable or unwilling to take folic acid or vitamin B12 supplementation.

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