Идёт набор NCT06875310

A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

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: Adagrasib, Pembrolizumab, Carboplatin, Pemetrexed.
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, Аргентина, Австралия, Австрия, Бельгия +30
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 Randomized, Double-Blind, Phase 3 Trial of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

Обзор

This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus platinum-doublet chemotherapy in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation

Вмешательства

Препарат Adagrasib
Specified dose on specified days
Препарат Pembrolizumab
Specified dose on specified days
Препарат Carboplatin
Specified dose on specified days
Препарат Pemetrexed
Specified dose on specified days
Препарат Placebo
Specified dose on specified days
Препарат Cisplatin
Specified dose on specified days

Первичные конечные точки

Progression Free Survival (PFS) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded Independent Central Review (BICR) [Срок оценки: Up to 7 years]
Overall Survival (OS) [Срок оценки: Up to 7 years]

Вторичные конечные точки (11)

Overall Response (OR) as Assessed per RECIST v1.1 by BICR [Срок оценки: Up to 7 years]
Duration of Response (DOR) as Assessed per RECIST 1.1 by BICR [Срок оценки: Up to 7 years]
PFS as Assessed per RECIST v1.1 by Investigator [Срок оценки: Up to 7 years]
Number of Participants With Adverse Events (AEs) [Срок оценки: Up to 90 days from last dose]
Number of Participants With Serious Adverse Events (SAEs) [Срок оценки: Up to 90 days from last dose]
Number of Participants With AEs Leading to Dose Interruption [Срок оценки: Up to 90 days from last dose]
Number of Participants With AEs Leading to Dose Reduction [Срок оценки: Up to 90 days from last dose]
Number of Participants With AEs Leading to Treatment Discontinuation [Срок оценки: Up to 90 days from last dose]
Number of Deaths [Срок оценки: Up to 90 days from last dose]
Time to Definitive Deterioration by Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ) Total Score [Срок оценки: Up to 7 years]
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30) Scale/item Score [Срок оценки: Up to 90 days from last dose]

Критерии участия

Критерии включения

Histologically or cytologically confirmed diagnosis of non-squamous NSCLC with evidence of KRAS G12C mutation via tumor sample and/or circulating tumor deoxyribonucleic acid (ctDNA).
Locally advanced or metastatic disease.
Measurable disease via computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria of at least 1 lesion.
No prior systemic anti-cancer therapy given for advanced or metastatic disease.
Not a candidate for definitive therapy (eg, chemoradiation or complete surgical resection).
Participants with brain metastases are eligible for enrollment, including those with untreated brain metastases. Brain metastases must be asymptomatic and not in need of immediate local therapy. Any untreated brain metastases must be ≤ 20 mm in diameter.
Any PD-L1 expression (0 to 100%) as determined by VENTANA PD-L1 (SP263) assay, Agilent PD-L1 IHC 22C3 pharmDx, or Agilent PD-L1 IHC 28-8 pharmDx.

Критерии исключения

Participants with an active autoimmune or inflammatory disease requiring systemic treatment within 2 years.
Uncontrolled or significant cardiovascular conditions within 6 months prior to enrollment that are ongoing or with risk of recurrence.
Inadequate bone marrow or liver function or electrocardiogram (ECG) abnormalities.
Ongoing treatment with concomitant medication known to cause prolonged QTc interval and that cannot be switched to alternative treatment prior to study entry.
Treatment targeting KRAS G12C mutation (eg, sotorasib, adagrasib) in any setting.
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration.
Other protocol-defined Inclusion/Exclusion criteria apply.

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: Четверное слепое
Основная цель: Лечение