Идёт набор NCT06452277

A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

Фаза III С лечением Advanced Non-small Cell Lung Cancer, HER2 Mutation

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: Sevabertinib, Pembrolizumab, Cisplatin, Carboplatin.
Кому может быть актуально: Состояния в реестре: Advanced Non-small Cell Lung Cancer, HER2 Mutation. 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 +31
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 Open-label, Randomized, Active-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Orally Administered BAY 2927088 Compared With Standard of Care as a First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With HER2-activating Mutations

Обзор

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations. Advanced NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body or that are unlikely to be cured or controlled with currently available treatments. HER2 is a protein that helps cells to grow and divide. A damage (also called mutation) to the building plans (genes) for this protein in cancer cells leads to a production of abnormal HER2 and therefore abnormal cell growth and division. The study treatment, sevabertinib, is expected to block the mutated HER2 protein which may stop the spread of NSCLC. The main purpose of this study is to learn how well sevabertinib works and how safe it is compared with standard treatment, in participants who have advanced NSCLC with specific genetic changes called HER2 mutations. The study participants will receive one of the study treatments: * Sevabertinib twice every day as a tablet by mouth, or * Standard treatment in cycles of 21 days via infusion ("drip") into the vein. * Participants will continue their assigned treatment for as long as they benefit from it and do not experience severe side effects, or until they or their doctor decide to stop treatment. When a participant receiving the standard treatment has their disease get worse (this is called "disease progression"), they may have the opportunity to switch ("cross over") to receive sevabertinib. * Participants who switch to sevabertinib will continue this treatment until their disease gets worse again, they have side effects that are too severe, or they or their doctor decide to stop treatment. During the study, the doctors and their study team will: * take imaging scans, including CT, PET, MRI, and X-rays, of different parts of the body to study the spread of cancer * check the overall health of the participants by performing tests such as blood and urine tests, and checking * heart health using an electrocardiogram (ECG) * perform pregnancy tests for women * ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

Вмешательства

Препарат Sevabertinib
Tablet, oral
Препарат Pembrolizumab
Intravenous (IV) infusion
Препарат Cisplatin
IV infusion
Препарат Carboplatin
IV infusion
Препарат Pemetrexed
IV infusion

Первичные конечные точки

Progression free survival (PFS) per RECIST 1.1 as assessed by BICR [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (12)

Overall survival (OS) [Срок оценки: Up to approximately 4 years.]
Objective response rate (ORR) per RECIST 1.1 as assessed by BICR [Срок оценки: Up to approximately 4 years]
Progression free survival (PFS) per RECIST 1.1 as assessed by the investigator [Срок оценки: Up to approximately 4 years]
Objective Response Rate (ORR) per RECIST 1.1 as assessed by the investigator [Срок оценки: Up to approximately 4 years]
Disease control rate (DCR) per RECIST 1.1 as assessed by BICR [Срок оценки: Up to approximately 4 years]
Disease control rate (DCR) per RECIST 1.1 as assessed by the investigator [Срок оценки: Up to approximately 4 years]
Duration of response (DOR) as assessed by BICR [Срок оценки: Up to approximately 4 years]
Duration of response (DOR) as assessed by the investigator [Срок оценки: Up to approximately 4 years]
Adverse events per CTCAE v 5.0 (eg. TEAEs, TESAEs) categorized by severity [Срок оценки: Up to approximately 4 years]
Change from baseline in NSCLC-SAQ total score [Срок оценки: Up to approximately 4 years]
Change from baseline in NSCLC-SAQ individual domain scores [Срок оценки: Up to approximately 4 years]
Time to deterioration in NSCLC-SAQ total score [Срок оценки: Up to approximately 4 years]

Критерии участия

Критерии включения

Participant must be ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signing the informed consent.
Documented histologically or cytologically confirmed locally advanced non-squamous NSCLC, not suitable for definitive therapy or metastatic non-squamous NSCLC at screening (small cell or mixed histologies are excluded) (Stage III-IV NSCLC).
Documented activating HER2 mutation in the tyrosine kinase domain (TKD) assessed by tissue molecular test in a CLIA-certified (US sites) or an equally accredited (outside of the US) local laboratory. However, participants may be included at the discretion of the investigator if the laboratory performing the assay is not CLIA or similar certified but the laboratory is locally accredited.
No prior systemic therapy for locally advanced or metastatic disease. No prior treatment with a HER2 ex20ins-targeted therapy (e.g. poziotinib, trastuzumab deruxtecan). Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the start of screening.
Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in accordance with the SmPC/Product Information.

Критерии исключения

Known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for five years since initiation of that therapy. Exception: the following cancer types are acceptable within five years if curatively treated or under surveillance:

a. in situ cancers of cervix, breast, or skin,
b. superficial bladder cancer (Ta, Tis and T1),
c. limited-stage prostate cancer,
d. basal or squamous cancers of the skin.
Tumors with targetable alterations with approved available therapy, with the exception of HER2 mutation in the TKD.
Inability to discontinue treatment with chronic systemic corticosteroids. Participants who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study. Replacement therapy (e.g., physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is acceptable, provided that the dose is stable for >4 weeks prior to planned start of study intervention.
Pre-existing peripheral neuropathy that is Grade ≥2 by CTCAE (v5.0).
History of severe hypersensitivity reaction to treatment with a monoclonal antibody.
Prior radiotherapy outside of the brain within 21 days before of planned start of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.

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: Открытое
Основная цель: Лечение

Центры проведения

США · 27 центров

Patty & George Hoag Cancer Center — Newport Beach
UC San Diego Health - Moores Cancer Center — San Diego
UCSF Bakar Precision Cancer Medicine Building - Thoracic Surgery and Oncology — San Francisco
UCLA Health Santa Monica Cancer Care — Santa Monica
The Oncology Institute of Hope and Innovation - Fort Lauderdale 17th Street — Fort Lauderdale
Memorial Cancer Institute at Miramar — Miramar
AdventHealth Cancer Institute Orlando — Orlando
Moffitt Cancer Center - Magnolia Campus — Tampa
… и ещё 19 центров

Китай · 25 центров

Cancer Hospital, Chinese Academy of Medical Sciences — Пекин
Beijing Cancer Hospital - Oncology Department — Пекин
Beijing Hospital — Пекин
The People's Liberation Army General Hospital (Beijing 301 Hospital) — Пекин
Beijing chest hospital, Capital Medical University — Пекин
Fujian Cancer Hospital — Фучжоу
Xiamen University - The First Affiliated Hospital — Xiamen
The first Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
… и ещё 17 центров

Италия · 18 центров