Идёт набор NCT06899126

Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer

Фаза III С лечением Non-small Cell Lung Cancer

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: Trastuzumab Deruxtecan, pembrolizumab, Pemetrexed, Platinum Chemotherapy.
Кому может быть актуально: Состояния в реестре: Non-small Cell Lung Cancer. 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, Бельгия, Бразилия, Чили +18
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, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination With Pembrolizumab Versus Platinum-based Chemotherapy in Combination With Pembrolizumab, as First-line Therapy in Participants With Locally Advanced Unresectable or Metastatic HER2 Overexpressing and PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer (DESTINY-Lung06)

Обзор

This clinical trial is designed to assess the efficacy and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS \<50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced/metastatic setting.

Вмешательства

Препарат Trastuzumab Deruxtecan
T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)
Препарат pembrolizumab
pembrolizumab will be administered at a dose of 200 mg IV Q3W
Препарат Pemetrexed
Pemetrexed will be administered at a dose of 500 mg/m\^2 IV Q3W
Препарат Platinum Chemotherapy
One of the following two will be administered in Arm B: Cisplatin at a dose of 75 mg/m\^2 IV or carboplatin AUC at a dose of 5 mg/mL/min IV Q3W

Первичные конечные точки

Progression Free Survival by Blinded Independent Central Review [Срок оценки: From date of randomization to the date of radiographic disease progression or death due to any cause, up to approximately 54 months]

Вторичные конечные точки (1)

Overall Survival [Срок оценки: From date of randomization to the date of death due to any cause, up to approximately 85 months]

Критерии участия

Критерии включения

Sign and date the Tissue Screening ICF, prior to any Tissue Screening procedure. Sign and date the Main ICF, prior to the start of any trial-specific qualification procedures.

Sign and date the Optional PGx ICF (included in the Main ICF) prior to any PGx procedure, and the Pregnant Partner ICF, if applicable.

Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is >18 years old.
Histologically documented non-squamous locally advanced unresectable or metastatic

NSCLC and meets all of the following criteria:

Has Stage IV NSCLC disease or Stage IIIB or IIIC disease but is not a candidate for surgical resection or definitive chemoradiation at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition). Has no known AGAs (based on the local test results obtained using validated or approved tests as required per local regulation) that have locally available therapies targeting their AGAs in the first-line advanced/metastatic setting.

Has no known HER2 mutation based on existing test results (if approved or validated local test is available). Note: Participants with mixed histology are eligible if non-squamous NSCLC is the predominant histology. Mixed tumors will be classified based on the predominant cell type.

Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC. Participants who received adjuvant or neoadjuvant therapy other than those listed below, including ICI (ie, anti-PD-1/PD-L1) or a platinum-based regimen, are eligible if the last dose of adjuvant/neoadjuvant therapy was given at least 6 months before the date of the first trial dose if their disease has progressed at least 6 months after the last dose date of adjuvant/neoadjuvant therapy.

Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I.
HER2-targeted antibody-based anticancer therapy.
Has adequate tumor tissue sample (not previously irradiated) available for assessment of HER2 and PD-L1 expression by central or Sponsor-specified laboratory. A new biopsy is required if the participant's most recent archival tumor tissue sample cannot be supplied.

Details pertaining to tumor tissue submission can be found in the Trial Laboratory Manual.

Критерии исключения

Has a medical history of MI within 6 months before randomization/enrollment or symptomatic CHF (NYHA Class II to Class IV). Participants with troponin levels above the ULN at Screening (as defined by the manufacturer) and without any MI-related symptoms must be ruled out for MI. It is highly recommended that the investigator refer such participants for a cardiologic consultation during the Screening Period.
Has a QTc prolongation to >480 ms based on the average of the Screening triplicate 12- lead ECG.
Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
Has clinically severe pulmonary compromise resulting from intercurrent, pulmonary illnesses including, but not limited to:

Any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe COPD, restrictive lung disease, pleural effusion).
Any auto immune, connective tissue, or inflammatory disorders with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis).

Severe conditions are those defined as impacting daily activities and/or requiring use of supplemental oxygen.

Had a prior complete pneumonectomy.

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

Китай · 31 центр

Beijing Cancer Hospital — Пекин
China-Japan Friendship hospital — Пекин
Jilin Cancer Hospital — Changchun
The First Hospital of Jilin University — Changchun
Hunan Cancer Hospital — Чанша
Sichuan Cancer Hospital — Чэнду
West China Hospital, Sichuan University — Чэнду
Chongqing University Cancer Hospital — Чунцин
… и ещё 23 центра

США · 26 центров

Alaska Oncology & Hematology, LLC — Anchorage
Orange Coast Memorial Medical Center Fountain Valley — Fountain Valley
California Research Institute — Los Angeles
Los Angeles Cancer Network (LACN) — Los Angeles
Providence Medical Foundation — Santa Rosa
Bay Pines VA Healthcare System — Bay Pines
Lynn Cancer Institute Center — Boca Raton
Holy Cross Hospital — Fort Lauderdale
… и ещё 18 центров

Япония · 22 центра