Идёт набор NCT06667076

A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Фаза II 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: Amivantamab, Lazertinib, Chemotherapy: Pemetrexed, Chemotherapy: Carboplatin.
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, Бельгия, Финляндия, Франция, Германия +9
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 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Обзор

The primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).

Вмешательства

Препарат Amivantamab
Amivantamab will be administered.
Препарат Lazertinib
Lazertinib tablet will be administered.
Препарат Chemotherapy: Pemetrexed
Pemetrexed will be administered.
Препарат Chemotherapy: Carboplatin
Carboplatin will be administered.

Первичные конечные точки

Progression Free Survival (PFS) [Срок оценки: Up to 4 Years and 6 months]

Вторичные конечные точки (11)

Number of Participants Reporting Dose Reductions, Interruptions, and Discontinuations [Срок оценки: Up to 4 Years and 6 months]
Number of Participants With Venous Thromboembolic Events (VTEs) [Срок оценки: Up to 4 Years and 6 months]
Number of Participants With Dermatologic Adverse Events (AEs) [Срок оценки: Up to 4 Years and 6 months]
Number of Participants with AEs by Severity [Срок оценки: Up to 4 Years and 6 months]
Overall Survival (OS) [Срок оценки: Up to 4 Years and 6 months]
Overall Response Rate (ORR) [Срок оценки: Up to 4 Years and 6 months]
Clinical Benefit Rate (CBR) [Срок оценки: Up to 4 Years and 6 months]
Duration of Response (DOR) [Срок оценки: Up to 4 Years and 6 months]
Time to Treatment Discontinuation (TTTD) [Срок оценки: Up to 4 Years and 6 months]
Time to Subsequent Therapy (TTST) [Срок оценки: Up to 4 Years and 6 months]
Time to Symptomatic Progression (TTSP) [Срок оценки: Up to 4 Years and 6 months]

Критерии участия

Критерии включения

Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to curative intent therapy
Epidermal growth factor resistance-mutation (EGFRm) must be an Ex19del or Ex21 L858R substitution, as detected by food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory (sites in the US), or an accredited local laboratory (sites outside of the US) in accordance with site standard of care. In the European union (EU), the local test must be Conformité Européenne (CE)-marked or an in-house laboratory-developed test from health institutions in the EU in accordance with Article 5(5) of the in vitro diagnostic regulations (IVDR ) 2071/746, as amended
Have at least 1 measurable lesion, according to RECIST version (v)1.1, that has not been previously irradiated
Any toxicities from prior systemic anticancer therapy must have resolved to national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0 grade 1 or baseline level (except for alopecia \[any grade\], grade <=2 peripheral neuropathy, or grade <=2 hypothyroidism stable on hormone replacement)
Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Критерии исключения

Medical history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis. Participants with medical history of radiation pneumonitis, including radiation pneumonitis which required steroid treatment, should consult with the medical monitor and eligibility be assessed on a case-by-case basis
Had major surgery excluding placement of vascular access or tumor biopsy or had significant traumatic injury within 4 weeks before the first dose of anticancer treatments or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
Participant has uncontrolled tumor-related pain (symptomatic lesions amenable to palliative radiotherapy should be treated prior to first dosing)
Received an investigational treatment that has not been cleared (based on at least 5 half lives of any pharmaceutical treatment) before the planned first dose of study treatment or is currently enrolled in an investigational study
Has a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Нерандомизированное
Модель: Параллельные группы
Маскирование: Открытое
Основная цель: Лечение