Исследование комбинированной терапии амивантамабом и оломорасибом у пациентов с метастатическим немелкоклеточным раком легкого (KaRAnaSa)
Фаза 1/2 исследования по оценке безопасности и эффективности комбинированной терапии амивантамабом и оломорасибом при метастатическом немелкоклеточном раке легкого
The main purpose of this study is to find out the most suitable dose (recommended phase 2 combination dose [RP2CD]) of amivantamab and olomorasib combination therapy and to assess how well the combination slows down or prevents the growth of tumors in participants with KRAS G12C mutant metastatic non-small cell lung cancer (NSCLC: the most common type of lung cancer; metastatic: has spread to other parts of the body; KRAS G12C mutant: mutation [change] in the kirsten rat sarcoma viral oncogene homolog [KRAS] gene in tumor cells in which glycine [G] at position 12 is replaced with cystine [C]).
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 2
- Фаза 1
Контакты и местонахождение
Контакты исследования
- Имя: Study Contact
- Номер телефона: 844-434-4210
- Электронная почта: Participate-In-This-Study1@its.jnj.com
Места учебы
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Ontario
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Toronto, Ontario, Канада, M5G 2M9
- Рекрутинг
- Princess Margaret Hospital
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Guangzhou, Китай, 510060
- Рекрутинг
- The First Affiliated Hospital Sun Yat sen University
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Harbin, Китай, 150000
- Рекрутинг
- Harbin medical university cancer hospital
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Shanghai, Китай, 310000
- Рекрутинг
- Shanghai East Hospital
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New York
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New York, New York, Соединенные Штаты, 10016
- Рекрутинг
- New York University Langone Medical Center
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Virginia
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Fairfax, Virginia, Соединенные Штаты, 22031
- Рекрутинг
- Virginia Cancer Specialists
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Ankara, Турция (Туркие), 06620
- Рекрутинг
- Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi
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Istanbul, Турция (Туркие), 34010
- Рекрутинг
- Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi
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Çankaya, Турция (Туркие), 06800
- Рекрутинг
- Ankara Bilkent Sehir Hastanesi
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Seoul, Южная Корея, 05505
- Рекрутинг
- Asan Medical Center
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Seoul, Южная Корея, 06351
- Рекрутинг
- Samsung Medical Center
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Seoul, Южная Корея, 03722
- Рекрутинг
- Severance Hospital Yonsei University Health System
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion criteria:
- Participant must have histologically or cytologically confirmed metastatic NSCLC characterized by a KRAS G12C mutation at the time of enrollment. For Phase 1: Participant must have progressed on or after, or have intolerance to, platinum-based chemotherapy and Programmed Death-Ligand 1 (PD-L1)-targeted immunotherapy given in combination or sequentially. Receipt of additional lines of prior therapy is permitted. Progression must have occurred on or after the most recent line of systemic anticancer therapy. For Phase 2: Participant must have progressed on or after platinum-based chemotherapy and PD-L1-targeted immunotherapy given in combination or sequentially. Progression must have occurred on or after the most recent line of systemic anticancer therapy. Receipt of additional lines of prior therapy is not permitted
- Participant must have at least 1 measurable lesion, according to RECIST version.1.1, that has not been previously irradiated
- May have brain metastases only if previously definitively, locally treated, and participant is clinically stable and asymptomatic for greater than (>) 2 weeks and is off or receiving low-dose corticosteroid treatment for at least 2 weeks prior to start of study treatment
- Can have a prior or concurrent second malignancy (other than the disease under study) with natural history or treatment course that is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion criteria:
- Participant has history of uncontrolled illness
- Suspected or known allergies, hypersensitivity, or intolerance to amivantamab excipients or olomorasib excipients
- Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
- Presence of primary driver mutations (epidermal growth factor receptor [EGFR], anaplastic lymphoma kinase [ALK], mesenchymal-epithelial transition [MET], human epidermal growth factor receptor 2 [HER2], ROS1, neurotrophic tyrosine receptor kinase [NTRK], B-Raf proto-oncogene [BRAF], rearranged during Transfection [RET], neuroblastoma RAS viral oncogene homolog [NRAS], and other KRAS mutations besides G12C) as determined by local genomic testing
- Prior treatment with any KRAS inhibitor
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Последовательное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Phase 1: Combination Dose Selection
Participants will receive amivantamab along with olomorasib to determine the RP2CD of the combination therapy until disease progression, significant toxicity, or until another criterion for discontinuation of study treatment is met. Eligible participants may have the option to transfer to a long-term extension (LTE) phase for continued access to study treatments. |
Amivantamab will be administered.
Другие имена:
Olomorasib will be administered.
Другие имена:
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Экспериментальный: Phase 2: Expansion
Participants will receive amivantamab and olomorasib combination therapy at the RP2CD determined in Phase 1 until disease progression, significant toxicity, or until another criterion for discontinuation of study treatment is met. Eligible participants may have the option to transfer to LTE phase for continued access to study treatments. |
Amivantamab will be administered.
Другие имена:
Olomorasib will be administered.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Phase 1: Number of Participants with Adverse Events (AEs) by Severity
Временное ограничение: Up to approximately 3 years 2 months
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An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An assessment of severity grade will be made by the investigator according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 defined as follows: Grade 1 (mild; asymptomatic or mild symptoms; intervention not indicated); Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living [ADL]); Grade 3 (severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 (life-threatening consequences; urgent intervention indicated); Grade 5 (Death related to adverse event). |
Up to approximately 3 years 2 months
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Phase 1: Number of Participants with Dose-Limiting Toxicities (DLTs)
Временное ограничение: Up to approximately 3 years 2 months
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DLT is defined as drug related adverse events and includes unacceptable non-hematologic toxicity, hematologic toxicity, pulmonary toxicity, or elevations in hepatic enzymes suggestive of drug-induced liver injury of Grade 3 or higher. Toxicities will be graded for severity according to the NCI-CTCAE, version 5.0. |
Up to approximately 3 years 2 months
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Phase 2: Confirmed Objective Response Rate (ORR)
Временное ограничение: Up to approximately 3 years 2 months
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ORR is defined as the percentage of participants who achieve either a confirmed partial response (PR) or complete response (CR), using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 by investigator review. Confirmatory analysis may be performed using Blinded Independent Central Review (BICR). |
Up to approximately 3 years 2 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Number of Participants with Adverse Events (AEs) by Severity
Временное ограничение: Up to approximately 3 years 2 months
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An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An assessment of severity grade will be made by the investigator according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 defined as follows: Grade 1 (mild; asymptomatic or mild symptoms; intervention not indicated); Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living [ADL]); Grade 3 (severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 (life-threatening consequences; urgent intervention indicated); Grade 5 (Death related to adverse event). |
Up to approximately 3 years 2 months
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Number of Participants with Abnormalities in Clinical Laboratory Parameters
Временное ограничение: Up to approximately 3 years 2 months
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Number of participants with abnormalities in clinical laboratory values (which includes serum chemistry, hematology, coagulation, urinalysis, and serology) will be reported. |
Up to approximately 3 years 2 months
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Phase 2: Duration of Response (DoR)
Временное ограничение: Up to approximately 3 years 2 months
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DoR is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death from any case, whichever comes first, for participant who have PR or CR according to RECIST v1.1 by investigator review. |
Up to approximately 3 years 2 months
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Phase 2: Disease Control Rate (DCR)
Временное ограничение: Up to approximately 3 years 2 months
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DCR is defined as the percentage of participants who achieve a PR, CR, or stable disease using RECIST v1.1. |
Up to approximately 3 years 2 months
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Phase 2: Progression-Free Survival (PFS)
Временное ограничение: Up to approximately 3 years 2 months
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PFS is defined as the time from first dose date until the date of disease progression or death, whichever comes first, based on investigator assessment using RECIST v1.1 by investigator review. |
Up to approximately 3 years 2 months
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Phase 2: Overall Survival (OS)
Временное ограничение: Up to approximately 3 years 2 months
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OS is defined as the time from the date of administration of the first dose of study treatment until the date of death due to any cause. |
Up to approximately 3 years 2 months
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Соавторы и исследователи
Следователи
- Директор по исследованиям: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 61186372PANSC2004
- 61186372PANSC2004 (Другой идентификатор: Janssen Research & Development, LLC)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
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