Расширенная дерматологическая помощь для уменьшения сыпи и паронихии при немелкоклеточном раке легких с мутацией рецептора эпидермального фактора роста (EGRF) (НМРЛ), лечение первой линии амивантамабом плюс лазертинибом (COCOON)
Открытое рандомизированное исследование фазы 2, оценивающее влияние усиленного и стандартного дерматологического лечения на отдельные дерматологические нежелательные явления среди пациентов с местнораспространенным или метастатическим НМРЛ с мутацией EGFR, получавших лечение первой линии амивантамабом + лазертинибом
The purpose of this study is to evaluate whether enhanced dermatologic management can reduce incidence of grade greater than or equal to (>=) 2 dermatologic adverse events of interest (DAEIs) when compared with standard-of-care skin management and with modified enhanced dermatologic management in participants with locally advanced or metastatic stage IIIB/C-IV epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) treated first-line with amivantamab and lazertinib. The study also includes Expansion cohorts (in 2 different schedules) to evaluate enhanced dermatologic management and early intervention for DAEIs or paronychia, in participants receiving subcutaneous amivantamab and lazertinib. A substudy will enroll participants from Arms A and B who experience specific new-onset or persistent DAEIs (Grade >=2) during treatment with intravenous (IV) amivantamab and lazertinib. This substudy aims to assess the reactive use of dermatologic treatment strategies in these participants.
Обзор исследования
Статус
Вмешательство/лечение
- Лекарство: Amivantamab IV
- Лекарство: Lazertinib
- Лекарство: Doxycycline
- Лекарство: Minocycline
- Лекарство: Clindamycin
- Лекарство: Chlorhexidine
- Другой: Noncomedogenic skin moisturizer
- Другой: Ruxolitinib
- Другой: Tacrolimus
- Лекарство: Amivantamab SC
- Лекарство: Zinc gluconate
- Лекарство: Propranolol
- Лекарство: Timolol
- Лекарство: Clobetasol
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 2
Контакты и местонахождение
Места учебы
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Buenos Aires, Аргентина, C1199
- Hospital Italiano de Buenos Aires
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CABA, Аргентина, C1122
- IADT Instituto Argentino de Diagnostico y Tratamiento
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Capital Federal, Аргентина, C1017
- Centro Medico Austral
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La Plata, Аргентина, B1900AXI
- Hospital Italiano de La Plata
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Mar del Plata, Аргентина, B7602
- Hospital Privado de la Comunidad
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Belo Horizonte, Бразилия, 30150-221
- Santa Casa de Misericordia de Belo Horizonte
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Belém, Бразилия, 66.073-005
- CTO Centro De Tratamento Oncologico LTDA
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Curitiba, Бразилия, 81520-060
- Liga Paranaense de Combate ao Cancer
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Jaú, Бразилия, 17.210-080
- Fundacao Doutor Amaral Carvalho
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Porto Alegre, Бразилия, 91350 200
- Hospital Nossa Senhora da Conceicao S A
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Salvador, Бразилия, 40170 070
- Nucleo de Oncologia da Bahia Oncoclinicas
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Santa Cruz do Sul, Бразилия, 96835-100
- Hospital Ana Nery Santa Cruz do Sul
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São Paulo, Бразилия, 01509 900
- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, Бразилия, 01246 000
- Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
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Taubaté, Бразилия, 12030-200
- Servicos de Tratamento ao Cancer de Taubate LTDA - Instituto do Cancer Brasil Unidade Taubate
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Vitória, Бразилия, 29043-260
- Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
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Aachen, Германия, 52074
- Universitaetsklinikum der RWTH Aachen
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Essen, Германия, 45136
- Kliniken Essen-Mitte
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Giessen, Германия, 35392
- Universitaetsklinikum Giessen und Marburg GmbH
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Heidelberg, Германия, 69126
- Thoraxklinik am Universitatsklinikum Heidelberg
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Kassel, Германия, 34125
- Klinikum Kassel GmbH
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Kiel, Германия, 24105
- Universitaetsklinikum Schleswig Holstein Campus Kiel
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A Coruña, Испания, 15006
- Hosp Univ A Coruna
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Alicante, Испания, 03010
- Hosp. Gral. Univ. de Alicante
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Barcelona, Испания, 08028
- Hosp. Univ. Quiron Dexeus
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Barcelona, Испания, 08035
- Hosp Univ Vall D Hebron
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Jaén, Испания, 23007
- Hosp. Univ. de Jaen
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Lugo, Испания, 27003
- Hosp. Univ. Lucus Augusti
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Madrid, Испания, 28007
- Hosp. Gral. Univ. Gregorio Maranon
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Málaga, Испания, 29010
- Hosp Regional Univ de Malaga
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Seville, Испания, 41014
- Hosp. Ntra. Sra. de Valme
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Changzhou, Китай, 213004
- Changzhou No 2 Peoples Hospital
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Chengdoucun, Китай, 610041
- West China Hospital
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Chengdu, Китай, 610041
- Sichuan Cancer Hospital
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Guangzhou, Китай, 510080
- The First Affiliated Hospital Sun Yat sen University
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Hangzhou, Китай, 310003
- The First Affiliated Hospital Zhejiang University School of Medicine
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Harbin, Китай, 150040
- Harbin medical university cancer hospital
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Huizhou, Китай, 516001
- Huizhou Municipal Central Hospital
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Nanjing, Китай, 210000
- Zhongda Hospital Southeast University
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Shanghai, Китай, 200032
- Fudan University Shanghai Cancer Center
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Xi'an, Китай, 710061
- The First Affiliated Hospital of Xian Jiaotong University
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Zhengzhou, Китай, 450008
- Henan Cancer Hospital
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George Town, Малайзия, 10450
- Hospital Pulau Pinang
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Kuala Lumpur, Малайзия, 59100
- University Malaya Medical Centre
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Kuantan, Малайзия, 25100
- Hospital Tengku Ampuan Afzan
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Kuching, Малайзия, 93586
- Hospital Umum Sarawak
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Arizona
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Chandler, Arizona, Соединенные Штаты, 85224
- Ironwood Cancer and Research Center
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California
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Duarte, California, Соединенные Штаты, 91010
- City of Hope
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Fullerton, California, Соединенные Штаты, 92835
- Providence Fullerton
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Glendale, California, Соединенные Штаты, 91204
- Los Angeles Cancer Network
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Huntington Beach, California, Соединенные Штаты, 92648
- City of Hope Seacliff
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Irvine, California, Соединенные Штаты, 92618
- City of Hope Orange County Lennar Foundation Cancer Center
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Long Beach, California, Соединенные Штаты, 90813
- City of Hope Long Beach Elm
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Los Alamitos, California, Соединенные Штаты, 90720
- Cancer and Blood Specialty Clinic
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Los Angeles, California, Соединенные Штаты, 90033
- Keck Hospital of USC
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Newport Beach, California, Соединенные Штаты, 92663
- USC Norris Oncology Hematology Newport Beach
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Oakland, California, Соединенные Штаты, 94611
- Kaiser Permanente Oakland Medical Center
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Roseville, California, Соединенные Штаты, 95661
- Kaiser Permanente Roseville Medical Center
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San Francisco, California, Соединенные Штаты, 94115
- Kaiser Permanente San Francisco Medical Center
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Santa Clara, California, Соединенные Штаты, 95051
- Kaiser Permanente Santa Clara Medical Center
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South Pasadena, California, Соединенные Штаты, 91030
- City of Hope South Pasadena
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Vallejo, California, Соединенные Штаты, 94589
- Kaiser Permanente Northern California
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Walnut Creek, California, Соединенные Штаты, 94596
- Kaiser Permanente Walnut Creek Medical Center
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Georgia
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Athens, Georgia, Соединенные Штаты, 30607
- University Cancer & Blood Center
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Illinois
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Hinsdale, Illinois, Соединенные Штаты, 60521
- Hope and Healing Care
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Missouri
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Springfield, Missouri, Соединенные Штаты, 65807
- Oncology Hematology Associates
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Nevada
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Reno, Nevada, Соединенные Штаты, 89502
- Renown Health Medical Oncology
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New Jersey
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Flemington, New Jersey, Соединенные Штаты, 08822
- Hunterdon Hematology Oncology
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New York
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Westbury, New York, Соединенные Штаты, 11590
- Clinical Research Alliance Inc
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North Carolina
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Wilson, North Carolina, Соединенные Штаты, 27893
- Regional Medical Oncology Center
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Ohio
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Cleveland, Ohio, Соединенные Штаты, 44106
- University Hospitals Cleveland Medical Center
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Virginia
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Fairfax, Virginia, Соединенные Штаты, 22031
- Virginia Cancer Specialists
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Washington
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Renton, Washington, Соединенные Штаты, 98055
- Valley Medical Center
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Wisconsin
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West Salem, Wisconsin, Соединенные Штаты, 54669
- Gundersen Health System
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Hsinchu, Тайвань, 30059
- National Taiwan University Hospital Hsin Chu Branch
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Kaohsiung City, Тайвань, 833
- Chang Gung Memorial Hospital
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Taichung, Тайвань, 40705
- Taichung Veterans General Hospital
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Taipei, Тайвань, 100
- National Taiwan University Hospital
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Taoyuan City, Тайвань, 333
- Linkou Chang Gung Memorial Hospital
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Adana, Турция (Туркие), 1060
- Adana City Hospital
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Ankara, Турция (Туркие), 06560
- Gazi University Hospital
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Ankara, Турция (Туркие), 06010
- Gulhane Training and Research Hospital
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Ankara, Турция (Туркие), 6800
- Ankara Bilkent City Hospital
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Istanbul, Турция (Туркие), 34147
- Bakirkoy Training and Research Hospital
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Istanbul, Турция (Туркие), 34295
- I A U VM Medical Park Florya Hastanesi
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Izmir, Турция (Туркие), 35100
- Ege University Medical Faculty
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Samsun, Турция (Туркие), 55420
- Ondokuz Mayis University
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Marseille, Франция, 13915
- Hopital Nord
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Nice, Франция, 06001
- Hopital PASTEUR
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Paris, Франция, 75005
- Institut Curie
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Cheongju-si, Южная Корея, 28644
- Chungbuk National University Hospital
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Incheon, Южная Корея, 21565
- Gachon University Gil Medical Center
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Seoul, Южная Корея, 03722
- 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:
- Have histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC); Is treatment naive and not amenable to curative therapy including surgical resection or (chemo) radiation. Adjuvant or neoadjuvant therapy for Stage I, Stage II or Stage IIIA disease is allowed if last dose administered more than 12 months prior to the development of locally advanced or metastatic disease
- Have a tumor that harbors an epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution, as detected by an Food and Drug Administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory (sites in the United States) or an accredited local laboratory (sites outside of the United States) in accordance with site standard-of-care
- A participant with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants with a history of symptomatic brain metastases must have had all lesions treated as clinically indicated (that is, no current indication for further definitive local therapy). Any definitive local therapy to brain metastases must have been completed at least 14 days prior to randomization, and the participant can be receiving no greater than 10 milligram (mg) prednisone or equivalent daily for the treatment of intracranial disease
- Can have prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints, safety, or the efficacy of the study treatment(s). For the amivantamab SC expansion cohorts: Due to the increased risk of skin cancer with ruxolitinib, participants with any prior or concurrent skin malignancies will be excluded
- Sub-study: Participants must have new-onset or persistent (defined as non-responsive to standard of care [SoC]) Grade >=2 specific DAEIs of the scalp, face, or body, as defined by NCI-CTCAE Grading v5.0 for DAEIs (excluding paronychia)
Exclusion Criteria:
- History of uncontrolled illness, including but not limited to uncontrolled diabetes; ongoing or active infection (includes infection requiring treatment with antimicrobial therapy [participants will be required to complete antibiotics 1 week prior to starting background anticancer treatment] or diagnosed or suspected viral infection). For the amivantamab SC expansion cohorts, this includes active localized serious infections; active bleeding diathesis; impaired oxygenation requiring continuous oxygen supplementation; refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of background anticancer treatment or doxycycline/minocycline; psychiatric illness, social situation, or any other circumstances that would limit compliance with study requirements; any ophthalmologic condition that is clinically unstable; pre-existing skin condition that would prevent adequate evaluations of dermatologic toxicity, as determined by the investigator
- Medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
- Known allergy, hypersensitivity, or intolerance to the excipients of amivantamab, lazertinib, or to tetracyclines, doxycycline, minocycline, timolol*, ruxolitinib*, zinc*, corticosteroids* or their excipients or to any component of the enhanced dermatologic management (*for the amivantamab SC expansion cohorts)
- Participant has received any prior systemic treatment at any time for locally advanced stage III B/C or metastatic stage IV disease (adjuvant or neoadjuvant therapy for stage I, II or IIIA disease is allowed if last dose administered more than 12 months prior to the development of locally advanced or metastatic disease)
- Participant has an active or past medical history of leptomeningeal disease
- Sub-study: Participants who have received prior treatment for epidermal growth factor receptor (EGFR)-induced DAEIs with JAK inhibitors (for Cohort A) or calcineurin inhibitors (for Cohort B)
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Arm A: Enhanced Dermatologic Management
Participants will receive enhanced dermatologic management to reduce toxicities in skin and nail with doxycycline tablet or minocycline capsule, clindamycin topical lotion, chlorhexidine topical solution, and noncomedogenic skin moisturizer during background anticancer treatment of advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) with amivantamab intravenously (Dose 1 for body weight [BW] less than 80 kilograms [kg] and Dose 2 for BW greater than or equal to [>=] 80 kg as IV infusion [Arm A]) until documented disease progression using Response Evaluation Criteria in Solid Tumors version 1.1). |
Amivantamab will be administered.
Другие имена:
Lazertinib tablet will be administered orally.
Другие имена:
Doxycycline tablet will be administered orally. Minocycline capsule will be administered orally. Clindamycin lotion will be used as topical application on the scalp. Chlorhexidine solution will be used as topical application on hands and feet. Noncomedogenic skin moisturizer will be used as topical application. |
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Активный компаратор: Arm B: Standard-of-Care Dermatologic Management
Participants will receive standard care for dermatologic management according to local practice to reduce dermatologic toxicities in skin and nail during background anticancer treatment of advanced or metastatic EGFR-mutated NSCLC with amivantamab administered as IV infusion plus lazertinib, dose and dosing schedule as same as experimental arm. |
Amivantamab will be administered.
Другие имена:
Lazertinib tablet will be administered orally.
Другие имена:
Chlorhexidine solution will be used as topical application on hands and feet. Noncomedogenic skin moisturizer will be used as topical application. |
|
Экспериментальный: Sub-study: Cohort A: Ruxolitinib
Participants enrolled in Arms A and B of the main study who experience new-onset or persistent specific DAEIs (Grade greater than or equal to [>=] 2, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] v5.0) will be enrolled and receive reactive treatment with ruxolitinib in the sub-study. Participants in the sub-study will continue to receive amivantamab and lazertinib. |
Amivantamab will be administered.
Другие имена:
Lazertinib tablet will be administered orally.
Другие имена:
Doxycycline tablet will be administered orally. Minocycline capsule will be administered orally. Clindamycin lotion will be used as topical application on the scalp. Chlorhexidine solution will be used as topical application on hands and feet. Noncomedogenic skin moisturizer will be used as topical application. Ruxolitinib will be used to the affected skin area. |
|
Экспериментальный: Sub-study: Cohort B: Tacrolimus
Participants enrolled in Arms A and B of the main study who experience new-onset or persistent specific DAEIs (Grade >= 2, as defined by NCI-CTCAE v5.0) will be enrolled and receive reactive treatment with tacrolimus in the sub-study. Participants in the sub-study will continue to receive amivantamab and lazertinib. |
Amivantamab will be administered.
Другие имена:
Lazertinib tablet will be administered orally.
Другие имена:
Doxycycline tablet will be administered orally. Minocycline capsule will be administered orally. Clindamycin lotion will be used as topical application on the scalp. Chlorhexidine solution will be used as topical application on hands and feet. Noncomedogenic skin moisturizer will be used as topical application. Tacrolimus will be used as topical application to the affected skin area. |
|
Экспериментальный: Amivantamab Subcutaneous (SC) Expansion Cohort: Standard Schedule
Participants will receive modified enhanced dermatologic management with oral doxycycline or minocycline, zinc gluconate and noncomedogenic skin moisturizer during background anticancer treatment of advanced or metastatic EGFR mutated NSCLC with amivantamab SC and lazertinib as per standard schedule. If a participant develops a dermatologic adverse event of interest (DAEI) they will receive early intervention as follows: for facial (ruxolitinib), for scalp (oral propranolol and clobetasol), for paronychia (chlorhexidine in addition to timolol) until documented disease progression using Response Evaluation Criteria in Solid Tumors version 1.1. |
Lazertinib tablet will be administered orally.
Другие имена:
Doxycycline tablet will be administered orally. Minocycline capsule will be administered orally. Chlorhexidine solution will be used as topical application on hands and feet. Noncomedogenic skin moisturizer will be used as topical application. Ruxolitinib will be used to the affected skin area. Amivantamab will be administered as SC injection.
Другие имена:
Zinc gluconate tablet will be administered. Propranolol tablet will be administered. Timolol will be used to the affected skin area. Clobetasol shampoo will be used on the scalp. |
|
Экспериментальный: Amivantamab SC Expansion Cohort: Modified Schedule
Participants will receive modified enhanced dermatologic management with oral doxycycline or minocycline, zinc gluconate and noncomedogenic skin moisturizer during background anticancer treatment of advanced or metastatic EGFR mutated NSCLC with amivantamab SC and lazertinib as per modified schedule. If a participant develops a DAEI they will receive early intervention as follows: for facial (ruxolitinib), for scalp (oral propranolol and clobetasol), for paronychia (chlorhexidine in addition to timolol) until documented disease progression using Response Evaluation Criteria in Solid Tumors version 1.1. |
Lazertinib tablet will be administered orally.
Другие имена:
Doxycycline tablet will be administered orally. Minocycline capsule will be administered orally. Amivantamab will be administered as SC injection.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Number of Participants With Grade Greater Than or Equal to (>=) 2 Dermatologic Adverse Events of Interest (DAEIs) Within 12 Weeks After Initiation of Anticancer Treatment
Временное ограничение: Up to 12 weeks after initiation of anticancer treatment
|
Number of participants with Grade >= 2 DAEIs within 12 weeks after initiation of anticancer treatment based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version (v) 5.0 will be reported. DAEIs includes rash, dermatitis acneiform, pruritus, skin fissures, acne, folliculitis, erythema, eczema, rash maculo-papular, skin exfoliation, skin lesion, skin irritation, dermatitis, rash erythematous, rash macular, rash popular, rash pruritic, rash pustular, dermatitis contact, dermatitis exfoliative generalized, drug eruption, dyshidrotic eczema, eczema asteatotic and paronychia. As per NCI CTCAE v 5.0, severity scale ranges from Grade 1 (mild) to Grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, and Grade 5= death related to adverse event. |
Up to 12 weeks after initiation of anticancer treatment
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Number of Participants With DAEIs by Severity Based on NCI-CTCAE v 5.0
Временное ограничение: Up to 12 weeks after initiation of anticancer treatment
|
Number of participants with DAEIs by severity based on NCI-CTCAE v 5.0 will be reported. |
Up to 12 weeks after initiation of anticancer treatment
|
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Number of Participants With Grade >=2 DAEIs Within 6 Months After Initiation of Anticancer Treatment Based on NCI-CTCAE v 5.0
Временное ограничение: Up to 6 months after initiation of anticancer treatment
|
Number of participants with Grade >=2 DAEIs within 6 months after initiation of anticancer treatment based on NCI-CTCAE v 5.0 will be reported. |
Up to 6 months after initiation of anticancer treatment
|
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Number of Grade >= 2 DAEI Per Participants
Временное ограничение: Up to 12 months
|
Number of grade >= 2 DAEI per participants will be reported. |
Up to 12 months
|
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Time to First Occurrence of Grade >=2 DAEI
Временное ограничение: Up to 12 months
|
Time to first occurrence of Grade >=2 DAEI will be reported. |
Up to 12 months
|
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Time to Resolution of Grade >= 2 DAEI
Временное ограничение: Up to 12 months
|
Time to resolution of Grade >= 2 DAEI will be reported. |
Up to 12 months
|
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Number of Participants With Paronychia by Severity Based on NCI-CTCAE v 5.0
Временное ограничение: Up to 6 months after initiation of anticancer treatment
|
Number of participants with paronychia by severity based on NCI-CTCAE v 5.0 will be reported. |
Up to 6 months after initiation of anticancer treatment
|
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Number of Participants With Scalp Rash by Severity Based on NCI-CTCAE v 5.0
Временное ограничение: Up to 12 months after initiation of anticancer treatment
|
Number of participants with scalp rash by severity based on NCI-CTCAE v 5.0 will be reported. |
Up to 12 months after initiation of anticancer treatment
|
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Change From Baseline in Skindex Symptoms Domain Score up to 12 Months
Временное ограничение: Baseline, up to Month 12
|
Change from baseline in skindex symptoms domain score up to 12 months will be reported. The score of quality of life will be assessed using the Skindex-16 questionnaire. Skindex-16 is used for participants to rate skin conditions. |
Baseline, up to Month 12
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Change From Baseline in Patient's Global Impression-Severity (PGI-S) Rash up to 12 Months
Временное ограничение: Baseline, up to Month 12
|
Change from baseline in PGI-S rash up to 12 months will be reported. Participant quality of life will be evaluated using PGI-S Rash. PGI-S is a single-item questionnaire assessing participants disease severity on a 7-point response scale. |
Baseline, up to Month 12
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Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Score up to 12 Months
Временное ограничение: Baseline, up to Month 12
|
Change from baseline in EORTC-QLQ-C30 score up to 12 months will be reported. EORTC-QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. |
Baseline, up to Month 12
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Change From Baseline in EuroQol 5 - Dimension (EQ-5D) Patient-reported Outcome (PRO) up to 12 Months (for Amivantamab Subcutaneous Expansion Cohort Only)
Временное ограничение: Baseline, up to Month 12
|
The EQ-5D questionnaire is a brief, generic HRQOL assessment that can that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. EQ-5D scores include EQ-5D valuation index score (a weighted scoring of the 5 dimension scores with a possible range from 0 to 1), EQ-5D visual analog scale (VAS) is a vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health), and EQ5D descriptive system scores (five scores reflecting each of the 5 EQ-5D health dimensions ranging from 0 [no limitation] to 4 [incapacity]). |
Baseline, up to Month 12
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Percentage of Participants With Dose Reductions, Dose Interruptions, and Dose Discontinuations of Anticancer Treatment due to DAEIs
Временное ограничение: Up to 12 months
|
Percentage of participants with dose reductions, dose interruptions, and dose discontinuations of anticancer treatment due to DAEIs will be reported. |
Up to 12 months
|
|
Relative Dose Intensity (RDI) of Anticancer Treatment
Временное ограничение: Up to 12 months
|
Relative dose intensity of anticancer treatment will be reported. The relative dose intensity is defined as the ratio of total actually received dose versus total prescribed dose. |
Up to 12 months
|
|
Percentage of Participants With Venous Thromboembolism (VTE) Adverse Events (AEs) by Severity Based on NCI-CTCAE v 5.0
Временное ограничение: Up to 12 months
|
Percentage of participants with VTE AEs (pulmonary embolism and deep vein thrombosis) by severity based on NCI-CTCAE v 5.0 will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. |
Up to 12 months
|
|
Percentage of Participants With Adverse Events (AEs) by Severity Based on NCI-CTCAE v 5.0
Временное ограничение: Up to 12 months
|
Percentage of participants with AEs by severity based on NCI-CTCAE v 5.0 will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. |
Up to 12 months
|
|
Progression Free Survival (PFS)
Временное ограничение: Up to 12 months
|
PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death due to any cause, whichever occurs first. |
Up to 12 months
|
|
Overall Response Rate (ORR)
Временное ограничение: Up to 12 months
|
ORR is defined as the percentage of participants who achieve a partial response (PR) or better response using RECIST v1.1 as assessed by the investigator. |
Up to 12 months
|
|
Duration of Response (DoR)
Временное ограничение: Up to 12 months
|
DOR will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the RECIST v1.1 response criteria. |
Up to 12 months
|
|
Amivantamab SC Expansion Cohorts: Number of Participants With Grade >= 2 DAEIs Within 12 Weeks After Initiation of Anticancer Treatment
Временное ограничение: Up to 12 weeks after initiation of anticancer treatment
|
Participants with Grade >= 2 DAEIs within 12 weeks after initiation of anticancer treatment based on NCI-CTCAE v 5.0 will be reported. DAEIs includes rash, dermatitis acneiform, pruritus, skin fissures, acne, folliculitis, erythema, eczema, rash maculo-papular, skin exfoliation, skin lesion, skin irritation, dermatitis, rash erythematous, rash macular, rash popular, rash pruritic, rash pustular, dermatitis contact, dermatitis exfoliative generalized, drug eruption, dyshidrotic eczema, eczema asteatotic and paronychia. As per NCI-CTCAE v 5.0, severity scale ranges from Grade 1 (mild) to Grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, and Grade 5= death related to adverse event. |
Up to 12 weeks after initiation of anticancer treatment
|
|
Amivantamab SC Expansion Cohorts: Percentage of Participants With an Improvement in DAEI After Starting Early Intervention
Временное ограничение: Up to 12 months
|
Percentage of participants showing an improvement in DAEI by a minimum of 1 NCI-CTCAE grade after starting early intervention will be reported. As per NCI-CTCAE v 5.0, severity scale ranges from Grade 1 (mild) to Grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, and Grade 5= death related to adverse event. |
Up to 12 months
|
|
Amivantamab SC Expansion Cohorts: Time to Improvement of DAEIs After Starting Early Intervention
Временное ограничение: Up to 12 months
|
Time to improvement of DAEIs by a minimum of 1 NCI-CTCAE grade after starting early intervention will be reported. As per NCI-CTCAE v 5.0, severity scale ranges from Grade 1 (mild) to Grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, and Grade 5= death related to adverse event. |
Up to 12 months
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percentage of Participants Achieving Best Response for the Dermatologic Adverse Event
Временное ограничение: Up to 12 weeks
|
Participants achieving best response within 12 weeks of treatment defined as NCI-CTCAE level of the dermatologic adverse event improvement by at least 1 level will be reported. |
Up to 12 weeks
|
Соавторы и исследователи
Следователи
- Директор по исследованиям: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Публикации и полезные ссылки
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
- Новообразования по локализации
- Новообразования
- Заболевания дыхательных путей
- Легочные заболевания
- Новообразования дыхательных путей
- Грудные новообразования
- Новообразования легких
- Рак, Бронхогенный
- Бронхиальные новообразования
- Карцинома немелкоклеточного легкого
- Средние соединения
- Органические химические вещества
- Гетероциклические соединения, 1-кольцо
- Гетероциклические соединения
- Тиазолы
- Азолы
- Углеводороды
- Углеводороды, циклические
- Углеводы
- Нафталины
- Полициклические ароматические углеводороды
- Углеводороды, ароматные
- Полициклические соединения
- Гликозиды
- Амины
- Стероиды
- Соединения слитого кольца
- Стероиды, фторированные
- Спирты
- Макролиды
- Лактоны
- Нафтацены
- Феноксипропаноламины
- Пропаноламины
- Амино -спирты
- Пропанолы
- Пирролидины
- Тетрациклины
- Линкомицин
- Линкосамиды
- Бигуаниды
- Гуанидины
- Амидины
- Тиадиазолы
- Морфолины
- Оксазины
- Бетаметазон
- Миноциклин
- Доксициклин
- Такролимус
- Хлоргексидин
- Клиндамицин
- Тимолол
- Пропранолол
- Клобетазол
- Амивантамаб
- Лазертиниб
- Руксолитиниб
- глюконовая кислота
Другие идентификационные номера исследования
- 61186372NSC2007
- 61186372NSC2007 (Другой идентификатор: Janssen Research & Development, LLC)
- 2023-505863-35-00 (Идентификатор реестра: EUCT number)
- 2023 (Грант/контракт NIH США)
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.
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