Verbeterde dermatologische zorg om huiduitslag en paronychia te verminderen bij epidermale groeifactorreceptor (EGRF)-gemuteerde niet-kleincellige longkanker (NSCLC), eerstelijns behandeld met Amivantamab plus Lazertinib (COCOON)
Een fase 2, open-label, gerandomiseerde studie ter evaluatie van de impact van verbeterde versus standaard dermatologische behandeling op geselecteerde dermatologische bijwerkingen bij patiënten met lokaal gevorderd of gemetastaseerd EGFR-gemuteerd NSCLC, eerstelijns behandeld met Amivantamab + Lazertinib
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
- Geneesmiddel: Amivantamab IV
- Geneesmiddel: Lazertinib
- Geneesmiddel: Doxycycline
- Geneesmiddel: Minocycline
- Geneesmiddel: Clindamycin
- Geneesmiddel: Chlorhexidine
- Ander: Noncomedogenic skin moisturizer
- Ander: Ruxolitinib
- Ander: Tacrolimus
- Geneesmiddel: Amivantamab SC
- Geneesmiddel: Zinc gluconate
- Geneesmiddel: Propranolol
- Geneesmiddel: Timolol
- Geneesmiddel: Clobetasol
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Buenos Aires, Argentinië, C1199
- Hospital Italiano de Buenos Aires
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CABA, Argentinië, C1122
- IADT Instituto Argentino de Diagnostico y Tratamiento
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Capital Federal, Argentinië, C1017
- Centro Medico Austral
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La Plata, Argentinië, B1900AXI
- Hospital Italiano de La Plata
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Mar del Plata, Argentinië, B7602
- Hospital Privado de la Comunidad
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Belo Horizonte, Brazilië, 30150-221
- Santa Casa de Misericordia de Belo Horizonte
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Belém, Brazilië, 66.073-005
- CTO Centro De Tratamento Oncologico LTDA
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Curitiba, Brazilië, 81520-060
- Liga Paranaense de Combate ao Cancer
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Jaú, Brazilië, 17.210-080
- Fundacao Doutor Amaral Carvalho
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Porto Alegre, Brazilië, 91350 200
- Hospital Nossa Senhora da Conceicao S A
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Salvador, Brazilië, 40170 070
- Nucleo de Oncologia da Bahia Oncoclinicas
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Santa Cruz do Sul, Brazilië, 96835-100
- Hospital Ana Nery Santa Cruz do Sul
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São Paulo, Brazilië, 01509 900
- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, Brazilië, 01246 000
- Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
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Taubaté, Brazilië, 12030-200
- Servicos de Tratamento ao Cancer de Taubate LTDA - Instituto do Cancer Brasil Unidade Taubate
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Vitória, Brazilië, 29043-260
- Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
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Changzhou, China, 213004
- Changzhou No 2 Peoples Hospital
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Chengdoucun, China, 610041
- West China Hospital
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Chengdu, China, 610041
- Sichuan Cancer Hospital
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Guangzhou, China, 510080
- The First Affiliated Hospital Sun Yat sen University
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Hangzhou, China, 310003
- The First Affiliated Hospital Zhejiang University School of Medicine
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Harbin, China, 150040
- Harbin medical university cancer hospital
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Huizhou, China, 516001
- Huizhou Municipal Central Hospital
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Nanjing, China, 210000
- Zhongda Hospital Southeast University
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Shanghai, China, 200032
- Fudan University Shanghai Cancer Center
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Xi'an, China, 710061
- The First Affiliated Hospital of Xian Jiaotong University
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Zhengzhou, China, 450008
- Henan Cancer Hospital
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Aachen, Duitsland, 52074
- Universitaetsklinikum der RWTH Aachen
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Essen, Duitsland, 45136
- Kliniken Essen-Mitte
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Giessen, Duitsland, 35392
- Universitaetsklinikum Giessen und Marburg GmbH
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Heidelberg, Duitsland, 69126
- Thoraxklinik am Universitatsklinikum Heidelberg
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Kassel, Duitsland, 34125
- Klinikum Kassel GmbH
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Kiel, Duitsland, 24105
- Universitaetsklinikum Schleswig Holstein Campus Kiel
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Marseille, Frankrijk, 13915
- Hopital Nord
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Nice, Frankrijk, 06001
- Hopital PASTEUR
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Paris, Frankrijk, 75005
- Institut Curie
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George Town, Maleisië, 10450
- Hospital Pulau Pinang
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Kuala Lumpur, Maleisië, 59100
- University Malaya Medical Centre
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Kuantan, Maleisië, 25100
- Hospital Tengku Ampuan Afzan
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Kuching, Maleisië, 93586
- Hospital Umum Sarawak
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A Coruña, Spanje, 15006
- Hosp Univ A Coruna
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Alicante, Spanje, 03010
- Hosp. Gral. Univ. de Alicante
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Barcelona, Spanje, 08028
- Hosp. Univ. Quiron Dexeus
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Barcelona, Spanje, 08035
- Hosp Univ Vall D Hebron
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Jaén, Spanje, 23007
- Hosp. Univ. de Jaen
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Lugo, Spanje, 27003
- Hosp. Univ. Lucus Augusti
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Madrid, Spanje, 28007
- Hosp. Gral. Univ. Gregorio Maranon
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Málaga, Spanje, 29010
- Hosp Regional Univ de Malaga
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Seville, Spanje, 41014
- Hosp. Ntra. Sra. de Valme
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Hsinchu, Taiwan, 30059
- National Taiwan University Hospital Hsin Chu Branch
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Kaohsiung City, Taiwan, 833
- Chang Gung Memorial Hospital
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Taichung, Taiwan, 40705
- Taichung Veterans General Hospital
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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Taoyuan City, Taiwan, 333
- Linkou Chang Gung Memorial Hospital
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Adana, Turkije (Türkiye), 1060
- Adana City Hospital
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Ankara, Turkije (Türkiye), 06560
- Gazi University Hospital
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Ankara, Turkije (Türkiye), 06010
- Gulhane Training and Research Hospital
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Ankara, Turkije (Türkiye), 6800
- Ankara Bilkent City Hospital
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Istanbul, Turkije (Türkiye), 34147
- Bakirkoy Training and Research Hospital
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Istanbul, Turkije (Türkiye), 34295
- I A U VM Medical Park Florya Hastanesi
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Izmir, Turkije (Türkiye), 35100
- Ege University Medical Faculty
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Samsun, Turkije (Türkiye), 55420
- Ondokuz Mayis University
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Arizona
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Chandler, Arizona, Verenigde Staten, 85224
- Ironwood Cancer and Research Center
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California
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Duarte, California, Verenigde Staten, 91010
- City of Hope
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Fullerton, California, Verenigde Staten, 92835
- Providence Fullerton
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Glendale, California, Verenigde Staten, 91204
- Los Angeles Cancer Network
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Huntington Beach, California, Verenigde Staten, 92648
- City of Hope Seacliff
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Irvine, California, Verenigde Staten, 92618
- City of Hope Orange County Lennar Foundation Cancer Center
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Long Beach, California, Verenigde Staten, 90813
- City of Hope Long Beach Elm
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Los Alamitos, California, Verenigde Staten, 90720
- Cancer and Blood Specialty Clinic
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Los Angeles, California, Verenigde Staten, 90033
- Keck Hospital of USC
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Newport Beach, California, Verenigde Staten, 92663
- USC Norris Oncology Hematology Newport Beach
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Oakland, California, Verenigde Staten, 94611
- Kaiser Permanente Oakland Medical Center
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Roseville, California, Verenigde Staten, 95661
- Kaiser Permanente Roseville Medical Center
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San Francisco, California, Verenigde Staten, 94115
- Kaiser Permanente San Francisco Medical Center
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Santa Clara, California, Verenigde Staten, 95051
- Kaiser Permanente Santa Clara Medical Center
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South Pasadena, California, Verenigde Staten, 91030
- City of Hope South Pasadena
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Vallejo, California, Verenigde Staten, 94589
- Kaiser Permanente Northern California
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Walnut Creek, California, Verenigde Staten, 94596
- Kaiser Permanente Walnut Creek Medical Center
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Georgia
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Athens, Georgia, Verenigde Staten, 30607
- University Cancer & Blood Center
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Illinois
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Hinsdale, Illinois, Verenigde Staten, 60521
- Hope and Healing Care
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Missouri
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Springfield, Missouri, Verenigde Staten, 65807
- Oncology Hematology Associates
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Nevada
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Reno, Nevada, Verenigde Staten, 89502
- Renown Health Medical Oncology
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New Jersey
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Flemington, New Jersey, Verenigde Staten, 08822
- Hunterdon Hematology Oncology
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New York
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Westbury, New York, Verenigde Staten, 11590
- Clinical Research Alliance Inc
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North Carolina
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Wilson, North Carolina, Verenigde Staten, 27893
- Regional Medical Oncology Center
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Ohio
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Cleveland, Ohio, Verenigde Staten, 44106
- University Hospitals Cleveland Medical Center
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Virginia
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Fairfax, Virginia, Verenigde Staten, 22031
- Virginia Cancer Specialists
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Washington
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Renton, Washington, Verenigde Staten, 98055
- Valley Medical Center
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Wisconsin
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West Salem, Wisconsin, Verenigde Staten, 54669
- Gundersen Health System
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Cheongju-si, Zuid -Korea, 28644
- Chungbuk National University Hospital
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Incheon, Zuid -Korea, 21565
- Gachon University Gil Medical Center
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Seoul, Zuid -Korea, 03722
- Severance Hospital Yonsei University Health System
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
Andere namen:
Lazertinib tablet will be administered orally.
Andere namen:
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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Actieve vergelijker: 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.
Andere namen:
Lazertinib tablet will be administered orally.
Andere namen:
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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Experimenteel: 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.
Andere namen:
Lazertinib tablet will be administered orally.
Andere namen:
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. |
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Experimenteel: 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.
Andere namen:
Lazertinib tablet will be administered orally.
Andere namen:
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. |
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Experimenteel: 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.
Andere namen:
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.
Andere namen:
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. |
|
Experimenteel: 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.
Andere namen:
Doxycycline tablet will be administered orally. Minocycline capsule will be administered orally. Amivantamab will be administered as SC injection.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of Participants With DAEIs by Severity Based on NCI-CTCAE v 5.0
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
|
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Relative Dose Intensity (RDI) of Anticancer Treatment
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
|
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Overall Response Rate (ORR)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percentage of Participants Achieving Best Response for the Dermatologic Adverse Event
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Onderzoekers
- Studie directeur: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per site
- Neoplasmata
- Ziekten van de luchtwegen
- Longziekten
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Longneoplasmata
- Carcinoom, bronchogeen
- Bronchiale neoplasmata
- Carcinoom, niet-kleincellige long
- Zwavelverbindingen
- Organische chemicaliën
- Heterocyclische verbindingen, 1-ring
- Heterocyclische verbindingen
- Thiazoles
- Azoles
- Koolwaterstoffen
- Koolwaterstoffen, cyclisch
- Koolhydraten
- Naftalenen
- Polycyclische aromatische koolwaterstoffen
- Koolwaterstoffen, aromatisch
- Polycyclische verbindingen
- Glycosiden
- Amines
- Steroïden
- Verbindingen met gefuseerde ring
- Steroïden, gefluoreerd
- Alcohol
- Macrolides
- Lactonen
- Naftacenes
- Fenoxypropanolamines
- Propanolamines
- Aminoalcoholen
- Propanolen
- Pyrrolidines
- Tetracyclines
- Lincomycine
- Lincosamides
- Biguanides
- Guanidines
- Amidines
- Thiadiazoles
- Morfolines
- Oxazines
- Betamethason
- Minocycline
- Doxycycline
- Tacrolimus
- Chloorhexidine
- Clindamycine
- Timolol
- Propranolol
- Clobetasol
- Amivantamab
- lazertinib
- ruxolitinib
- gluconzuur
Andere studie-ID-nummers
- 61186372NSC2007
- 61186372NSC2007 (Andere identificatie: Janssen Research & Development, LLC)
- 2023-505863-35-00 (Register-ID: EUCT number)
- 2023 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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