Trial Title:
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib
NCT ID:
NCT06120140
Condition:
Carcinoma, Non-Small-Cell Lung
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Chlorhexidine
Doxycycline
Minocycline
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Amivantamab-vmjw
Lazertinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Amivantamab
Description:
Amivantamab will be administered as intravenous (IV) infusion or SC injection.
Arm group label:
Arm A and Subcutaneous (SC) Expansion Cohort: Enhanced Dermatologic Management
Arm group label:
Arm B: Standard-of-Care Dermatologic Management
Other name:
JNJ-61186372
Intervention type:
Drug
Intervention name:
Lazertinib
Description:
Lazertinib tablet will be administered orally.
Arm group label:
Arm A and Subcutaneous (SC) Expansion Cohort: Enhanced Dermatologic Management
Arm group label:
Arm B: Standard-of-Care Dermatologic Management
Other name:
JNJ-73841937
Intervention type:
Drug
Intervention name:
Doxycycline
Description:
Doxycycline tablet will be administered orally.
Arm group label:
Arm A and Subcutaneous (SC) Expansion Cohort: Enhanced Dermatologic Management
Intervention type:
Drug
Intervention name:
Minocycline
Description:
Minocycline capsule will be administered orally.
Arm group label:
Arm A and Subcutaneous (SC) Expansion Cohort: Enhanced Dermatologic Management
Intervention type:
Drug
Intervention name:
Clindamycin
Description:
Clindamycin lotion will be used as topical application on the scalp.
Arm group label:
Arm A and Subcutaneous (SC) Expansion Cohort: Enhanced Dermatologic Management
Intervention type:
Drug
Intervention name:
Chlorhexidine
Description:
Chlorhexidine solution will be used as topical application on hands and feet.
Arm group label:
Arm A and Subcutaneous (SC) Expansion Cohort: Enhanced Dermatologic Management
Intervention type:
Other
Intervention name:
Noncomedogenic skin moisturizer
Description:
Noncomedogenic skin moisturizer will be used as topical application.
Arm group label:
Arm A and Subcutaneous (SC) Expansion Cohort: Enhanced Dermatologic Management
Summary:
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 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.
Criteria for eligibility:
Criteria:
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)
- Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
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); 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, or their excipients or to
any component of the enhanced dermatologic management
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ironwood Cancer and Research Center
Address:
City:
Chandler
Zip:
85224
Country:
United States
Status:
Recruiting
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
Providence Fullerton
Address:
City:
Fullerton
Zip:
92835
Country:
United States
Status:
Recruiting
Facility:
Name:
Los Angeles Cancer Network
Address:
City:
Glendale
Zip:
91204
Country:
United States
Status:
Recruiting
Facility:
Name:
City of Hope Seacliff
Address:
City:
Huntington Beach
Zip:
92648
Country:
United States
Status:
Recruiting
Facility:
Name:
City of Hope Orange County Lennar Foundation Cancer Center
Address:
City:
Irvine
Zip:
92618
Country:
United States
Status:
Recruiting
Facility:
Name:
City of Hope Long Beach Elm
Address:
City:
Long Beach
Zip:
90813
Country:
United States
Status:
Recruiting
Facility:
Name:
Cancer and Blood Specialty Clinic
Address:
City:
Los Alamitos
Zip:
90720
Country:
United States
Status:
Recruiting
Facility:
Name:
Keck Hospital of USC
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Facility:
Name:
USC Norris Oncology Hematology Newport Beach
Address:
City:
Newport Beach
Zip:
92663
Country:
United States
Status:
Recruiting
Facility:
Name:
Kaiser Permanente Oakland Medical Center
Address:
City:
Oakland
Zip:
94611
Country:
United States
Status:
Recruiting
Facility:
Name:
Kaiser Permanente Roseville Medical Center
Address:
City:
Roseville
Zip:
95661
Country:
United States
Status:
Recruiting
Facility:
Name:
Kaiser Permanente San Francisco Medical Center
Address:
City:
San Francisco
Zip:
94115
Country:
United States
Status:
Recruiting
Facility:
Name:
Kaiser Permanente Santa Clara Medical Center
Address:
City:
Santa Clara
Zip:
95051
Country:
United States
Status:
Recruiting
Facility:
Name:
City of Hope South Pasadena
Address:
City:
South Pasadena
Zip:
91030
Country:
United States
Status:
Recruiting
Facility:
Name:
Kaiser Permanente Northern California
Address:
City:
Vallejo
Zip:
94589
Country:
United States
Status:
Recruiting
Facility:
Name:
Kaiser Permanente Walnut Creek Medical Center
Address:
City:
Walnut Creek
Zip:
94596
Country:
United States
Status:
Recruiting
Facility:
Name:
University Cancer & Blood Center
Address:
City:
Athens
Zip:
30607
Country:
United States
Status:
Recruiting
Facility:
Name:
Hope and Healing Care
Address:
City:
Hinsdale
Zip:
60521
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology Hematology Associates
Address:
City:
Springfield
Zip:
65807
Country:
United States
Status:
Recruiting
Facility:
Name:
Renown Health Medical Oncology
Address:
City:
Reno
Zip:
89502
Country:
United States
Status:
Recruiting
Facility:
Name:
Hunterdon Hematology Oncology
Address:
City:
Flemington
Zip:
08822
Country:
United States
Status:
Recruiting
Facility:
Name:
Clinical Research Alliance Inc
Address:
City:
Westbury
Zip:
11590
Country:
United States
Status:
Recruiting
Facility:
Name:
Regional Medical Oncology Center
Address:
City:
Wilson
Zip:
27893
Country:
United States
Status:
Recruiting
Facility:
Name:
University Hospitals Cleveland Medical Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Valley Medical Center
Address:
City:
Renton
Zip:
98055
Country:
United States
Status:
Recruiting
Facility:
Name:
Gundersen Health System
Address:
City:
W. Salem
Zip:
54669
Country:
United States
Status:
Recruiting
Facility:
Name:
Hospital Italiano de Buenos Aires
Address:
City:
Buenos Aires
Zip:
C1199
Country:
Argentina
Status:
Recruiting
Facility:
Name:
IADT Instituto Argentino de Diagnostico y Tratamiento
Address:
City:
Caba
Zip:
C1122
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Centro Medico Austral
Address:
City:
Capital Federal
Zip:
C1017
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Hospital Italiano de La Plata
Address:
City:
La Plata
Zip:
B1900AXI
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Hospital Privado de la Comunidad
Address:
City:
Mar del Plata
Zip:
B7602
Country:
Argentina
Status:
Recruiting
Facility:
Name:
CTO Centro De Tratamento Oncologico LTDA
Address:
City:
Belem
Zip:
66.073-005
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Santa Casa de Misericordia de Belo Horizonte
Address:
City:
Belo Horizonte
Zip:
30150-221
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Liga Paranaense de Combate ao Cancer
Address:
City:
Curitiba
Zip:
81520-060
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Fundacao Doutor Amaral Carvalho
Address:
City:
Jaú
Zip:
17.210-080
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Nossa Senhora da Conceicao S A
Address:
City:
Porto Alegre
Zip:
91350 200
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Nucleo de Oncologia da Bahia Oncoclinicas
Address:
City:
Salvador
Zip:
40170 070
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Ana Nery Santa Cruz do Sul
Address:
City:
Santa Cruz do Sul
Zip:
96835-100
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
Address:
City:
Sao Paulo
Zip:
01246 000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Fundacao Antonio Prudente A C Camargo Cancer Center
Address:
City:
Sao Paulo
Zip:
01509 900
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Servicos de Tratamento ao Cancer de Taubate LTDA - Instituto do Cancer Brasil Unidade Taubate
Address:
City:
Taubate
Zip:
12030-200
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
Address:
City:
Vitoria
Zip:
29043-260
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Changzhou No 2 Peoples Hospital
Address:
City:
Changzhou
Zip:
213004
Country:
China
Status:
Recruiting
Facility:
Name:
West China Hospital
Address:
City:
Chengdou
Zip:
610041
Country:
China
Status:
Recruiting
Facility:
Name:
Sichuan Cancer Hospital
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital Sun Yat sen University
Address:
City:
Guang Zhou
Zip:
510080
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital Zhejiang University College of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Facility:
Name:
Harbin medical university cancer hospital
Address:
City:
Harbin
Zip:
150040
Country:
China
Status:
Recruiting
Facility:
Name:
Huizhou Municipal Central Hospital
Address:
City:
Huizhou
Zip:
516001
Country:
China
Status:
Recruiting
Facility:
Name:
Zhongda Hospital Southeast University
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Recruiting
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
ShangHai
Zip:
200032
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Xian Jiaotong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Status:
Recruiting
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Status:
Recruiting
Facility:
Name:
Hopital Nord
Address:
City:
Marseille Cedex 20
Zip:
13915
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital PASTEUR
Address:
City:
Nice
Zip:
06001
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Curie
Address:
City:
Paris
Zip:
75005
Country:
France
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum der RWTH Aachen
Address:
City:
Aachen
Zip:
52074
Country:
Germany
Status:
Recruiting
Facility:
Name:
Kliniken Essen-Mitte
Address:
City:
Essen
Zip:
45136
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Giessen und Marburg GmbH
Address:
City:
Giessen
Zip:
35392
Country:
Germany
Status:
Recruiting
Facility:
Name:
Thoraxklinik am Universitatsklinikum Heidelberg
Address:
City:
Heidelberg
Zip:
69126
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinikum Kassel GmbH
Address:
City:
Kassel
Zip:
34125
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Schleswig Holstein Campus Kiel
Address:
City:
Kiel
Zip:
24105
Country:
Germany
Status:
Recruiting
Facility:
Name:
Chungbuk National University Hospital
Address:
City:
Cheongju-si
Zip:
28644
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Gachon University Gil Hospital
Address:
City:
Incheon
Zip:
405-760
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Hospital Pulau Pinang
Address:
City:
Georgetown
Zip:
10450
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
University Malaya Medical Centre
Address:
City:
Kuala Lumpur
Zip:
59100
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Hospital Tengku Ampuan Afzan
Address:
City:
Kuantan
Zip:
25100
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Hospital Umum Sarawak
Address:
City:
Kuching
Zip:
93586
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Hosp Univ A Coruna
Address:
City:
A Coruna
Zip:
15006
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Gral. Univ. de Alicante
Address:
City:
Alicante
Zip:
03010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Univ. Quiron Dexeus
Address:
City:
Barcelona
Zip:
08028
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp Univ Vall D Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Univ. de Jaen
Address:
City:
Jaen
Zip:
23007
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Univ. Lucus Augusti
Address:
City:
Lugo
Zip:
27003
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Gral. Univ. Gregorio Maranon
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp Regional Univ de Malaga
Address:
City:
Malaga
Zip:
29010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Ntra. Sra. de Valme
Address:
City:
Sevilla
Zip:
41014
Country:
Spain
Status:
Recruiting
Facility:
Name:
National Taiwan University Hospital Hsin Chu Branch
Address:
City:
Hsin Chu
Zip:
30059
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Chang Kung Memorial Hospital
Address:
City:
Kaohsiung City
Zip:
833
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taichung Veterans General Hospital
Address:
City:
Taichung City
Zip:
40705
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Linkou Chang Gung Memorial Hospital
Address:
City:
Taoyuan City
Zip:
333
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Adana City Hospital
Address:
City:
Adana
Zip:
1060
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Gulhane Training and Research Hospital
Address:
City:
Ankara
Zip:
06010
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Gazi University Hospital
Address:
City:
Ankara
Zip:
06560
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Ankara Bilkent City Hospital
Address:
City:
Ankara
Zip:
6800
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Bakirkoy Training and Research Hospital
Address:
City:
Istanbul
Zip:
34147
Country:
Turkey
Status:
Recruiting
Facility:
Name:
I A U VM Medical Park Florya Hastanesi
Address:
City:
Istanbul
Zip:
34295
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Ege University Medical Faculty
Address:
City:
Izmir
Zip:
35100
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Ondokuz Mayis University
Address:
City:
Samsun
Zip:
55420
Country:
Turkey
Status:
Recruiting
Start date:
February 16, 2024
Completion date:
March 31, 2026
Lead sponsor:
Agency:
Janssen Research & Development, LLC
Agency class:
Industry
Source:
Janssen Research & Development, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06120140
