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RECRUITING

NCT06120140

PHASE2

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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 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.

Official title: A Phase 2, Open-Label, Randomized Trial Evaluating the Impact of Enhanced Versus Standard Dermatologic Management on Selected Dermatologic Adverse Events Among Patients With Locally Advanced or Metastatic EGFR-Mutated NSCLC Treated First-Line With Amivantamab + Lazertinib

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2024-02-16

Completion Date

2032-01-31

Last Updated

2026-03-13

Healthy Volunteers

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Amivantamab IV

Amivantamab will be administered.

DRUG

Amivantamab SC

Amivantamab will be administered as SC injection.

DRUG

Lazertinib

Lazertinib tablet will be administered orally.

DRUG

Doxycycline

Doxycycline tablet will be administered orally.

DRUG

Minocycline

Minocycline capsule will be administered orally.

DRUG

Clindamycin

Clindamycin lotion will be used as topical application on the scalp.

DRUG

Chlorhexidine

Chlorhexidine solution will be used as topical application on hands and feet.

OTHER

Noncomedogenic skin moisturizer

Noncomedogenic skin moisturizer will be used as topical application.

OTHER

Ruxolitinib

Ruxolitinib will be used to the affected skin area.

OTHER

Tacrolimus

Tacrolimus will be used as topical application to the affected skin area.

DRUG

Zinc gluconate

Zinc gluconate tablet will be administered.

DRUG

Propranolol

Propranolol tablet will be administered.

DRUG

Timolol

Timolol will be used to the affected skin area.

DRUG

Clobetasol

Clobetasol shampoo will be used on the scalp.

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)

Locations (93)

Ironwood Cancer and Research Center

Chandler, Arizona, United States

City of Hope

Duarte, California, United States

Providence Fullerton

Fullerton, California, United States

Los Angeles Cancer Network

Glendale, California, United States

City of Hope Seacliff

Huntington Beach, California, United States

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, United States

City of Hope Long Beach Elm

Long Beach, California, United States

Cancer and Blood Specialty Clinic

Los Alamitos, California, United States

Keck Hospital of USC

Los Angeles, California, United States

USC Norris Oncology Hematology Newport Beach

Newport Beach, California, United States

Kaiser Permanente Oakland Medical Center

Oakland, California, United States

Kaiser Permanente Roseville Medical Center

Roseville, California, United States

Kaiser Permanente San Francisco Medical Center

San Francisco, California, United States

Kaiser Permanente Santa Clara Medical Center

Santa Clara, California, United States

City of Hope South Pasadena

South Pasadena, California, United States

Kaiser Permanente Northern California

Vallejo, California, United States

Kaiser Permanente Walnut Creek Medical Center

Walnut Creek, California, United States

University Cancer & Blood Center

Athens, Georgia, United States

Hope and Healing Care

Hinsdale, Illinois, United States

Oncology Hematology Associates

Springfield, Missouri, United States

Renown Health Medical Oncology

Reno, Nevada, United States

Hunterdon Hematology Oncology

Flemington, New Jersey, United States

Clinical Research Alliance Inc

Westbury, New York, United States

Regional Medical Oncology Center

Wilson, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Valley Medical Center

Renton, Washington, United States

Gundersen Health System

West Salem, Wisconsin, United States

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

IADT Instituto Argentino de Diagnostico y Tratamiento

CABA, Argentina

Centro Medico Austral

Capital Federal, Argentina

Hospital Italiano de La Plata

La Plata, Argentina

Hospital Privado de la Comunidad

Mar del Plata, Argentina

CTO Centro De Tratamento Oncologico LTDA

Belém, Brazil

Santa Casa de Misericordia de Belo Horizonte

Belo Horizonte, Brazil

Liga Paranaense de Combate ao Cancer

Curitiba, Brazil

Fundacao Doutor Amaral Carvalho

Jaú, Brazil

Hospital Nossa Senhora da Conceicao S A

Porto Alegre, Brazil

Nucleo de Oncologia da Bahia Oncoclinicas

Salvador, Brazil

Hospital Ana Nery Santa Cruz do Sul

Santa Cruz do Sul, Brazil

Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

São Paulo, Brazil

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, Brazil

Servicos de Tratamento ao Cancer de Taubate LTDA - Instituto do Cancer Brasil Unidade Taubate

Taubaté, Brazil

Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia

Vitória, Brazil

Changzhou No 2 Peoples Hospital

Changzhou, China

West China Hospital

Chengdoucun, China

Sichuan Cancer Hospital

Chengdu, China

The First Affiliated Hospital Sun Yat sen University

Guangzhou, China

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, China

Harbin medical university cancer hospital

Harbin, China

Huizhou Municipal Central Hospital

Huizhou, China

Zhongda Hospital Southeast University

Nanjing, China

Fudan University Shanghai Cancer Center

Shanghai, China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, China

Henan Cancer Hospital

Zhengzhou, China

Hopital Nord

Marseille, France

Hopital PASTEUR

Nice, France

Institut Curie

Paris, France

Universitaetsklinikum der RWTH Aachen

Aachen, Germany

Kliniken Essen-Mitte

Essen, Germany

Universitaetsklinikum Giessen und Marburg GmbH

Giessen, Germany

Thoraxklinik am Universitatsklinikum Heidelberg

Heidelberg, Germany

Klinikum Kassel GmbH

Kassel, Germany

Universitaetsklinikum Schleswig Holstein Campus Kiel

Kiel, Germany

Hospital Pulau Pinang

George Town, Malaysia

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Hospital Tengku Ampuan Afzan

Kuantan, Malaysia

Hospital Umum Sarawak

Kuching, Malaysia

Chungbuk National University Hospital

Cheongju-si, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Hosp Univ A Coruna

A Coruña, Spain

Hosp. Gral. Univ. de Alicante

Alicante, Spain

Hosp. Univ. Quiron Dexeus

Barcelona, Spain

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp. Univ. de Jaen

Jaén, Spain

Hosp. Univ. Lucus Augusti

Lugo, Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, Spain

Hosp Regional Univ de Malaga

Málaga, Spain

Hosp. Ntra. Sra. de Valme

Seville, Spain

Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan

National Taiwan University Hospital Hsin Chu Branch

Taoyuan District, Taiwan

Adana City Hospital

Adana, Turkey (Türkiye)

Gulhane Training and Research Hospital

Ankara, Turkey (Türkiye)

Gazi University Hospital

Ankara, Turkey (Türkiye)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Bakirkoy Training and Research Hospital

Istanbul, Turkey (Türkiye)

I A U VM Medical Park Florya Hastanesi

Istanbul, Turkey (Türkiye)

Ege University Medical Faculty

Izmir, Turkey (Türkiye)

Ondokuz Mayis University

Samsun, Turkey (Türkiye)

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (93)