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New study aims to tame skin rashes in lung cancer therapy

NCT ID NCT06120140

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study looks at whether special skin care can lower the chance of bad skin reactions in people with advanced lung cancer who are taking a combination of two drugs (amivantamab and lazertinib). About 305 participants will be randomly assigned to standard skin care or enhanced skin care. The goal is to see if the enhanced approach reduces moderate to severe skin problems like rash, itching, or nail changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

305 people

The number who actually took part.

Started

Feb 2024

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung

Contacts and locations

Locations

  • Adana City Hospital

    Adana, 1060, Turkey (Türkiye)

  • Ankara Bilkent City Hospital

    Ankara, 6800, Turkey (Türkiye)

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

    Vitória, 29043-260, Brazil

  • Bakirkoy Training and Research Hospital

    Istanbul, 34147, Turkey (Türkiye)

  • CTO Centro De Tratamento Oncologico LTDA

    Belém, 66.073-005, Brazil

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720, United States

  • Centro Medico Austral

    Capital Federal, C1017, Argentina

  • Chang Gung Memorial Hospital

    Kaohsiung City, 833, Taiwan

  • Changzhou No 2 Peoples Hospital

    Changzhou, 213004, China

  • Chungbuk National University Hospital

    Cheongju-si, 28644, South Korea

  • City of Hope

    Duarte, California, 91010, United States

  • City of Hope Long Beach Elm

    Long Beach, California, 90813, United States

  • City of Hope Orange County Lennar Foundation Cancer Center

    Irvine, California, 92618, United States

  • City of Hope Seacliff

    Huntington Beach, California, 92648, United States

  • City of Hope South Pasadena

    South Pasadena, California, 91030, United States

  • Clinical Research Alliance Inc

    Westbury, New York, 11590, United States

  • Ege University Medical Faculty

    Izmir, 35100, Turkey (Türkiye)

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032, China

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900, Brazil

  • Fundacao Doutor Amaral Carvalho

    Jaú, 17.210-080, Brazil

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

    São Paulo, 01246 000, Brazil

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Gazi University Hospital

    Ankara, 06560, Turkey (Türkiye)

  • Gulhane Training and Research Hospital

    Ankara, 06010, Turkey (Türkiye)

  • Gundersen Health System

    West Salem, Wisconsin, 54669, United States

  • Harbin medical university cancer hospital

    Harbin, 150040, China

  • Henan Cancer Hospital

    Zhengzhou, 450008, China

  • Hope and Healing Care

    Hinsdale, Illinois, 60521, United States

  • Hopital Nord

    Marseille, 13915, France

  • Hopital PASTEUR

    Nice, 06001, France

  • Hosp Regional Univ de Malaga

    Málaga, 29010, Spain

  • Hosp Univ A Coruna

    A Coruña, 15006, Spain

  • Hosp Univ Vall D Hebron

    Barcelona, 08035, Spain

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007, Spain

  • Hosp. Gral. Univ. de Alicante

    Alicante, 03010, Spain

  • Hosp. Ntra. Sra. de Valme

    Seville, 41014, Spain

  • Hosp. Univ. Lucus Augusti

    Lugo, 27003, Spain

  • Hosp. Univ. Quiron Dexeus

    Barcelona, 08028, Spain

  • Hosp. Univ. de Jaen

    Jaén, 23007, Spain

  • Hospital Ana Nery Santa Cruz do Sul

    Santa Cruz do Sul, 96835-100, Brazil

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199, Argentina

  • Hospital Italiano de La Plata

    La Plata, B1900AXI, Argentina

  • Hospital Nossa Senhora da Conceicao S A

    Porto Alegre, 91350 200, Brazil

  • Hospital Privado de la Comunidad

    Mar del Plata, B7602, Argentina

  • Hospital Pulau Pinang

    George Town, 10450, Malaysia

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100, Malaysia

  • Hospital Umum Sarawak

    Kuching, 93586, Malaysia

  • Huizhou Municipal Central Hospital

    Huizhou, 516001, China

  • Hunterdon Hematology Oncology

    Flemington, New Jersey, 08822, United States

  • I A U VM Medical Park Florya Hastanesi

    Istanbul, 34295, Turkey (Türkiye)

  • IADT Instituto Argentino de Diagnostico y Tratamiento

    CABA, C1122, Argentina

  • Institut Curie

    Paris, 75005, France

  • Ironwood Cancer and Research Center

    Chandler, Arizona, 85224, United States

  • Kaiser Permanente Northern California

    Vallejo, California, 94589, United States

  • Kaiser Permanente Oakland Medical Center

    Oakland, California, 94611, United States

  • Kaiser Permanente Roseville Medical Center

    Roseville, California, 95661, United States

  • Kaiser Permanente San Francisco Medical Center

    San Francisco, California, 94115, United States

  • Kaiser Permanente Santa Clara Medical Center

    Santa Clara, California, 95051, United States

  • Kaiser Permanente Walnut Creek Medical Center

    Walnut Creek, California, 94596, United States

  • Keck Hospital of USC

    Los Angeles, California, 90033, United States

  • Kliniken Essen-Mitte

    Essen, 45136, Germany

  • Klinikum Kassel GmbH

    Kassel, 34125, Germany

  • Liga Paranaense de Combate ao Cancer

    Curitiba, 81520-060, Brazil

  • Linkou Chang Gung Memorial Hospital

    Taoyuan City, 333, Taiwan

  • Los Angeles Cancer Network

    Glendale, California, 91204, United States

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • National Taiwan University Hospital Hsin Chu Branch

    Hsinchu, 30059, Taiwan

  • Nucleo de Oncologia da Bahia Oncoclinicas

    Salvador, 40170 070, Brazil

  • Oncology Hematology Associates

    Springfield, Missouri, 65807, United States

  • Ondokuz Mayis University

    Samsun, 55420, Turkey (Türkiye)

  • Providence Fullerton

    Fullerton, California, 92835, United States

  • Regional Medical Oncology Center

    Wilson, North Carolina, 27893, United States

  • Renown Health Medical Oncology

    Reno, Nevada, 89502, United States

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, 30150-221, Brazil

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

    Taubaté, 12030-200, Brazil

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Sichuan Cancer Hospital

    Chengdu, 610041, China

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • The First Affiliated Hospital Sun Yat sen University

    Guangzhou, 510080, China

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, 310003, China

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710061, China

  • Thoraxklinik am Universitatsklinikum Heidelberg

    Heidelberg, 69126, Germany

  • USC Norris Oncology Hematology Newport Beach

    Newport Beach, California, 92663, United States

  • Universitaetsklinikum Giessen und Marburg GmbH

    Giessen, 35392, Germany

  • Universitaetsklinikum Schleswig Holstein Campus Kiel

    Kiel, 24105, Germany

  • Universitaetsklinikum der RWTH Aachen

    Aachen, 52074, Germany

  • University Cancer & Blood Center

    Athens, Georgia, 30607, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University Malaya Medical Centre

    Kuala Lumpur, 59100, Malaysia

  • Valley Medical Center

    Renton, Washington, 98055, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • West China Hospital

    Chengdoucun, 610041, China

  • Zhongda Hospital Southeast University

    Nanjing, 210000, China

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