Evidence map›Paper›PMID 40923969›Full record

Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2025

Enhanced Versus Standard Dermatologic Management With Amivantamab-Lazertinib in EGFR-Mutated Advanced NSCLC: The COCOON Global Randomized Controlled Trial.

Byoung Chul Cho, Weimin Li, Alexander I Spira, Maxwell Sauder, Jill Feldman, Farastuk Bozorgmehr, Milena Mak, Janellen Smith, Pei Jye Voon, Baogang Liu and 26 more

2 registry-linked trialsAbstract readRandomized Controlled TrialClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 31 papers.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06120140 phase2active not recruitingnot on this map

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

TypeinterventionalSponsorJanssen Research & Development, LLCRan2024 to 2030Enrolled305ConditionsCarcinoma, Non-Small-Cell LungArmsAmivantamab IV, Amivantamab SC, Lazertinib, Doxycycline, Minocycline
NCT07469488 phase4not yet recruitingnot on this mapstarted 2026, after this paper: background citation

AmiCARE: A Clinical Trial on the Outcomes of Comprehensive Enhanced Prophylaxis Management (CEPM) in Chinese Patients With EGFR-Mutated Advanced NSCLC Receiving Amivantamab-Based Regimens

TypeinterventionalSponsorShanghai Pulmonary Hospital, Shanghai, ChinaRan2026 to 2029Enrolled122ConditionsNSCLC (Advanced Non-small Cell Lung Cancer), VTE (Venous Thromboembolism), Rash Due to Epidermal Growth Factor Receptor Inhibitors, Infusion ReactionArmsEnhanced dermatologic management, Enhanced IRR Prophylaxis, Enhanced VTE Prophylaxis (Cohort 1 only)
3 · Its place in the literature

Who cites it

31 citing papers in PubMed.

  1. Phase 2 Study of Amivantamab Plus Lazertinib in Previously Treated Patients With EGFR-Mutant Lung Cancers With Brain and Leptomeningeal Metastases.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2026
    Trial
  2. Review
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  6. Dermatologic adverse events associated with amivantamab: A multicentre study.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Article
  7. Article
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  9. Article
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  11. Targeting ClassicalCancers · 2026
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

36 authors.

Byoung Chul ChoDivision of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: CBC1971@yuhs.ac.
Weimin LiDepartment of Pulmonary Care and Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China.
Alexander I SpiraVirginia Cancer Specialists, Fairfax, Virginia.
Maxwell SauderUniversity of Toronto, Toronto, Ontario, Canada; Princess Margaret Cancer Centre, Toronto, Ontario, Canada.
Jill FeldmanEGFR Resisters, Deerfield, Illinois.
Farastuk BozorgmehrThoraxklinik Heidelberg gGmbH, University Hospital Heidelberg, Heidelberg, Germany.
Milena MakInstituto do Câncer do Estado de São Paulo - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
Janellen SmithUniversity of California - Irvine, Irvine, California.
Pei Jye VoonDepartment of Radiotherapy and Oncology, Sarawak General Hospital, Kuching, Sarawak, Malaysia.
Baogang LiuHarbin Medical University Cancer Hospital, Harbin, People's Republic of China.
Panwen TianDepartment of Pulmonary Care and Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China.
Jiunn-Liang TanDepartment of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
Cheng-Ta YangDepartment of Internal Medicine, Division of Thoracic Medicine, Linkou Chang Gung Memorial Hospital; College of Medicine, Chang Gung University, Taoyuan, Taiwan.
Jin-Yuan ShihDepartment of Internal Medicine, National Taiwan University Hospital, Taipei City, Taiwan.
Nuri KaradurmusGülhane Training and Research Hospital, Ankara, Turkey.
Juan Esteban CundomInstituto Argentino de Diagnóstico y Tratamiento (IADT), Buenos Aires, Argentina.
Glaucio BertolloAFECC/Hospital Santa Rita de Cássia, Vitória-ES, Brazil.
Irfan Cicinİstinye University Medical Oncology and İ.A.Ü. VM Medical Park Florya Hospital, Istanbul, Turkey.
Jorge NievaUniversity of Southern California/Norris Comprehensive Cancer Center, Los Angeles, California.
Ana Laura Ortega-GranadosServicio de Oncologia Médica, Hospital Universitario de Jaén, Jaén, Spain.
Pascale TomasiniHôpitaux de Marseille, Aix-Marseille University, Marseille, France.
Danny NguyenCity of Hope National Medical Center, Duarte, California.
Enriqueta FelipMedical Oncology Service, Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain.
Julia SchuchardJohnson & Johnson, Horsham, Pennsylvania.
Sean P MurphyJohnson & Johnson, Raritan, New Jersey.
Bailey G AndersonJohnson & Johnson, Raritan, New Jersey.
Tonatiuh RomeroJohnson & Johnson, Raritan, New Jersey.
Yichuan XiaJohnson & Johnson, Spring House, Pennsylvania.
Shubin ShengJohnson & Johnson, Raritan, New Jersey.
Joshua M BaumlJohnson & Johnson, Spring House, Pennsylvania.
Parthiv J MahadeviaJohnson & Johnson, Raritan, New Jersey.
Julian KamJohnson & Johnson, Raritan, New Jersey.
Mehregan Nematian-SamaniJohnson & Johnson, Raritan, New Jersey.
Jairo SimoesJohnson & Johnson, Raritan, New Jersey.
Mark WildgustJohnson & Johnson, Raritan, New Jersey.
Nicolas GirardInstitut du Thorax Curie-Montsouris, Paris, France; Paris-Saclay University, UVSQ-Versailles, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAmivantamab plus lazertinib significantly improved progression-free and overall survival versus osimertinib in patients with previously untreated, EGFR-mutant advanced NSCLC. EGFR-targeted therapies are associated with dermatologic adverse events (AEs), which can affect quality of life (QoL). COCOON was conducted to assess prophylactic management and improve treatment experience.

methodsIn the phase 2 COCOON study (NCT06120140), participants with previously untreated, EGFR-mutant, locally advanced or metastatic NSCLC received intravenous amivantamab plus oral lazertinib and were randomized 1:1 to enhanced dermatologic management (COCOON DM) or standard of care (SoC DM) per local guidelines. COCOON DM included oral doxycycline or minocycline (100 mg twice daily; weeks 1-12), clindamycin 1% (on scalp daily; weeks 13-52), chlorhexidine 4% (on fingernails and toenails daily), and ceramide-based moisturizer (on body and face at least daily). Primary end point was incidence of grade 2 or higher dermatologic AEs of interest (DAEIs) by week 12.

resultsIn total, 201 participants were randomized (99 to COCOON DM and 102 to SoC DM). At a median follow-up of 7.1 months, COCOON DM demonstrated significant reduction in the primary end point versus SoC DM (42% versus 75%; OR, 0.24; 95% confidence interval, 0.13-0.45; p < 0.0001). By week 12, the largest benefit with COCOON DM was observed in DAEIs involving the face and body (excludes paronychia; 26% versus 60%; p < 0.0001) and DAEIs involving the scalp (10% versus 26%; p = 0.0049). This benefit was maintained at 6 months, with significant reductions of DAEIs involving face, body, and scalp (excluding paronychia). Patient-reported outcomes favored COCOON DM, indicating reduced impact of dermatologic symptoms on QoL.

conclusionAn uncomplicated, widely available, prophylactic regimen (COCOON DM) reduced the incidence of DAEIs with amivantamab-lazertinib and the impact of symptoms on QoL.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungLung NeoplasmsQuinolinesAdultAgedErbB ReceptorsFemaleHumansMaleMiddle AgedMutationQuality of LifeEGFR protein, humanErbB ReceptorsQuinolinesAmivantamabDermatologic adverse eventsDermatologic managementLazertinibNon–small cell lung cancer

Identifiers

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.