Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF

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 (COCOON)

Last Updated May 23, 2025

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61186372NSC2007

OVERVIEW

Sexes Eligible for Study
all
Age
18+ years
Phase
phase 2
Sites
93 Sites
Status

Recruiting

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. 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.

CONDITIONS

Carcinoma, Non-Small-Cell Lung

ELIGIBILITY

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
* 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); 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
* 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)

Inclusion Criteria:

More...

DETAILS

LOCATIONS

Locations in:

United States, Argentina, Brazil, China, Germany, Spain, Türkiye, France, South Korea, Malaysia, Taiwan

Country (11)	City or Province (93)	Status
United States	Duarte City of Hope	RECRUITING
United States	Huntington Beach City of Hope Seacliff	RECRUITING
United States	Long Beach City of Hope Long Beach Elm	RECRUITING
United States	Oakland Kaiser Permanente Oakland Medical Center	RECRUITING
United States	Roseville Kaiser Permanente Roseville Medical Center	RECRUITING
United States	San Francisco Kaiser Permanente San Francisco Medical Center	RECRUITING
United States	Santa Clara Kaiser Permanente Santa Clara Medical Center	RECRUITING
United States	South Pasadena City of Hope South Pasadena	RECRUITING
United States	Vallejo Kaiser Permanente Northern California	RECRUITING
United States	Walnut Creek Kaiser Permanente Walnut Creek Medical Center	RECRUITING
United States	Athens University Cancer & Blood Center	RECRUITING
United States	Hinsdale Hope and Healing Care	RECRUITING
United States	Springfield Oncology Hematology Associates	RECRUITING
United States	Reno Renown Health Medical Oncology	RECRUITING
United States	Flemington Hunterdon Hematology Oncology	RECRUITING
United States	Westbury Clinical Research Alliance Inc	RECRUITING
United States	Wilson Regional Medical Oncology Center	RECRUITING
United States	Renton Valley Medical Center	RECRUITING
United States	W. Salem Gundersen Health System	RECRUITING
Argentina	La Plata Hospital Italiano de La Plata	COMPLETED
Brazil	Curitiba Liga Paranaense de Combate ao Cancer	RECRUITING
Brazil	Jaú Fundacao Doutor Amaral Carvalho	RECRUITING
China	Chengdou West China Hospital	ACTIVE_NOT_RECRUITING
China	Guang Zhou The First Affiliated Hospital Sun Yat sen University	ACTIVE_NOT_RECRUITING
China	Nanjing Zhongda Hospital Southeast University	ACTIVE_NOT_RECRUITING
Germany	Aachen Universitaetsklinikum der RWTH Aachen	RECRUITING
Germany	Essen Kliniken Essen-Mitte	RECRUITING
Germany	Giessen Universitaetsklinikum Giessen und Marburg GmbH	RECRUITING
Germany	Kiel Universitaetsklinikum Schleswig Holstein Campus Kiel	RECRUITING
Spain	Alicante Hosp. Gral. Univ. de Alicante	RECRUITING
Spain	Barcelona Hosp Univ Vall D Hebron	ACTIVE_NOT_RECRUITING
Spain	Lugo Hosp. Univ. Lucus Augusti	RECRUITING
Spain	Madrid Hosp. Gral. Univ. Gregorio Maranon	RECRUITING
Türkiye	Samsun Ondokuz Mayis University	RECRUITING
United States	Chandler Ironwood Cancer and Research Center	RECRUITING
United States	Fullerton Providence Fullerton	RECRUITING
United States	Glendale Los Angeles Cancer Network	RECRUITING
United States	Irvine City of Hope Orange County Lennar Foundation Cancer Center	RECRUITING
United States	Los Alamitos Cancer and Blood Specialty Clinic	RECRUITING
United States	Los Angeles Keck Hospital of USC	RECRUITING
United States	Newport Beach USC Norris Oncology Hematology Newport Beach	RECRUITING
United States	Cleveland University Hospitals Cleveland Medical Center	RECRUITING
United States	Fairfax Virginia Cancer Specialists	RECRUITING
Argentina	Buenos Aires Hospital Italiano de Buenos Aires	RECRUITING
Argentina	Caba IADT Instituto Argentino de Diagnostico y Tratamiento	RECRUITING
Argentina	Capital Federal Centro Medico Austral	RECRUITING
Argentina	Mar del Plata Hospital Privado de la Comunidad	RECRUITING
Brazil	Belem CTO Centro De Tratamento Oncologico LTDA	RECRUITING
Brazil	Belo Horizonte Santa Casa de Misericordia de Belo Horizonte	RECRUITING
Brazil	Porto Alegre Hospital Nossa Senhora da Conceicao S A	RECRUITING
Brazil	Salvador Nucleo de Oncologia da Bahia Oncoclinicas	RECRUITING
Brazil	Santa Cruz do Sul Hospital Ana Nery Santa Cruz do Sul	RECRUITING
Brazil	Sao Paulo Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo	RECRUITING
Brazil	Sao Paulo Fundacao Antonio Prudente A C Camargo Cancer Center	RECRUITING
Brazil	Taubate Servicos de Tratamento ao Cancer de Taubate LTDA - Instituto do Cancer Brasil Unidade Taubate	RECRUITING
Brazil	Vitoria Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia	RECRUITING
China	Changzhou Changzhou No 2 Peoples Hospital	RECRUITING
China	Chengdu Sichuan Cancer Hospital	RECRUITING
China	Hangzhou The First Affiliated Hospital Zhejiang University School of Medicine	COMPLETED
China	Harbin Harbin medical university cancer hospital	RECRUITING
China	Huizhou Huizhou Municipal Central Hospital	RECRUITING
China	ShangHai Fudan University Shanghai Cancer Center	RECRUITING
China	Xi'an The First Affiliated Hospital of Xian Jiaotong University	RECRUITING
China	Zhengzhou Henan Cancer Hospital	RECRUITING
France	Marseille Cedex 20 Hopital Nord	RECRUITING
France	Nice Hopital PASTEUR	RECRUITING
France	Paris Institut Curie	RECRUITING
Germany	Heidelberg Thoraxklinik am Universitatsklinikum Heidelberg	RECRUITING
Germany	Kassel Klinikum Kassel GmbH	RECRUITING
South Korea	Cheongju-si Chungbuk National University Hospital	RECRUITING
South Korea	Incheon Gachon University Gil Hospital	RECRUITING
South Korea	Seoul Severance Hospital Yonsei University Health System	RECRUITING
Malaysia	Georgetown Hospital Pulau Pinang	RECRUITING
Malaysia	Kuala Lumpur University Malaya Medical Centre	RECRUITING
Malaysia	Kuantan Hospital Tengku Ampuan Afzan	RECRUITING
Malaysia	Kuching Hospital Umum Sarawak	RECRUITING
Spain	A Coruna Hosp Univ A Coruna	RECRUITING
Spain	Barcelona Hosp. Univ. Quiron Dexeus	RECRUITING
Spain	Jaen Hosp. Univ. de Jaen	RECRUITING
Spain	Malaga Hosp Regional Univ de Malaga	RECRUITING
Spain	Sevilla Hosp. Ntra. Sra. de Valme	RECRUITING
Taiwan	Hsin Chu National Taiwan University Hospital Hsin Chu Branch	RECRUITING
Taiwan	Kaohsiung City Chang Gung Memorial Hospital	RECRUITING
Taiwan	Taichung City Taichung Veterans General Hospital	RECRUITING
Taiwan	Taipei National Taiwan University Hospital	RECRUITING
Taiwan	Taoyuan City Linkou Chang Gung Memorial Hospital	RECRUITING
Türkiye	Adana Adana City Hospital	RECRUITING
Türkiye	Ankara Gulhane Training and Research Hospital	RECRUITING
Türkiye	Ankara Gazi University Hospital	RECRUITING
Türkiye	Ankara Ankara Bilkent City Hospital	RECRUITING
Türkiye	Istanbul Bakirkoy Training and Research Hospital	RECRUITING
Türkiye	Istanbul I A U VM Medical Park Florya Hastanesi	RECRUITING
Türkiye	Izmir Ege University Medical Faculty	RECRUITING

Geo Locations

34.13945, -117.97729

33.6603, -117.99923

33.76696, -118.18923

37.80437, -122.2708

38.75212, -121.28801

37.77493, -122.41942

37.35411, -121.95524

34.11612, -118.15035

38.10409, -122.25664

37.90631, -122.06496

33.96095, -83.37794

41.80086, -87.93701

37.21533, -93.29824

39.52963, -119.8138

40.51233, -74.85933

40.75566, -73.58763

35.72127, -77.91554

47.48288, -122.21707

43.89913, -91.08125

-34.92145, -57.95453

-25.42778, -49.27306

-22.29639, -48.55778

25.71055, 116.97865

23.1291999, 113.303

32.06167, 118.77778

50.77664, 6.08342

51.45657, 7.01228

50.58727, 8.67554

54.32133, 10.13489

38.34517, -0.48149

41.38879, 2.15899

43.00992, -7.55602

40.4165, -3.70256

41.27976, 36.3361

33.30616, -111.84125

33.87029, -117.92534

34.14251, -118.25508

33.66946, -117.82311

33.80307, -118.07256

34.05223, -118.24368

33.61891, -117.92895

41.4995, -81.69541

38.84622, -77.30637

-34.61315, -58.37723

-38.00228, -57.55754

-1.45583, -48.50444

-19.92083, -43.93778

-30.03306, -51.23

-12.97111, -38.51083

-29.7175, -52.42583

-23.5475, -46.63611

-23.02639, -45.55528

-20.31944, -40.33778

31.77359, 119.95401

30.66667, 104.06667

30.29365, 120.16142

45.75, 126.65

23.11147, 114.41523

31.22222, 121.45806

34.25833, 108.92861

34.75778, 113.64861

43.29551, 5.38958

43.70313, 7.26608

48.85341, 2.3488

49.40768, 8.69079

51.31667, 9.5

36.63722, 127.48972

37.45646, 126.70515

37.566, 126.9784

5.4197312, 100.3170452

3.1412, 101.68653

3.8077, 103.326

1.54999, 110.33333

43.37135, -8.396

41.38879, 2.15899

37.76922, -3.79028

36.72016, -4.42034

37.38283, -5.97317

24.8138287, 120.9674798

22.61626, 120.31333

24.1469, 120.6839

25.04776, 121.53185

24.95233, 121.20193

37.00167, 35.32889

39.91987, 32.85427

41.01384, 28.94966

38.41273, 27.13838

Indicates 50+ sites in this region: click to zoom in.

Indicates 10+ sites in this region: click to zoom in.

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

OVERVIEW

Sexes Eligible for Study

Age

Phase

Sites

Status

SUMMARY

CONDITIONS

ELIGIBILITY

DETAILS

LOCATIONS

34.13945, -117.97729

33.6603, -117.99923

33.76696, -118.18923

37.80437, -122.2708

38.75212, -121.28801

37.77493, -122.41942

37.35411, -121.95524

34.11612, -118.15035

38.10409, -122.25664

37.90631, -122.06496

33.96095, -83.37794

41.80086, -87.93701

37.21533, -93.29824

39.52963, -119.8138

40.51233, -74.85933

40.75566, -73.58763

35.72127, -77.91554

47.48288, -122.21707

43.89913, -91.08125

-34.92145, -57.95453

-25.42778, -49.27306

-22.29639, -48.55778

25.71055, 116.97865

23.1291999, 113.303

32.06167, 118.77778

50.77664, 6.08342

51.45657, 7.01228

50.58727, 8.67554

54.32133, 10.13489

38.34517, -0.48149

41.38879, 2.15899

43.00992, -7.55602

40.4165, -3.70256

41.27976, 36.3361

33.30616, -111.84125

33.87029, -117.92534

34.14251, -118.25508

33.66946, -117.82311

33.80307, -118.07256

34.05223, -118.24368

33.61891, -117.92895

41.4995, -81.69541

38.84622, -77.30637

-34.61315, -58.37723

-34.61315, -58.37723

-34.61315, -58.37723

-38.00228, -57.55754

-1.45583, -48.50444

-19.92083, -43.93778

-30.03306, -51.23

-12.97111, -38.51083

-29.7175, -52.42583

-23.5475, -46.63611

-23.5475, -46.63611

-23.02639, -45.55528

-20.31944, -40.33778

31.77359, 119.95401

30.66667, 104.06667

30.29365, 120.16142

45.75, 126.65

23.11147, 114.41523

31.22222, 121.45806

34.25833, 108.92861

34.75778, 113.64861

43.29551, 5.38958

43.70313, 7.26608

48.85341, 2.3488

49.40768, 8.69079

51.31667, 9.5