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AzTrials

Carcinoma, Non-Small-Cell LungPhase 2COCOONNCT06120140

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

A Phase 2 study testing Amivantamab IV, Amivantamab SC and Lazertinib in people with Carcinoma, Non-Small-Cell Lung, run by Janssen Research & Development, LLC at 93 sites in 11 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Amivantamab IV, Amivantamab SC and Lazertinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
305 participants
Where
93 sitesin 11 countries
Study dates
16 Feb 2024to 30 Jun 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

93 sites in 11 countries.

93 sites in 11 countries

United States28 sites

  • University Cancer & Blood Center

    Athens, Georgia, 30607

  • Ironwood Cancer and Research Center

    Chandler, Arizona, 85224

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • City of Hope

    Duarte, California, 91010

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Hunterdon Hematology Oncology

    Flemington, New Jersey, 08822

  • Providence Fullerton

    Fullerton, California, 92835

  • Los Angeles Cancer Network

    Glendale, California, 91204

  • Hope and Healing Care

    Hinsdale, Illinois, 60521

  • City of Hope Seacliff

    Huntington Beach, California, 92648

  • City of Hope Orange County Lennar Foundation Cancer Center

    Irvine, California, 92618

  • City of Hope Long Beach Elm

    Long Beach, California, 90813

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

  • Keck Hospital of USC

    Los Angeles, California, 90033

  • USC Norris Oncology Hematology Newport Beach

    Newport Beach, California, 92663

  • Kaiser Permanente Oakland Medical Center

    Oakland, California, 94611

  • Renown Health Medical Oncology

    Reno, Nevada, 89502

  • Valley Medical Center

    Renton, Washington, 98055

  • Kaiser Permanente Roseville Medical Center

    Roseville, California, 95661

  • Kaiser Permanente San Francisco Medical Center

    San Francisco, California, 94115

  • Kaiser Permanente Santa Clara Medical Center

    Santa Clara, California, 95051

  • City of Hope South Pasadena

    South Pasadena, California, 91030

  • Oncology Hematology Associates

    Springfield, Missouri, 65807

  • Kaiser Permanente Northern California

    Vallejo, California, 94589

  • Kaiser Permanente Walnut Creek Medical Center

    Walnut Creek, California, 94596

  • Gundersen Health System

    West Salem, Wisconsin, 54669

  • Clinical Research Alliance Inc

    Westbury, New York, 11590

  • Regional Medical Oncology Center

    Wilson, North Carolina, 27893

Other trials in United States

Brazil11 sites

  • CTO Centro De Tratamento Oncologico LTDA

    Belém, 66.073-005

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, 30150-221

  • Liga Paranaense de Combate ao Cancer

    Curitiba, 81520-060

  • Fundacao Doutor Amaral Carvalho

    Jaú, 17.210-080

  • Hospital Nossa Senhora da Conceicao S A

    Porto Alegre, 91350 200

  • Nucleo de Oncologia da Bahia Oncoclinicas

    Salvador, 40170 070

  • Hospital Ana Nery Santa Cruz do Sul

    Santa Cruz do Sul, 96835-100

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

    São Paulo, 01246 000

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900

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

    Taubaté, 12030-200

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

    Vitória, 29043-260

Other trials in Brazil

China11 sites

  • Changzhou No 2 Peoples Hospital

    Changzhou, 213004

  • West China Hospital

    Chengdoucun, 610041

  • Sichuan Cancer Hospital

    Chengdu, 610041

  • The First Affiliated Hospital Sun Yat sen University

    Guangzhou, 510080

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, 310003

  • Harbin medical university cancer hospital

    Harbin, 150040

  • Huizhou Municipal Central Hospital

    Huizhou, 516001

  • Zhongda Hospital Southeast University

    Nanjing, 210000

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710061

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Spain9 sites

  • Hosp Univ A Coruna

    A Coruña, 15006

  • Hosp. Gral. Univ. de Alicante

    Alicante, 03010

  • Hosp. Univ. Quiron Dexeus

    Barcelona, 08028

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

  • Hosp. Univ. de Jaen

    Jaén, 23007

  • Hosp. Univ. Lucus Augusti

    Lugo, 27003

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007

  • Hosp Regional Univ de Malaga

    Málaga, 29010

  • Hosp. Ntra. Sra. de Valme

    Seville, 41014

Other trials in Spain

Turkey (Türkiye)8 sites

  • Adana City Hospital

    Adana, 1060

  • Gulhane Training and Research Hospital

    Ankara, 06010

  • Gazi University Hospital

    Ankara, 06560

  • Ankara Bilkent City Hospital

    Ankara, 6800

  • Bakirkoy Training and Research Hospital

    Istanbul, 34147

  • I A U VM Medical Park Florya Hastanesi

    Istanbul, 34295

  • Ege University Medical Faculty

    Izmir, 35100

  • Ondokuz Mayis University

    Samsun, 55420

Other trials in Turkey (Türkiye)

Germany6 sites

  • Universitaetsklinikum der RWTH Aachen

    Aachen, 52074

  • Kliniken Essen-Mitte

    Essen, 45136

  • Universitaetsklinikum Giessen und Marburg GmbH

    Giessen, 35392

  • Thoraxklinik am Universitatsklinikum Heidelberg

    Heidelberg, 69126

  • Klinikum Kassel GmbH

    Kassel, 34125

  • Universitaetsklinikum Schleswig Holstein Campus Kiel

    Kiel, 24105

Other trials in Germany

Argentina5 sites

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199

  • IADT Instituto Argentino de Diagnostico y Tratamiento

    CABA, C1122

  • Centro Medico Austral

    Capital Federal, C1017

  • Hospital Italiano de La Plata

    La Plata, B1900AXI

  • Hospital Privado de la Comunidad

    Mar del Plata, B7602

Other trials in Argentina

Taiwan5 sites

  • National Taiwan University Hospital Hsin Chu Branch

    Hsinchu, 30059

  • Chang Gung Memorial Hospital

    Kaohsiung City, 833

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Taiwan University Hospital

    Taipei, 100

  • Linkou Chang Gung Memorial Hospital

    Taoyuan City, 333

Other trials in Taiwan

Malaysia4 sites

  • Hospital Pulau Pinang

    George Town, 10450

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100

  • Hospital Umum Sarawak

    Kuching, 93586

Other trials in Malaysia

France3 sites

  • Hopital Nord

    Marseille, 13915

  • Hopital PASTEUR

    Nice, 06001

  • Institut Curie

    Paris, 75005

Other trials in France

South Korea3 sites

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

Other trials in South Korea

About this study

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

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.

Being tested
Amivantamab IV, Amivantamab SC, Lazertinib, Doxycycline, Minocycline
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Amivantamab IVDrug

    Also called JNJ-61186372

    Amivantamab will be administered.

  • Amivantamab SCDrug

    Also called JNJ-61186372

    Amivantamab will be administered as SC injection.

  • LazertinibDrug

    Also called JNJ-73841937

    Lazertinib tablet will be administered orally.

  • DoxycyclineDrug

    Doxycycline tablet will be administered orally.

  • MinocyclineDrug

    Minocycline capsule will be administered orally.

  • ClindamycinDrug

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

  • ChlorhexidineDrug

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

  • Noncomedogenic skin moisturizerOther

    Noncomedogenic skin moisturizer will be used as topical application.

  • RuxolitinibOther

    Ruxolitinib will be used to the affected skin area.

  • TacrolimusOther

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

  • Zinc gluconateDrug

    Zinc gluconate tablet will be administered.

  • PropranololDrug

    Propranolol tablet will be administered.

  • TimololDrug

    Timolol will be used to the affected skin area.

  • ClobetasolDrug

    Clobetasol shampoo will be used on the scalp.

Study groups in NCT06120140
Study groupRoleWhat they receive
Arm A: Enhanced Dermatologic ManagementExperimentalParticipants will receive enhanced dermatologic management to reduce toxicities in skin and nail with doxycycline tablet or minocycline capsule, clindamycin topical lotion, chlorhexidine topical solution, and noncomedogenic skin moisturizer during background anticancer treatment of advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) with amivantamab intravenously (Dose 1 for body weight [BW] less than 80 kilograms [kg] and Dose 2 for BW greater than or equal to [>=] 80 kg as IV infusion [Arm A]) until documented disease progression using Response Evaluation Criteria in Solid Tumors version 1.1).
Receives: Drug: Amivantamab IV; Drug: Lazertinib; Drug: Doxycycline; Drug: Minocycline; Drug: Clindamycin; Drug: Chlorhexidine; Other: Noncomedogenic skin moisturizer
Arm B: Standard-of-Care Dermatologic ManagementActive comparatorParticipants will receive standard care for dermatologic management according to local practice to reduce dermatologic toxicities in skin and nail during background anticancer treatment of advanced or metastatic EGFR-mutated NSCLC with amivantamab administered as IV infusion plus lazertinib, dose and dosing schedule as same as experimental arm.
Receives: Drug: Amivantamab IV; Drug: Lazertinib; Drug: Chlorhexidine; Other: Noncomedogenic skin moisturizer
Sub-study: Cohort A: RuxolitinibExperimentalParticipants enrolled in Arms A and B of the main study who experience new-onset or persistent specific DAEIs (Grade greater than or equal to [>=] 2, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] v5.0) will be enrolled and receive reactive treatment with ruxolitinib in the sub-study. Participants in the sub-study will continue to receive amivantamab and lazertinib.
Receives: Drug: Amivantamab IV; Drug: Lazertinib; Drug: Doxycycline; Drug: Minocycline; Drug: Clindamycin; Drug: Chlorhexidine; Other: Noncomedogenic skin moisturizer; Other: Ruxolitinib
Sub-study: Cohort B: TacrolimusExperimentalParticipants enrolled in Arms A and B of the main study who experience new-onset or persistent specific DAEIs (Grade >= 2, as defined by NCI-CTCAE v5.0) will be enrolled and receive reactive treatment with tacrolimus in the sub-study. Participants in the sub-study will continue to receive amivantamab and lazertinib.
Receives: Drug: Amivantamab IV; Drug: Lazertinib; Drug: Doxycycline; Drug: Minocycline; Drug: Clindamycin; Drug: Chlorhexidine; Other: Noncomedogenic skin moisturizer; Other: Tacrolimus
Amivantamab Subcutaneous (SC) Expansion Cohort: Standard ScheduleExperimentalParticipants will receive modified enhanced dermatologic management with oral doxycycline or minocycline, zinc gluconate and noncomedogenic skin moisturizer during background anticancer treatment of advanced or metastatic EGFR mutated NSCLC with amivantamab SC and lazertinib as per standard schedule. If a participant develops a dermatologic adverse event of interest (DAEI) they will receive early intervention as follows: for facial (ruxolitinib), for scalp (oral propranolol and clobetasol), for paronychia (chlorhexidine in addition to timolol) until documented disease progression using Response Evaluation Criteria in Solid Tumors version 1.1.
Receives: Drug: Amivantamab SC; Drug: Lazertinib; Drug: Doxycycline; Drug: Minocycline; Drug: Chlorhexidine; Other: Noncomedogenic skin moisturizer; Other: Ruxolitinib; Drug: Zinc gluconate; Drug: Propranolol; Drug: Timolol; Drug: Clobetasol
Amivantamab SC Expansion Cohort: Modified ScheduleExperimentalParticipants will receive modified enhanced dermatologic management with oral doxycycline or minocycline, zinc gluconate and noncomedogenic skin moisturizer during background anticancer treatment of advanced or metastatic EGFR mutated NSCLC with amivantamab SC and lazertinib as per modified schedule. If a participant develops a DAEI they will receive early intervention as follows: for facial (ruxolitinib), for scalp (oral propranolol and clobetasol), for paronychia (chlorhexidine in addition to timolol) until documented disease progression using Response Evaluation Criteria in Solid Tumors version 1.1.
Receives: Drug: Amivantamab SC; Drug: Lazertinib; Drug: Doxycycline; Drug: Minocycline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Grade Greater Than or Equal to (>=) 2 Dermatologic Adverse Events of Interest (DAEIs) Within 12 Weeks After Initiation of Anticancer Treatment

    Number of participants with Grade >= 2 DAEIs within 12 weeks after initiation of anticancer treatment based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version (v) 5.0 will be reported. DAEIs includes rash, dermatitis acneiform, pruritus, skin fissures, acne, folliculitis, erythema, eczema, rash maculo-papular, skin exfoliation, skin lesion, skin irritation, dermatitis, rash erythematous, rash macular, rash popular, rash pruritic, rash pustular, dermatitis contact, dermatitis exfoliative generalized, drug eruption, dyshidrotic eczema, eczema asteatotic and paronychia. As per NCI CTCAE v 5.0, severity scale ranges from Grade 1 (mild) to Grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, and Grade 5= death related to adverse event.

    Measured: Up to 12 weeks after initiation of anticancer treatment

Secondary outcomes (21)

  1. Number of Participants With DAEIs by Severity Based on NCI-CTCAE v 5.0

    Number of participants with DAEIs by severity based on NCI-CTCAE v 5.0 will be reported.

    Measured: Up to 12 weeks after initiation of anticancer treatment

  2. Number of Participants With Grade >=2 DAEIs Within 6 Months After Initiation of Anticancer Treatment Based on NCI-CTCAE v 5.0

    Number of participants with Grade >=2 DAEIs within 6 months after initiation of anticancer treatment based on NCI-CTCAE v 5.0 will be reported.

    Measured: Up to 6 months after initiation of anticancer treatment

  3. Number of Grade >= 2 DAEI Per Participants

    Number of grade >= 2 DAEI per participants will be reported.

    Measured: Up to 12 months

  4. Time to First Occurrence of Grade >=2 DAEI

    Time to first occurrence of Grade >=2 DAEI will be reported.

    Measured: Up to 12 months

  5. Time to Resolution of Grade >= 2 DAEI

    Time to resolution of Grade >= 2 DAEI will be reported.

    Measured: Up to 12 months

  6. Number of Participants With Paronychia by Severity Based on NCI-CTCAE v 5.0

    Number of participants with paronychia by severity based on NCI-CTCAE v 5.0 will be reported.

    Measured: Up to 6 months after initiation of anticancer treatment

  7. Number of Participants With Scalp Rash by Severity Based on NCI-CTCAE v 5.0

    Number of participants with scalp rash by severity based on NCI-CTCAE v 5.0 will be reported.

    Measured: Up to 12 months after initiation of anticancer treatment

  8. Change From Baseline in Skindex Symptoms Domain Score up to 12 Months

    Change from baseline in skindex symptoms domain score up to 12 months will be reported. The score of quality of life will be assessed using the Skindex-16 questionnaire. Skindex-16 is used for participants to rate skin conditions.

    Measured: Baseline, up to Month 12

  9. Change From Baseline in Patient's Global Impression-Severity (PGI-S) Rash up to 12 Months

    Change from baseline in PGI-S rash up to 12 months will be reported. Participant quality of life will be evaluated using PGI-S Rash. PGI-S is a single-item questionnaire assessing participants disease severity on a 7-point response scale.

    Measured: Baseline, up to Month 12

  10. Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Score up to 12 Months

    Change from baseline in EORTC-QLQ-C30 score up to 12 months will be reported. EORTC-QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies.

    Measured: Baseline, up to Month 12

  11. Change From Baseline in EuroQol 5 - Dimension (EQ-5D) Patient-reported Outcome (PRO) up to 12 Months (for Amivantamab Subcutaneous Expansion Cohort Only)

    The EQ-5D questionnaire is a brief, generic HRQOL assessment that can that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. EQ-5D scores include EQ-5D valuation index score (a weighted scoring of the 5 dimension scores with a possible range from 0 to 1), EQ-5D visual analog scale (VAS) is a vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health), and EQ5D descriptive system scores (five scores reflecting each of the 5 EQ-5D health dimensions ranging from 0 [no limitation] to 4 [incapacity]).

    Measured: Baseline, up to Month 12

  12. Percentage of Participants With Dose Reductions, Dose Interruptions, and Dose Discontinuations of Anticancer Treatment due to DAEIs

    Percentage of participants with dose reductions, dose interruptions, and dose discontinuations of anticancer treatment due to DAEIs will be reported.

    Measured: Up to 12 months

  13. Relative Dose Intensity (RDI) of Anticancer Treatment

    Relative dose intensity of anticancer treatment will be reported. The relative dose intensity is defined as the ratio of total actually received dose versus total prescribed dose.

    Measured: Up to 12 months

  14. Percentage of Participants With Venous Thromboembolism (VTE) Adverse Events (AEs) by Severity Based on NCI-CTCAE v 5.0

    Percentage of participants with VTE AEs (pulmonary embolism and deep vein thrombosis) by severity based on NCI-CTCAE v 5.0 will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.

    Measured: Up to 12 months

  15. Percentage of Participants With Adverse Events (AEs) by Severity Based on NCI-CTCAE v 5.0

    Percentage of participants with AEs by severity based on NCI-CTCAE v 5.0 will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.

    Measured: Up to 12 months

  16. Progression Free Survival (PFS)

    PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death due to any cause, whichever occurs first.

    Measured: Up to 12 months

  17. Overall Response Rate (ORR)

    ORR is defined as the percentage of participants who achieve a partial response (PR) or better response using RECIST v1.1 as assessed by the investigator.

    Measured: Up to 12 months

  18. Duration of Response (DoR)

    DOR will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the RECIST v1.1 response criteria.

    Measured: Up to 12 months

  19. Amivantamab SC Expansion Cohorts: Number of Participants With Grade >= 2 DAEIs Within 12 Weeks After Initiation of Anticancer Treatment

    Participants with Grade >= 2 DAEIs within 12 weeks after initiation of anticancer treatment based on NCI-CTCAE v 5.0 will be reported. DAEIs includes rash, dermatitis acneiform, pruritus, skin fissures, acne, folliculitis, erythema, eczema, rash maculo-papular, skin exfoliation, skin lesion, skin irritation, dermatitis, rash erythematous, rash macular, rash popular, rash pruritic, rash pustular, dermatitis contact, dermatitis exfoliative generalized, drug eruption, dyshidrotic eczema, eczema asteatotic and paronychia. As per NCI-CTCAE v 5.0, severity scale ranges from Grade 1 (mild) to Grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, and Grade 5= death related to adverse event.

    Measured: Up to 12 weeks after initiation of anticancer treatment

  20. Amivantamab SC Expansion Cohorts: Percentage of Participants With an Improvement in DAEI After Starting Early Intervention

    Percentage of participants showing an improvement in DAEI by a minimum of 1 NCI-CTCAE grade after starting early intervention will be reported. As per NCI-CTCAE v 5.0, severity scale ranges from Grade 1 (mild) to Grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, and Grade 5= death related to adverse event.

    Measured: Up to 12 months

  21. Amivantamab SC Expansion Cohorts: Time to Improvement of DAEIs After Starting Early Intervention

    Time to improvement of DAEIs by a minimum of 1 NCI-CTCAE grade after starting early intervention will be reported. As per NCI-CTCAE v 5.0, severity scale ranges from Grade 1 (mild) to Grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, and Grade 5= death related to adverse event.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2023
  2. Study start16 Feb 2024
  3. Primary completion31 May 2027 (estimated)
  4. Study completion30 Jun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06120140
Sponsor's protocol ID
61186372NSC2007
Other IDs
61186372NSC2007, 2023-505863-35-00, 2023
Acronym
COCOON
Status last verified
Nov 2026
First submitted
2 Nov 2023
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Publications

  • Cho BC, Li W, Spira AI, Sauder M, Feldman J, Bozorgmehr F, Mak M, Smith J, Voon PJ, Liu B, Tian P, Tan JL, Yang CT, Shih JY, Karadurmus N, Cundom JE, Bertollo G, Cicin I, Nieva J, Ortega-Granados AL, Tomasini P, Nguyen D, Felip E, Schuchard J, Murphy SP, Anderson BG, Romero T, Xia Y, Sheng S, Bauml JM, Mahadevia PJ, Kam J, Nematian-Samani M, Simoes J, Wildgust M, Girard N. Enhanced Versus Standard Dermatologic Management With Amivantamab-Lazertinib in EGFR-Mutated Advanced NSCLC: The COCOON Global Randomized Controlled Trial. J Thorac Oncol. 2025 Oct;20(10):1517-1530. doi: 10.1016/j.jtho.2025.07.117. Epub 2025 Sep 9.

    PubMed 40923969

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Amivantamab IV, Amivantamab SC and Lazertinib in people with Carcinoma, Non-Small-Cell Lung, run by Janssen Research & Development, LLC at 93 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in United States, Brazil, China, Spain, Turkey (Türkiye) and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Grade Greater Than or Equal to (>=) 2 Dermatologic Adverse Events of Interest (DAEIs) Within 12 Weeks After Initiation of Anticancer Treatment (time frame: Up to 12 weeks after initiation of anticancer treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06120140, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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