{"commentary":{"count":3,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":3},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":false},"name":"COCOON","nct_id":"NCT06120140","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=cocoon-nct06120140. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–12 commentary sources"},"registry":{"acronym":"COCOON","arms":[{"description":"Participants 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).","label":"Arm A: Enhanced Dermatologic Management","type":"EXPERIMENTAL"},{"description":"Participants 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.","label":"Arm B: Standard-of-Care Dermatologic Management","type":"ACTIVE_COMPARATOR"},{"description":"Participants 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.","label":"Sub-study: Cohort A: Ruxolitinib","type":"EXPERIMENTAL"},{"description":"Participants 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.","label":"Sub-study: Cohort B: Tacrolimus","type":"EXPERIMENTAL"},{"description":"Participants 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.","label":"Amivantamab Subcutaneous (SC) Expansion Cohort: Standard Schedule","type":"EXPERIMENTAL"},{"description":"Participants 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.","label":"Amivantamab SC Expansion Cohort: Modified Schedule","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2030-06-30","type":"ESTIMATED"},"conditions":["Carcinoma, Non-Small-Cell Lung"],"enrollment":{"count":305,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Amivantamab IV","type":"DRUG"},{"name":"Amivantamab SC","type":"DRUG"},{"name":"Lazertinib","type":"DRUG"},{"name":"Doxycycline","type":"DRUG"},{"name":"Minocycline","type":"DRUG"},{"name":"Clindamycin","type":"DRUG"},{"name":"Chlorhexidine","type":"DRUG"},{"name":"Noncomedogenic skin moisturizer","type":"OTHER"},{"name":"Ruxolitinib","type":"OTHER"},{"name":"Tacrolimus","type":"OTHER"},{"name":"Zinc gluconate","type":"DRUG"},{"name":"Propranolol","type":"DRUG"},{"name":"Timolol","type":"DRUG"},{"name":"Clobetasol","type":"DRUG"}],"last_update":"2026-09-25","lead_sponsor":"Janssen Research & Development, LLC","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","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2027-05-31","type":"ESTIMATED"},"primary_outcomes":[{"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","timeFrame":"Up to 12 weeks after initiation of anticancer treatment"}],"references":[{"citation":"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.","pmid":"40923969","type":"DERIVED"}],"start_date":{"date":"2024-02-16","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"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","url":"https://clinicaltrials.gov/study/NCT06120140"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/cocoon-nct06120140"}