Clinical Trial

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

Study acronym: COCOON
Active, Not Recruiting Phase 2
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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 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.
Protocol Amendment History 2 changes
minor Completion moved earlier: 2032-01-31 -> 2030-06-30 2026-07-07
critical Trial status changed: RECRUITING → ACTIVE_NOT_RECRUITING 2026-05-09
Trial Details
NCT Number NCT06120140
Lead Sponsor Janssen Research & Development, LLC
Conditions Carcinoma, Non-Small-Cell Lung
Enrollment 305 participants
Start Date 2024-02-16
Primary Completion 2027-05-31 (estimated)
Study Completion 2030-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-06