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, 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
Janssen Research & Development, LLC
300 participants
Feb 16, 2024
INTERVENTIONAL
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.
Eligibility
Plain Language Summary
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Interventions
Amivantamab will be administered.
Amivantamab will be administered as SC injection.
Lazertinib tablet will be administered orally.
Doxycycline tablet will be administered orally.
Minocycline capsule will be administered orally.
Clindamycin lotion will be used as topical application on the scalp.
Chlorhexidine solution will be used as topical application on hands and feet.
Noncomedogenic skin moisturizer will be used as topical application.
Ruxolitinib will be used to the affected skin area.
Tacrolimus will be used as topical application to the affected skin area.
Zinc gluconate tablet will be administered.
Propranolol tablet will be administered.
Timolol will be used to the affected skin area.
Clobetasol shampoo will be used on the scalp.
Locations(93)
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NCT06120140