NCT06120140

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Amivantamab IV	Amivantamab will be administered.
DRUG	Amivantamab SC	Amivantamab will be administered as SC injection.
DRUG	Lazertinib	Lazertinib tablet will be administered orally.
DRUG	Doxycycline	Doxycycline tablet will be administered orally.
DRUG	Minocycline	Minocycline capsule will be administered orally.
DRUG	Clindamycin	Clindamycin lotion will be used as topical application on the scalp.
DRUG	Chlorhexidine	Chlorhexidine solution will be used as topical application on hands and feet.
OTHER	Noncomedogenic skin moisturizer	Noncomedogenic skin moisturizer will be used as topical application.
OTHER	Ruxolitinib	Ruxolitinib will be used to the affected skin area.
OTHER	Tacrolimus	Tacrolimus will be used as topical application to the affected skin area.
DRUG	Zinc gluconate	Zinc gluconate tablet will be administered.
DRUG	Propranolol	Propranolol tablet will be administered.
DRUG	Timolol	Timolol will be used to the affected skin area.
DRUG	Clobetasol	Clobetasol shampoo will be used on the scalp.

Timeline

• Start date: 2024-02-16
• Primary completion: 2027-05-31
• Completion: 2032-01-31
• First posted: 2023-11-07
• Last updated: 2026-04-13

Locations

93 sites across 11 countries: United States, Argentina, Brazil, China, France, Germany, Malaysia, South Korea, Spain, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study