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

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

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.

Sponsors & Collaborators

• Janssen Research & Development, LLC

  lead INDUSTRY

Principal Investigators

• Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-16

Primary Completion

2027-05-31

Completion

2032-01-31

FDA Drug

Yes

Countries

• United States
• Argentina
• Brazil
• China
• France
• Germany
• Malaysia
• South Korea
• Spain
• Taiwan
• Turkey (Türkiye)

Study Locations