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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
Janssen Research & Development, LLC·Phase 2·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Carcinoma, Non-Small-Cell Lung
Drug/Device/Intervention
Amivantamab
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Janssen Research & Development, LLC
Timeline & enrollment
Phase
Phase 2
Start date
Mar 08, 2024
End date
Nov 30, 2026
Enrollment
180 participants
Primary outcome

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

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 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.

ICD-10 classifications
Carcinoma in situ: Bronchus and lungSecondary malignant neoplasm of lungMalignant neoplasm: Lower lobe, bronchus or lungMalignant neoplasm: Bronchus or lung, unspecifiedMalignant neoplasm of bronchus and lung
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06120140
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06120140 through Pure Global AI's free database. This Phase 2 trial is sponsored by Janssen Research & Development, LLC and is currently Not yet recruiting. The study focuses on Carcinoma, Non-Small-Cell Lung. Target enrollment is 180 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.