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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

Carcinoma, Non-Small-Cell Lung
Clinicaltrials.gov:
EU CTIS:
#2023-505863-35-00
Other:
#61186372NSC2007
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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

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.

Primary outcome measures

  • 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

Secondary outcome measures

  • Number of Participants With DAEIs by Severity Based on NCI-CTCAE v 5.0
  • Number of Participants With Grade >=2 DAEIs Within 6 Months After Initiation of Anticancer Treatment Based on NCI-CTCAE v 5.0
  • Number of Grade >= 2 DAEI Per Participants
  • Time to First Occurrence of Grade >=2 DAEI
  • Time to Resolution of Grade >= 2 DAEI
  • Number of Participants With Paronychia by Severity Based on NCI-CTCAE v 5.0
  • Number of Participants With Scalp Rash by Severity Based on NCI-CTCAE v 5.0
  • Change From Baseline in Skindex Symptoms Domain Score up to 12 Months
  • Change From Baseline in Patient's Global Impression-Severity (PGI-S) Rash up to 12 Months
  • Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Score up to 12 Months
  • Change From Baseline in EuroQol 5 - Dimension (EQ-5D) Patient-reported Outcome (PRO) up to 12 Months (for Amivantamab Subcutaneous Expansion Cohort Only)
  • Percentage of Participants With Dose Reductions, Dose Interruptions, and Dose Discontinuations of Anticancer Treatment due to DAEIs
  • Relative Dose Intensity (RDI) of Anticancer Treatment
  • Percentage of Participants With Venous Thromboembolism (VTE) Adverse Events (AEs) by Severity Based on NCI-CTCAE v 5.0
  • Percentage of Participants With Adverse Events (AEs) by Severity Based on NCI-CTCAE v 5.0
  • Progression Free Survival (PFS)
  • Overall Response Rate (ORR)
  • Duration of Response (DoR)
  • Amivantamab SC Expansion Cohorts: Number of Participants With Grade >= 2 DAEIs Within 12 Weeks After Initiation of Anticancer Treatment
  • Amivantamab SC Expansion Cohorts: Percentage of Participants With an Improvement in DAEI After Starting Early Intervention
  • Amivantamab SC Expansion Cohorts: Time to Improvement of DAEIs After Starting Early Intervention
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