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
Share the trial ID with your doctor to see if trial participation is right for you. Participation depends on an independent medical assessment.
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