Table of contents
- Trial overview
- Who the trial is for
- What is being studied
- Trial phase and design
- Outcomes being measured
- Trial status and size
Trial overview
This study is a Phase 2 interventional trial that is authorised and planned for 80 participants.[1] It focuses on people with first-line locally advanced or metastatic EGFR-mutated non-small cell lung cancer who are treated with amivantamab and lazertinib.[1]
Who the trial is for
The target population includes people with Stage IIIB/C-IV disease, which means cancer that is locally advanced or has spread.[1] The trial is designed for participants starting first-line treatment, meaning this is the first treatment given for their cancer.[1]
What is being studied
The main question is whether enhanced dermatologic management, which means a more active skin care plan, can lower the number of skin side effects compared with standard skin care.[1] The study also includes an amivantamab SC expansion cohort, where researchers estimate skin side effects with a modified enhanced skin care plan and early intervention.[1]
The brief summary says the study compares enhanced dermatologic management with standard-of-care skin management in participants receiving amivantamab and lazertinib.[1] In simple terms, the trial is checking whether closer skin monitoring and earlier treatment of skin problems can help people stay on therapy more comfortably.[1]
Trial phase and design
This is an interventional study, which means researchers are testing a planned care strategy rather than just observing what happens.[1] The trial is open-label, meaning both the study team and participants know which care approach is being used.[1]
The design includes Arms A and B, which compare enhanced dermatologic management with standard-of-care skin management.[1] There is also an amivantamab SC expansion cohort that uses a modified enhanced plan with early intervention.[1]
Outcomes being measured
The primary outcome is the incidence of Grade 2 or higher dermatologic adverse events of interest during the first 12 weeks after treatment begins.[1] Incidence means how often the side effect happens in the study group.[1]
These dermatologic adverse events are skin-related problems that the study team is tracking closely.[1] The trial looks at whether enhanced skin care can reduce these events compared with standard care.[1]
Trial status and size
The trial status is Authorised, which means it has been approved to move forward.[1] The planned enrollment is 80 participants.[1]
The source data list several skin-related interventions used in the study plan, including topical, oral, and cutaneous treatments, but the main research focus is the skin management strategy rather than the individual products themselves.[1]
