In short
Clinical trials of ZINC GLUCONATE are being studied as part of skin care plans in people with first-line EGFR-mutated advanced or metastatic non-small cell lung cancer. These trials look at whether enhanced dermatologic management can lower skin side effects during amivantamab and lazertinib treatment. They focus on safety and the number of skin problems in the first 12 weeks.
Key points
- Clinical trial data for ZINC GLUCONATE are tied to skin care management in people with first-line EGFR-mutated advanced or metastatic non-small cell lung cancer. The study is a Phase 2 interventional trial and includes 80 planned participants. It compares enhanced dermatologic management with standard skin care, and also studies a modified early-intervention approach in one cohort. The main measure is the number of Grade 2 or higher skin side effects in the first 12 weeks after treatment begins. The trial is authorised and focuses on people receiving amivantamab and lazertinib.
Trial overview
This study is a Phase 2 interventional trial that is authorised and planned for 80 participants. 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.
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. The trial is designed for participants starting first-line treatment, meaning this is the first treatment given for their cancer.
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. 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.
The brief summary says the study compares enhanced dermatologic management with standard-of-care skin management in participants receiving amivantamab and lazertinib. 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.
Trial phase and design
This is an interventional study, which means researchers are testing a planned care strategy rather than just observing what happens. The trial is open-label, meaning both the study team and participants know which care approach is being used.
The design includes Arms A and B, which compare enhanced dermatologic management with standard-of-care skin management. There is also an amivantamab SC expansion cohort that uses a modified enhanced plan with early intervention.
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. Incidence means how often the side effect happens in the study group.
These dermatologic adverse events are skin-related problems that the study team is tracking closely. The trial looks at whether enhanced skin care can reduce these events compared with standard care.
Trial status and size
The trial status is Authorised, which means it has been approved to move forward. The planned enrollment is 80 participants.
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.