Study Protocol
Rationale and design of a phase II study to evaluate prophylactic treatment of dacomitinib-induced dermatologic adverse events in epidermal growth factor receptor-mutated advanced non-small cell lung cancer (SPIRAL-Daco study)
Abstract
Background: Dacomitinib is the first second-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) to significantly improve overall survival in the patients of EGFR mutation-positive inoperable or postoperative recurrent non-small cell lung cancer (NSCLC). However, dermatologic adverse events (AEs) increase with dacomitinib treatment, and the management strategy for dermatologic AEs is crucial. In particular, a proactive strategy has become desirable in clinical practice settings. We designed a trial to assess a proactive strategy for dermatologic AEs associated with dacomitinib treatment.
Methods: This is a single-arm, prospective, open-label, multicenter, phase II trial. Patients with advanced NSCLC harboring EGFR-activating mutations will receive dacomitinib and prophylactic treatment as follows: minocycline, skin moisturizer, topical steroid, and sunscreen. Treatment will be continued until progressive disease or any of the discontinuation criteria are met. The primary endpoint is the incidence of dermatologic AEs (≥ grade 2) in the first 8 weeks of dacomitinib treatment. Secondary endpoints are the proportion of dose reduction of dacomitinib, progression-free survival, and safety.
Discussion: We are conducting a phase II study to explore the preventive efficacy of prophylactic medication against dacomitinib-induced dermatologic AEs.
Trial registration: jRCTs071190015.
Methods: This is a single-arm, prospective, open-label, multicenter, phase II trial. Patients with advanced NSCLC harboring EGFR-activating mutations will receive dacomitinib and prophylactic treatment as follows: minocycline, skin moisturizer, topical steroid, and sunscreen. Treatment will be continued until progressive disease or any of the discontinuation criteria are met. The primary endpoint is the incidence of dermatologic AEs (≥ grade 2) in the first 8 weeks of dacomitinib treatment. Secondary endpoints are the proportion of dose reduction of dacomitinib, progression-free survival, and safety.
Discussion: We are conducting a phase II study to explore the preventive efficacy of prophylactic medication against dacomitinib-induced dermatologic AEs.
Trial registration: jRCTs071190015.
