The COCOON Study Design and Baseline Characteristics
Panelists discuss how the COCOON study randomly assigned patients to either standard care or proactive dermatologic management using prophylactic antibiotics, topical treatments, skin moisturization, and anticoagulation to reduce grade 2 or higher dermatologic adverse events.
The COCOON study represents a groundbreaking randomized phase 3 trial designed to evaluate proactive dermatologic management in reducing grade 2 or higher dermatologic adverse events compared with standard care in patients with locally advanced or metastatic EGFR-mutated lung cancer receiving first-line amivantamab plus lazertinib. This innovative study addressed a critical gap in supportive care for targeted therapy patients by implementing prophylactic rather than reactive management strategies.
The study randomly assigned 199 patients 1:1 to either standard dermatologic care or the comprehensive COCOON regimen. The intervention included prophylactic oral antibiotics (doxycycline or minocycline) for the first 12 weeks, followed by topical clindamycin to the scalp from week 13 onward. Additional components included paronychia prophylaxis with 4% chlorhexidine on nails daily, skin moisturization with ceramide-containing, alcohol-free, fragrance-free moisturizers, and mandatory prophylactic anticoagulation for the first four months of treatment.
Baseline characteristics showed a median age of 63 years, with 59% female patients, representing a typical EGFR-mutated non–small cell lung cancer population. The primary end point focused on incidence of grade 2 or higher dermatologic adverse events within the first 12 weeks of anticancer treatment. The interim analysis in November 2024 demonstrated early success, with the median follow-up of 7.1 months showing 77% of patients remaining on their cancer treatments at clinical cutoff, indicating good overall tolerability of both the cancer therapy and supportive care interventions.
