Prioritizing Patient QOL in EGFR-Mutated NSCLC Treatment
Jill Feldman discusses the background of the phase 2 COCOON trial in advanced non–small cell lung cancer with EGFR mutations.
In an interview discussing the findings from the phase 2 COCOON trial (NCT06120140), lead study author Jill Feldman, co-founder of EGFR Registers, a patient advocacy group in Deerfield, Illinois, highlights the significant impact of the COCOON dermatologic management (DM) prophylactic regimen in mitigating adverse events (AEs) and improving quality of life (QOL) for patients receiving amivantamab-vmjw (Rybrevant) plus lazertinib (Lazcluze) for advanced non–small cell lung cancer (NSCLC) with EGFR mutations.
Findings from the phase 2 COCOON trial were presented in a poster session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Feldman explains that the impetus for the COCOON trial stemmed from recognizing that AEs were a major barrier to treatment adherence in the MARIPOSA regimen. The trial aimed to shift from a reactive to a proactive approach to managing dermatologic toxicities.
"What prompted it was really recognizing that [in] the MARIPOSA regimen, the biggest barrier to treatment was [adverse events]. So finding a way to address [and] mitigate those [adverse events], to prevent them, if you know, if we can," she says. This proactive strategy was designed to prevent or alleviate AEs before they emerged, thereby allowing patients to remain on their crucial treatment.
The COCOON trial enrolled 201 patients with advanced, treatment-naive NSCLC harboring EGFR exon 19 deletions or L858R mutations. These patients were randomly assigned to either standard-of-care (SOC) DM, which typically addresses AEs reactively, or the COCOON DM regimen. The COCOON regimen included a comprehensive prophylactic plan: oral doxycycline or minocycline for 12 weeks, followed by daily topical clindamycin lotion on the scalp for 9 months, daily chlorhexidine on the nails for 12 months, and daily ceramide-based moisturizer on the body and face for 12 months.
A key aspect of the COCOON trial, as emphasized by Feldman, was the focus on patient-reported outcomes (PROs) using tools like Skindex-16 and PGI-S. Feldman argues for the importance of PROs in cancer care: "Too often in cancer, suffering is accepted as part of the deal. I remember asking the question, what if we didn't have to? What if it wasn't part of the deal? What could we change that so? And I think it is very important because it can change not only how well people feel, but it could also allow people to stay on treatment and benefit from that treatment."
She further elaborates, "To measure how well people were living, we use patient-reported outcomes because there is no other reliable data on [adverse events], severity, and impact on daily life. You won't be able to measure that on a lab test or see it on a scan, and so that's why it was really important to ask patients directly, "How is this impacting your life?"
