NCT06532149

ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer

ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer (EROS)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Although many phase III clinical trials evaluate the quality of life as a secondary endpoint, male sexuality remains a neglected topic in oncology research. In light of the long-term efficacy of new-generation anticancer treatments for ANSCLC (i.e. targeted therapies and immunotherapy), there is a paucity of data about any detrimental effect on fertility and sexuality that could complicate the therapy proposal, especially in young patients. The aim of this trial is to assess incidence of endocrine toxicity and sexual dysfuction in male patients receiving active treatment for ANSCLC

Conditions

• NSCLC Stage IV
• Sex Disorder
• Hypogonadism, Male
• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	Alectinib	Alectinib 600 mg/BID
DRUG	Brigatinib	180 mg/daily
DRUG	Lorlatinib 100 mg	100 mg/daily
DRUG	Osimertinib	80 mg/daily
DRUG	Sotorasib	960 mg/daily
DRUG	Dabrafenib	150 mg/BID
DRUG	Trametinib	2 mg/daily
DRUG	Selpercatinib	160 mg/BID
DRUG	Pembrolizumab	200 mg intravenous every 21 days
DRUG	Cemiplimab	350 mg intravenous every 21 days
DRUG	Nivolumab	240 mg intravenous every 14 days
DRUG	Carboplatin	AUC4/AU5 intravenous every 21 days
DRUG	Pemetrexed	500 mg/mq intravenous every 21 days
DRUG	Paclitaxel	175 mg/mq intravenous every 21 days

Timeline

• Start date: 2024-08-05
• Primary completion: 2026-09-05
• Completion: 2026-09-30
• First posted: 2024-08-01
• Last updated: 2024-08-09

Locations

1 site across 1 country: Italy