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

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

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-05

Primary Completion

2026-09-05

Completion

2026-09-30

Countries

• Italy

Study Locations