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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT06532149
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
MALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Aug 5, 2024
Status verified
Aug 2024
Primary completion
Sep 5, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Cohort A
    Male patients diagnosed with advanced/metastatic ALK+ o ROS-1+ NSCLC, who are receving active anticancer treatment
  • Arm: Cohort B
    Male patients diagnosed with advanced/metastatic oncogene-addicted NSCLC (other than ALK and ROS-1), who are receving active anticancer treatment
  • Arm: Cohort C
    Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving immunotherapy (single agent or combintions without cytotoxic agents)
  • Arm: Cohort D
    Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving chemotherapy alone or in combination with immunotherapy

Primary Outcome Measure

Incidence of treatment-related sexual dysfuction in male patients with ANSCLC [ Time Frame: From treatment start up to 1 year ]

Central Contacts

Related Studies