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

Recruiting

• Conditions: Hypogonadism, Male; NSCLC Stage IV; Sex Disorder; Erectile Dysfunction
• Interventions: Drug: Alectinib; Drug: Osimertinib; Drug: Pembrolizumab; Drug: Cemiplimab; Drug: Brigatinib; Drug: Sotorasib; Drug: Lorlatinib 100 mg; Drug: Dabrafenib; Drug: Nivolumab; Drug: Trametinib; Drug: Carboplatin; Drug: Pemetrexed; Drug: Selpercatinib; Drug: Paclitaxel

• Registration Number: NCT06532149
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-29
• Study First Submitted QC: 2024-07-29
• Status Verified: 2024-08
• Study First Posted: 2024-08-01
• Study Start: 2024-08-05
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-09
• Primary Completion: 2026-09-05
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

• Diagnosis of advanced/metastatic NSCLC
• To be candidate to active treatment
• Aged ≥ 18 anni (up to 75 years old)
• To be sexually active in last 30 days before treatment start
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Written informed consent

Exclusion Criteria

• History of endocrine disorders, excepting for controlled hypothyroidism (surgical or non-surgical) treated with replacement levothyroxine since at least 2 years

• Any cancer-related or medical condition that would interfere with the patient reported outcomes or laboratory assessment. Examples include, but are not limited to:

• Cancer-related conditions that may preclude/undermine sexual activity (e.g. leptomeningeal carcinomatosis, pathological vertebral fractures, gonadic metastases, unstable spinal cord compression, uncontrolled neurological symptoms, surgical complications):

  • History of chronic liver disease or hormonal replacement therapy (e.g. ADT for prostatic cancer)
  • Participants who not adequately recovered from previous confirmed chemotherapy-induced gonadotoxicity (e.g. cisplatin)
  • Chronic use of drugs with known effect on male sexuality, including opiates, anxiolytics, antidepressants, mood stabilizers, beta blockers (e.g. atenolol) and high dose diuretics
  • Psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
  • Major psychological disorder and/or high distress level that would interfere with sexual function and the participant's ability to cooperate with the requirements of the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort D	Paclitaxel	Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving chemotherapy alone or in combination with immunotherapy
Cohort A	Lorlatinib 100 mg	Male patients diagnosed with advanced/metastatic ALK+ o ROS-1+ NSCLC, who are receving active anticancer treatment
Cohort B	Dabrafenib	Male patients diagnosed with advanced/metastatic oncogene-addicted NSCLC (other than ALK and ROS-1), who are receving active anticancer treatment
Cohort C	Cemiplimab	Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving immunotherapy (single agent or combintions without cytotoxic agents)
Cohort D	Pemetrexed	Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving chemotherapy alone or in combination with immunotherapy
Cohort A	Brigatinib	Male patients diagnosed with advanced/metastatic ALK+ o ROS-1+ NSCLC, who are receving active anticancer treatment
Cohort B	Selpercatinib	Male patients diagnosed with advanced/metastatic oncogene-addicted NSCLC (other than ALK and ROS-1), who are receving active anticancer treatment
Cohort A	Alectinib	Male patients diagnosed with advanced/metastatic ALK+ o ROS-1+ NSCLC, who are receving active anticancer treatment
Cohort B	Osimertinib	Male patients diagnosed with advanced/metastatic oncogene-addicted NSCLC (other than ALK and ROS-1), who are receving active anticancer treatment
Cohort B	Sotorasib	Male patients diagnosed with advanced/metastatic oncogene-addicted NSCLC (other than ALK and ROS-1), who are receving active anticancer treatment
Cohort B	Trametinib	Male patients diagnosed with advanced/metastatic oncogene-addicted NSCLC (other than ALK and ROS-1), who are receving active anticancer treatment
Cohort C	Pembrolizumab	Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving immunotherapy (single agent or combintions without cytotoxic agents)
Cohort C	Nivolumab	Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving immunotherapy (single agent or combintions without cytotoxic agents)
Cohort D	Pembrolizumab	Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving chemotherapy alone or in combination with immunotherapy
Cohort D	Cemiplimab	Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving chemotherapy alone or in combination with immunotherapy
Cohort D	Nivolumab	Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving chemotherapy alone or in combination with immunotherapy
Cohort D	Carboplatin	Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving chemotherapy alone or in combination with immunotherapy

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-related sexual dysfuction in male patients with ANSCLC	From treatment start up to 1 year	Percentage of patients who reported any sexual health disorders after treatment start

Secondary Outcome Measures

Name	Time	Method
Incidence of treatment-related erectile dysfuction in male patients with ANSCLC	From treatment start up to 1 year	Percentage of patients who erectile dysfuction after treatment start
Incidence of treatment-related hypogonadism in male patients with ANSCLC	From treatment start up to 1 year	Percentage of patients who reported reduction of testosterone levels after treatment start

Trial Locations

Locations (1)

Fondazione Policlinico Gemelli IRCCS; 🇮🇹 Rome, Italy