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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Erectile Dysfunction; NSCLC Stage IV; Sex Disorder; Hypogonadism, Male

Treatments: Drug: Alectinib; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Trametinib; Drug: Carboplatin; Drug: Selpercatinib; Drug: Brigatinib; Drug: Nivolumab; Drug: Cemiplimab; Drug: Lorlatinib 100 mg; Drug: Sotorasib; Drug: Pembrolizumab; Drug: Dabrafenib; Drug: Osimertinib

Study type: Observational

Funder types: Other

Identifiers

NCT06532149

6578

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 4 patient groups

Cohort A

Description:

Male patients diagnosed with advanced/metastatic ALK+ o ROS-1+ NSCLC, who are receving active anticancer treatment

Treatment:

Drug: Lorlatinib 100 mg

Drug: Brigatinib

Drug: Alectinib

Cohort B

Description:

Male patients diagnosed with advanced/metastatic oncogene-addicted NSCLC (other than ALK and ROS-1), who are receving active anticancer treatment

Treatment:

Drug: Osimertinib

Drug: Dabrafenib

Drug: Sotorasib

Drug: Selpercatinib

Drug: Trametinib

Cohort C

Description:

Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving immunotherapy (single agent or combintions without cytotoxic agents)

Treatment:

Drug: Pembrolizumab

Drug: Cemiplimab

Drug: Nivolumab

Cohort D

Description:

Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving chemotherapy alone or in combination with immunotherapy

Treatment:

Drug: Pembrolizumab

Drug: Cemiplimab

Drug: Nivolumab

Drug: Carboplatin

Drug: Pemetrexed

Drug: Paclitaxel