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

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

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

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Emilio Bria, MD; Phone Number: 0630156318; Email: emilio.bria@policlinicogemelli.it
• Study Contact Backup: Name: Emanuele Vita, MD; Phone Number: 0630156318; Email: dr.emanuele.vita@gmail.com

Study Locations

• Italy
  • Rome, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Gemelli IRCCS
    • Contact: Emilio Bria, Professor; Phone Number: +39 0630155202; Email: emilio.bria@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Sexually active male patients diagnosed with advanced/metastatic NSCLC who are receiving active treatement according to their tumor molecular profiling

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A; Male patients diagnosed with advanced/metastatic ALK+ o ROS-1+ NSCLC, who are receving active anticancer treatment	Drug: Alectinib; Alectinib 600 mg/BID; Other Names: Alecensa; Drug: Brigatinib; 180 mg/daily; Other Names: ALUNBRIG; Drug: Lorlatinib 100 mg; 100 mg/daily; Other Names: LORVIQUA
Cohort B; Male patients diagnosed with advanced/metastatic oncogene-addicted NSCLC (other than ALK and ROS-1), who are receving active anticancer treatment	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
Cohort C; Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving immunotherapy (single agent or combintions without cytotoxic agents)	Drug: Pembrolizumab; 200 mg intravenous every 21 days; Drug: Cemiplimab; 350 mg intravenous every 21 days; Drug: Nivolumab; 240 mg intravenous every 14 days
Cohort D; Male patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving chemotherapy alone or in combination with immunotherapy	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): August 5, 2024
• Primary Completion (Estimated): September 5, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: NSCLC; Erectile Dysfunction; Sexual Health; Male hypogonadism
• Additional Relevant MeSH Terms: Mental Disorders; Endocrine System Diseases; Gonadal Disorders; Sexual Dysfunctions, Psychological; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Erectile Dysfunction; Hypogonadism; Sexual Dysfunction, Physiological; Eunuchism; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Protein Kinase Inhibitors; Immune Checkpoint Inhibitors; Folic Acid Antagonists; Tyrosine Kinase Inhibitors; Carboplatin; Nivolumab; Osimertinib; Pembrolizumab; Pemetrexed; Trametinib; Dabrafenib; Cemiplimab; Sotorasib; Alectinib
• Other Study ID Numbers: 6578

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No