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

NCT06532149 | Recruiting

• 1 other identifier: 6578
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

NSCLC; Sexual Health; Male hypogonadism; Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of treatment-related hypogonadism in male patients with ANSCLC

  From treatment start up to 1 year

• Incidence of treatment-related erectile dysfuction in male patients with ANSCLC

  From treatment start up to 1 year

Study Arms (4)

Cohort A

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

Drug: Alectinib; Drug: Brigatinib; Drug: Lorlatinib 100 mg

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; Drug: Sotorasib; Drug: Dabrafenib; Drug: Trametinib; Drug: Selpercatinib

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; Drug: Cemiplimab; Drug: Nivolumab

Cohort D

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

Drug: Pembrolizumab; Drug: Cemiplimab; Drug: Nivolumab; Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel

Interventions

Alectinib DRUG

Alectinib 600 mg/BID

Also known as: Alecensa

Cohort A

Brigatinib DRUG

180 mg/daily

Also known as: ALUNBRIG

Cohort A

Lorlatinib 100 mg DRUG

100 mg/daily

Also known as: LORVIQUA

Cohort A

Osimertinib DRUG

80 mg/daily

Cohort B

Sotorasib DRUG

960 mg/daily

Cohort B

Dabrafenib DRUG

150 mg/BID

Cohort B

Trametinib DRUG

2 mg/daily

Cohort B

Selpercatinib DRUG

160 mg/BID

Cohort B

Pembrolizumab DRUG

200 mg intravenous every 21 days

Cohort C; Cohort D

Cemiplimab DRUG

350 mg intravenous every 21 days

Cohort C; Cohort D

Nivolumab DRUG

240 mg intravenous every 14 days

Cohort C; Cohort D

Carboplatin DRUG

AUC4/AU5 intravenous every 21 days

Cohort D

Pemetrexed DRUG

500 mg/mq intravenous every 21 days

Cohort D

Paclitaxel DRUG

175 mg/mq intravenous every 21 days

Cohort D

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma sample for full hormone assessment

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Sexual Dysfunction, Physiological; Eunuchism; Erectile Dysfunction

Interventions

alectinib; brigatinib; lorlatinib; osimertinib; sotorasib; dabrafenib; trametinib; selpercatinib; pembrolizumab; cemiplimab; Nivolumab; Carboplatin; Pemetrexed; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Diseases; Urogenital Diseases; Hypogonadism; Gonadal Disorders; Endocrine System Diseases; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Central Study Contacts

Emilio Bria, MD

CONTACT

0630156318; emilio.bria@policlinicogemelli.it

Emanuele Vita, MD

CONTACT

0630156318; dr.emanuele.vita@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: August 5, 2024
• Primary Completion (Estimated): September 5, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)