An observational study in NSCLC Stage IV, Sex Disorder and Hypogonadism, Male, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 80 is below the median of 160 across 1,148 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Sexually active male patients diagnosed with advanced/metastatic NSCLC who are receiving active treatement according to their tumor molecular profiling
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Cancer-related conditions that may preclude/undermine sexual activity (e.g. , pathological vertebral fractures, gonadic , unstable spinal cord compression, uncontrolled neurological symptoms, surgical complications):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
Alectinib 600 mg/BID
Also known as: Alecensa
180 mg/daily
Also known as: ALUNBRIG
100 mg/daily
Also known as: LORVIQUA
80 mg/daily
960 mg/daily
150 mg/BID
2 mg/daily
160 mg/BID
200 mg intravenous every 21 days
350 mg intravenous every 21 days
240 mg intravenous every 14 days
AUC4/AU5 intravenous every 21 days
500 mg/mq intravenous every 21 days
175 mg/mq intravenous every 21 days
Incidence of treatment-related sexual dysfuction in male patients with ANSCLC
Percentage of patients who reported any sexual health disorders after treatment start
Time frame: From treatment start up to 1 year
Incidence of treatment-related hypogonadism in male patients with ANSCLC
Percentage of patients who reported reduction of testosterone levels after treatment start
Time frame: 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
Time frame: From treatment start up to 1 year
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2024; primary completion for Sep 2026, 25 months later.
Of 355 non-industry observational studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 126. This study's planned 25 months is below that.
Counting every sponsor, half of 497 studies reached it within 55 months; a quarter within 35 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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