NSCLC Stage IVEROSNCT06532149
ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer
An observational study of NSCLC Stage IV and Sex Disorder, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- NSCLC Stage IV, Sex Disorder, Hypogonadism, Male
- What is being tested?
- Alectinib, Brigatinib and Lorlatinib 100 mg
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 5 Aug 2024to 30 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Sexually active male patients diagnosed with advanced/metastatic NSCLC who are receiving active treatement according to their tumor molecular profiling
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Gemelli IRCCS
Rome, 00168
Emilio Bria, Professor, 0630155202 ext. +39, emilio.bria@policlinicogemelli.it
About this study
Official title: 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
- Conditions
- NSCLC Stage IV, Sex Disorder, Hypogonadism, Male, Erectile Dysfunction
- Being tested
- Alectinib, Brigatinib, Lorlatinib 100 mg, Osimertinib, Sotorasib
- Keywords
- NSCLC, Sexual Health, Male hypogonadism, Erectile Dysfunction
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Sexual Dysfunction, Physiological, Eunuchism, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlectinibDrug
Also called Alecensa
Alectinib 600 mg/BID
BrigatinibDrug
Also called ALUNBRIG
180 mg/daily
Lorlatinib 100 mgDrug
Also called LORVIQUA
100 mg/daily
OsimertinibDrug
80 mg/daily
SotorasibDrug
960 mg/daily
DabrafenibDrug
150 mg/BID
TrametinibDrug
2 mg/daily
SelpercatinibDrug
160 mg/BID
PembrolizumabDrug
200 mg intravenous every 21 days
CemiplimabDrug
350 mg intravenous every 21 days
NivolumabDrug
240 mg intravenous every 14 days
CarboplatinDrug
AUC4/AU5 intravenous every 21 days
PemetrexedDrug
500 mg/mq intravenous every 21 days
PaclitaxelDrug
175 mg/mq intravenous every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Male patients diagnosed with advanced/metastatic ALK+ o ROS-1+ NSCLC, who are receving active anticancer treatment Receives: 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 Receives: 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) Receives: 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 Receives: Drug: Pembrolizumab; Drug: Cemiplimab; Drug: Nivolumab; Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-related sexual dysfuction in male patients with ANSCLC
Percentage of patients who reported any sexual health disorders after treatment start
Measured: From treatment start up to 1 year
Secondary outcomes (2)
Incidence of treatment-related hypogonadism in male patients with ANSCLC
Percentage of patients who reported reduction of testosterone levels after treatment start
Measured: 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
Measured: From treatment start up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start5 Aug 2024 (estimated)
- Primary completion5 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IVStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bria Emilio, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532149
- Sponsor's protocol ID
- 6578
- Acronym
- EROS
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer (EROS)
- ClinicalTrials.gov ID
- NCT06532149
- Acronym / sponsor ID
- EROS / 6578
- Conditions
- NSCLC Stage IV, Sex Disorder, Hypogonadism, Male, Erectile Dysfunction
- Keywords
- NSCLC, Sexual Health, Male hypogonadism, Erectile Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 5 Aug 2024 (estimated)
- Primary completion
- 5 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Drug: Alectinib, Drug: Brigatinib, Drug: Lorlatinib 100 mgMale patients diagnosed with advanced/metastatic ALK+ o ROS-1+ NSCLC, who are receving active anticancer treatment |
| Cohort B | – | Drug: Osimertinib, Drug: Sotorasib, Drug: Dabrafenib, Drug: Trametinib, Drug: SelpercatinibMale patients diagnosed with advanced/metastatic oncogene-addicted NSCLC (other than ALK and ROS-1), who are receving active anticancer treatment |
| Cohort C | – | Drug: Pembrolizumab, Drug: Cemiplimab, Drug: NivolumabMale patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving immunotherapy (single agent or combintions without cytotoxic agents) |
| Cohort D | – | Drug: Pembrolizumab, Drug: Cemiplimab, Drug: Nivolumab, Drug: Carboplatin, Drug: Pemetrexed, Drug: PaclitaxelMale patients diagnosed with advanced/metastatic non oncogene-addicted NSCLC, who are receving chemotherapy alone or in combination with immunotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sexually active male patients diagnosed with advanced/metastatic NSCLC who are receiving active treatement according to their tumor molecular profiling
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlectinibAlso: AlecensaAlectinib 600 mg/BID | Drug | Cohort A |
| BrigatinibAlso: ALUNBRIG180 mg/daily | Drug | Cohort A |
| Lorlatinib 100 mgAlso: LORVIQUA100 mg/daily | Drug | Cohort A |
| Osimertinib80 mg/daily | Drug | Cohort B |
| Sotorasib960 mg/daily | Drug | Cohort B |
| Dabrafenib150 mg/BID | Drug | Cohort B |
| Trametinib2 mg/daily | Drug | Cohort B |
| Selpercatinib160 mg/BID | Drug | Cohort B |
| Pembrolizumab200 mg intravenous every 21 days | Drug | Cohort C, Cohort D |
| Cemiplimab350 mg intravenous every 21 days | Drug | Cohort C, Cohort D |
| Nivolumab240 mg intravenous every 14 days | Drug | Cohort C, Cohort D |
| CarboplatinAUC4/AU5 intravenous every 21 days | Drug | Cohort D |
| Pemetrexed500 mg/mq intravenous every 21 days | Drug | Cohort D |
| Paclitaxel175 mg/mq intravenous every 21 days | Drug | Cohort D |
Primary outcome
Incidence of treatment-related sexual dysfuction in male patients with ANSCLC
Time frame: From treatment start up to 1 year
Percentage of patients who reported any sexual health disorders after treatment start
2 secondary outcomes
Incidence of treatment-related hypogonadism in male patients with ANSCLC
Time frame: From treatment start up to 1 year
Incidence of treatment-related erectile dysfuction in male patients with ANSCLC
Time frame: From treatment start up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC Stage IV and Sex Disorder, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilio Bria, MD (0630156318, emilio.bria@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-related sexual dysfuction in male patients with ANSCLC (time frame: From treatment start up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.