Clinical trial · Observational
Alectinib-induced Endocrine Toxicity
Alectinib-induced Endocrine Toxicity in Patients With ALK-positive Advanced NSCLC: an Onservational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The experimental Cohort A (male ALK+ ANSCLC patients receiving alectinib), the control Cohort B (female ALK+ ANSCLC patients receiving alectinib) and control Cohort C (male NON-ALK ANSCLC patients) were prospectively evaluated for full hormone assessment of androgen deficiency, AT 8 weeks after treatment start and in case of reported suspected symptoms. Patients with major sexual dysfunctions were referred to endocrinologist.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC Stage IV | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alectinib 150 MG [Alecensa] | Drug | Alectinib | ALIAS |
Design
Arms and outcomes
Arms (3)
- label
- Cohort A
- description
- Male ALK-positive ANSCLC patients receiving first-line treatment with alectinib
- interventionNames
- Drug: Alectinib 150 MG [Alecensa]
- label
- Cohort B
- description
- Female ALK-positive ANSCLC patients receiving first-line treatment with alectinib
- interventionNames
- Drug: Alectinib 150 MG [Alecensa]
- label
- Cohort C
- description
- Male ALK-negative ANSCLC patients receiving first-line treatment according to molecular profiling
Primary outcomes (2)
- measure
- Incidence of endocrine toxicity in overall ALK-positive
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed advanced NSCLC (ANSCLC) For ALK+ NSCLC (Cohorts A-B) 1a. ALK-rearrangement confirmed by NGS and/or VENTANA ALK (D5F3) immunoistochemical assay 1b. Treatment naïve patients candidate to treatment with alectinib oral at standard dose of 600 mg twice daily 2. Patient aged 18 to 70 years 3. To be sexually active at time of enrolment 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 5. Written informed consent Exclusion Criteria: 1. History of endocrine disorders, excepting for controlled hypothyroidism (surgical or non-surgical) treated with replacement levothyroxine since at least 2 years 2. Any cancer-related or medical condition that would interfere with the patient reported outcomes or laboratory assessment. Examples include, but are not limited to: 2a. 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) 2b. History of chronic liver disease or hormonal replacement therapy (e.g. ADT for prostatic cancer) 2c. Participants who not adequately recovered from previous confirmed chemotherapy-induced gonadotoxicity (e.g. cisplatin) 2d. 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 2e. Psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study 2f. 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
References
Publications (0)
Data not yet available