Table of Contents
- Trial overview
- Who can participate
- Trial phases and study goals
- Main endpoints and what they mean
- Trial statuses and enrollment
- Study treatments used with Lysine Hydrochloride
Trial overview
The available trial data show that Lysine Hydrochloride is being used in several interventional studies across different diseases.[1][2][3][4][5] These studies include cancer trials in children and adults, plus one study in chronic hemodialysis patients.[1][2][3][4][5]
The trials are investigating different questions, such as safety, dose finding, treatment effect, and disease control.[1][4][5] In the source data, Lysine Hydrochloride appears in the intervention list as LysaKare in several studies.[1][2][4][5]
Who can participate
One study includes children with recurrent or refractory neuroblastoma, which means the cancer came back or did not respond well to earlier treatment.[1] Another study includes adults with gastroenteropancreatic neuroendocrine tumours, called GEP-NETs, and focuses on patients with dominant liver metastases, meaning the main tumor spread is in the liver.[2]
Another large study includes adults with grade 1 and grade 2 advanced GEP-NET.[4] One trial includes people with extensive stage small cell lung cancer, which is a fast-growing lung cancer that has spread widely.[5] One study is not a cancer trial and instead includes patients on chronic hemodialysis who are being studied for muscle protein turnover.[3]
Trial phases and study goals
The studies range from Phase 1 to Phase 3.[1][2][3][4][5] Phase 1 trials mainly study safety and dose, while Phase 2 and Phase 3 trials look more closely at whether the treatment helps patients.[1][2][4][5]
In the child neuroblastoma study, the main goal is to find the Maximum Tolerated Dose of 177Lu-DOTATATE.[1] In the GEP-NET liver metastasis study, the main goal is to measure tracer uptake on PET scans after intra-hepatic injection and compare it with intravenous treatment.[2]
In the hemodialysis study, the goal is to study the effect of IDPN on muscle protein synthesis and to describe hemodynamic effects, which means changes in blood flow or circulation during treatment.[3] In the NETTER-3 study, the goal is to show whether [177Lu]Lu-DOTA-TATE plus octreotide LAR delays disease progression or death better than the control treatment.[4] In the small cell lung cancer study, Phase Ib is for dose finding and safety, and Phase II is for overall survival comparison.[5]
Main endpoints and what they mean
The main endpoint in the neuroblastoma study is the Maximum Tolerated Dose (MTD), and the study also tracks dose limiting toxicities (DLTs) during the first 6 weeks after the first injection.[1] DLTs are side effects serious enough to limit treatment.[1]
The GEP-NET liver metastasis study measures 68Ga-DOTA-peptides uptake on PET scans, reported as Maximum Standardized Uptake Value or SUVmax, in up to 5 liver metastases.[2] This tells researchers how strongly the lesions take up the tracer after different ways of giving the radiolabeled treatment.[2]
The hemodialysis study measures the difference in myofibrillar fractional synthetic rate during one week of IDPN versus control.[3] This is a way to measure how fast muscle protein is being made.[3]
The NETTER-3 study uses progression-free survival (PFS) as the main endpoint.[4] PFS means the time from randomization until the cancer gets worse or the patient dies from any cause.[4]
The small cell lung cancer study measures dose limiting toxicities, adverse events, serious adverse events, treatment discontinuation, and later overall survival (OS).[5] OS means the time from randomization until death from any cause.[5]
Trial statuses and enrollment
One trial is marked Completed, while the others are marked Authorised.[1][2][3][4][5] Enrollment sizes are small in the early studies and larger in the later trials, ranging from 18 participants to 241 participants.[1][2][3][4][5]
NCT03966651 enrolled 18 children and is completed.[1]
NCT04837885 enrolled 23 adults and is authorised.[2]
2025-522111-42-02 enrolled 20 hemodialysis patients and is authorised.[3]
2024-518325-15-00 enrolled 241 participants and is authorised.[4]
NCT05142696 enrolled 138 participants and is authorised.[5]
Study treatments used with Lysine Hydrochloride
In the source data, Lysine Hydrochloride is listed as LysaKare in multiple studies, often together with radiolabeled somatostatin analog treatment such as Lutathera.[1][2][4][5] The studies also include other trial medicines and procedures, such as octreotide, carboplatin, etoposide, atezolizumab, PET scans, and intra-arterial or intravenous administration methods, depending on the trial.[2][4][5]
These trials do not study Lysine Hydrochloride by itself as a stand-alone treatment in the source data.[1][2][4][5] Instead, it appears as part of a treatment plan being tested in different patient groups.[1][2][4][5]
