Reviewed and updated 30th July 2024. Phase III trial data update.
Update 30th July 2024.
This trial had a low particpation repsonse. Experts cited the main reason was the increasing use of SSAs for Typical and Atypical Lung NETs in clinical practice; as such, patients were reluctant to enroll in this study, with the risk of receiving a placebo, when they could access the active treatment with a prescription.
The above is unfortunate but perhaps the wording of some approvals caused confusion about scope. Together with pragmatic compassionate use in cliniclal practice this has perhaps had an adverse affect in gaining official approval beyond GEP NETs. But that is only my opinion.
Nontheless, as this new publication suggests…….. “In conclusion, despite lower-than-target enrollment, SPINET is the largest prospective study to date of SSA therapy in SSTR-positive TCs and ACs. The study provides clinically important data about the activity and tolerability profile of LAN 120 mg every 28 days in unresectable and/or metastatic BP-NETs. The results of SPINET thus provide much-needed data to support the clinical use of SSAs in BP-NETs, mainly TCs, as recommended by European and US guidelines.”
You can read the whole report by clicking here. The report has been authored by some big names in the NET world. Whether there is any action behind the scenes to extend the formal approval beyond GEP NETs remains to be seen.
Orginal article
There’s been a lot of action in the area of what is termed Gastro-Entero-Pancreatic Neuroendocrine Tumors (GEP-NETs). It can therefore sometimes appear that Lung NETs are the poor relation. There are certainly some unmet needs in this area of the anatomy including a lack of research.
However, there has been some recent movement. Last year, the use of Afinitor (Everolimus) was approved for progressive, non-functional NET of GI or Lung origin.
In late 2016, I tipped you off about an Ipsen sponsored trial for Lung NETs involving Lanreotide (Somatuline). SPINET is a Phase 3, prospective, multi-center, randomized, double-blind, study evaluating the efficacy and safety of Lanreotide plus “Best Supportive Care” (BSC) versus placebo plus BSC for the treatment of well-differentiated, metastatic and/or unresectable, typical or atypical lung NETs. The aim of the SPINET study is to evaluate the safety and antitumor efficacy of Lanreotide 120 mg in patients with advanced lung NETs. I suspect that many Lung NET patients are already receiving somatostatin analogues (Octreotide/Lanreotide) but prescribed only for syndrome/symptom control.
The countries involved in the SPINET trial are as follows (in case my post goes out of date – see the latest update to the trials document here). Please also check the inclusion and exclusion criteria.
USA, Austria, Canada, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, UK.
In addition to the trial document linked above, you can read more about the SPINET trial here with commentary from a well-known NET Specialist – Dr Diane Reidy-Lagunes, who is the principal investigator for the trial.
Initial Results from Phase III SPINET clinical trial.
“The largest prospective study to date with a SSA in SSTR-positive BP-NETs, suggests that LAN 120 mg could be an appropriate treatment option, especially for TC.”
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided in the clinical trials document. It’s very important to check the trial inclusion and exclusion criteria before making any contact. If you need questions, the articles here is very useful Questions to Ask About Clinical Trials | Cancer.Net
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