When I see a trial for Gastroenteropancreatic NETs (GEPNETs), I know that BP (Bronchopulmonary) NETs (includes Lung) are not included. When you look at the approval wording for the major treatments in use (PRRT Lutathera, Lanreotide), they appear to use the term GEPNETs making BP NETs the poor relative. Clearly there’s highly complex reasons why NETs react differently in different parts of the body. I can see that BP NET patients were involved in clinical trials for both of the mainstream treatments listed above. The drug approval process is also highly complex, and I can see from the wording that functional BP NETs with carcinoid syndrome can qualify at least for somatostatin analogues (Lanreotide and Octreotide). That is not to say BP NET patients cannot get access to these treatments, I see that happening in my group, mainly via clinical trials and other quirks in healthcare systems. And we’re waiting to hear about the results of the SPINET trial for Lung NETs and Lanreotide.
I wish they would settle on the correct terms for Lung Neuroendocrine Neoplasms but that’s another story for another day. It’ll be interesting to see the terms used in the forthcoming Blue Book update due in 2021 for Cancers of the thoracic region and the overall Neuroendocrine Neoplasms version also due for release. Lung terminology using ‘carcinoid‘ is still a loose end.
I was therefore delighted to see this clinical trial which looks at the efficacy of PRRT (Lu177) vs the efficacy of Everolimus (Afinitor). The latter is approved for the treatment of adult patients with progressive, well-differentiated non-functional, neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease (US FDA wording, Europe is similar).
What is this trial?
This phase II trial studies the effect of lutetium Lu 177 dotatate in treating patients with somatostatin receptor positive bronchial neuroendocrine tumors that have spread to other places in the body (advanced). Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and not harm normal cells. Giving lutetium Lu 177 dotatate instead of standard of care everolimus may lower the chances of neuroendocrine tumors growing or spreading.
The primary objective of this trial is to compare progression-free survival (PFS) of receiving lutetium Lu 177 dotatate to that of receiving everolimus in patients with bronchial neuroendocrine tumor (NET). The secondary objectives are to:
I. To compare the overall survival (OS) of receiving lutetium Lu 177 dotatate versus everolimus in patients with bronchial NET.
II. To compare the overall response rate (ORR) associated with lutetium Lu 177 dotatate versus everolimus in patients with bronchial NET.
III. To evaluate and compare the toxicity profile of lutetium Lu 177 dotatate and everolimus.
There are also exploratory objectives which can be found by reading the clinical trials document. Reading between the lines and not wishing to prejudge the outcome of the trial, this could be an opportunity to request BP NETs be added to the authorisation for Lutathera (Lu177 PRRT). This won’t happen overnight; clinical trials need time, and they take time.
When is the trial taking place?
It commences Feb 2021 and completes in July 2024.
Who is eligible?
This is complex and you need to carefully read the exclusion and inclusion criteria including the trial locations. They are only looking for 105 participants, which makes it quite a small trial. Location is also an important factor – the trials document is spartan in detail about location but because it’s a trial sponsored by the US National Cancer Institute (NCI) (NCI), I’m guessing it will be based in Bethesda, Maryland – will try to find out more detail on this. Dr Thomas Hope is the lead investigator, he’s a well-known nuclear radiologist from San Franscico.
Read the clinical trial document – click here
Clinical Trials Disclaimer
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. Inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan.
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