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Ronny Allan
US Trial
I was delighted to see this clinical trial which looks at the efficacy of PRRT (Lu177 dotatate) 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 compared to the usual treatment (everolimus) 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 may reduce harm to normal cells. Lutetium Lu 177 dotatate may be more effective than everolimus in shrinking or stabilizing advanced bronchial neuroendocrine tumors.
The primary objective of this trial is to I. 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 somatostatin receptor positive Lung NETs be added to the authorisation for Lutathera (Lu177 PRRT). This won’t happen overnight; clinical trials take time.
US Trial Summary
This trial has been in the database since the end of 2020 and I guess it takes time to get going. It’s also possible delays were due to the pandemic.
The trial commenced 3 Feb 2023 and is earmarked to complete in the middle of 2024.
They are looking for 103 participants an the trial locations are spread widely across several states in USA (some states have more than one location available). See clinical trial document below (Contacts and Locations).
Read the US Clinical Trial document here
- ClinicalTrials.gov Identifier NCT04665739: click here to read
The Similar European Trial
A similar trial sponsored by the Spanish NET Specialist (Group GETNE) can be found here. Entitled “Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.”
This trial compares 177Lu-edotreotide (x 6) vs Everolimus for lung and thymic NETs.
They are looking for 120 participants across 25 centres in Europe (only Spain Italy and France are listed). Already recruiting in Spain and very soon in France and Italy. The trial commenced in Oct 2023 and runs until 2028.
Read the clinical trial document by clicking here.
Why is these trials important?
Lung NETs are behind the curve in terms of the numbers of treatments and trials in place for gastroenteropancreatic NETs (GEP-NETs).
General 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. 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
The inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan.
Disclaimer
I am not a doctor or any form of medical professional, practitioner or counsellor. None of the information on my website, or linked to my website(s), or conveyed by me on any social media or presentation, should be interpreted as medical advice given or advised by me.
Neither should any post or comment made by a follower or member of my private group be assumed to be medical advice, even if that person is a healthcare professional.
Please also note that mention of a clinical service, trial/study or therapy does not constitute an endorsement of that service, trial/study or therapy by Ronny Allan, the information is provided for education and awareness purposes and/or related to Ronny Allan’s own patient experience. This element of the disclaimer includes any complementary medicine, non-prescription over the counter drugs and supplements such as vitamins and minerals.
Finally
Whenever I post about a trial or study, some people get excited without understanding that these new treatments and capabilities can very often take years to come to fruition and it’s also possible that clinical trials can be halted, or that national approval agencies will not approve the final product. Plus, not everyone will be eligible, so always check the exclusion and inclusion criteria in the relevant clinical trials document. Please bear that in mind when reading studies/clinical trials posted on RonnyAllan.NET
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nice to see lung nets patients being referred to, so little is being said about us patients with lung nets and the differences there are from nets in other locations .
my pleasure, I have one more to publish!