{"ok":true,"data":{"subject":{"kind":"trial","nctId":"NCT05773274","title":"Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial","sponsor":"National Cancer Institute (NCI)","phases":["PHASE2"],"status":"RECRUITING","indication":null,"disease":"digestive system mixed adenoneuroendocrine carcinoma"},"rows":[{"n":1,"question":"Is the biology right?","flags":[{"id":"somatic_driver","label":"Somatic driver evidence","value":"no","detail":"None of KDR, MET, FKBP1A, SSTR5, SSTR2, SSTR4, CSF1R, KIT, FLT3 has somatic-mutation evidence in digestive system mixed adenoneuroendocrine carcinoma","rule":"Open Targets has somatic-mutation evidence for the target in this cancer","source":{"label":"Open Targets: KDR in digestive system mixed adenoneuroendocrine carcinoma","url":"https://platform.opentargets.org/evidence/ENSG00000128052/MONDO_0006182","date":"2026-11-11T23:19:59.719Z"},"context":[]},{"id":"human_genetic","label":"Human genetic evidence","value":"no","detail":"No germline or somatic evidence for KDR, MET, FKBP1A, SSTR5, SSTR2, SSTR4, CSF1R, KIT, FLT3 in digestive system mixed adenoneuroendocrine carcinoma","rule":"Any germline or somatic human genetic evidence for the target in this cancer, counted apart from animal-model and literature evidence","source":{"label":"Open Targets: KDR in digestive system mixed adenoneuroendocrine carcinoma","url":"https://platform.opentargets.org/evidence/ENSG00000128052/MONDO_0006182","date":"2026-11-11T23:19:59.719Z"},"context":[]},{"id":"pediatric_target","label":"Pediatric target","value":"yes","detail":"MET, CSF1R, KIT, FLT3 on the FDA list","rule":"Target is on FDA's Pediatric Molecular Target List (relevant targets); membership alone neither requires nor waives a study","source":{"label":"FDA Pediatric Molecular Target List (Listed as February 2026 on the FDA Pediatric Oncology page; the file served is 9.7.22_the_relevant_molecular_target_list.xlsx, whose Summary of Changes sheet is headed 'SEPTEMBER 2022 UPDATE' (footnote date 2022-09-01))","url":"https://www.fda.gov/media/191157/download?attachment","date":"2026-11-11T07:05:03Z"},"context":[]},{"id":"haematologic","label":"Haematologic cancer","value":"no","detail":"Solid tumour","rule":"From the indication, or the registry conditions when no indication matches","source":{"label":"ClinicalTrials.gov NCT05773274","url":"https://clinicaltrials.gov/study/NCT05773274","date":"2026-11-11T23:19:59.719Z"},"context":[{"figure":"Likelihood of approval from phase 1: 7.5% haematologic vs 4.6% solid","dataset":"BIO / Informa / QLS 2021","years":"2011–2020","caveat":"Population-level, not a prediction."}]}],"facts":[{"label":"KDR (via Cabozantinib)","text":"Evidence types in digestive system mixed adenoneuroendocrine carcinoma: literature; literature listed separately from human genetics. Datasources: europepmc.","source":{"label":"Open Targets: KDR in digestive system mixed adenoneuroendocrine carcinoma","url":"https://platform.opentargets.org/evidence/ENSG00000128052/MONDO_0006182","date":"2026-11-11T23:19:59.719Z"}},{"label":"MET (via Cabozantinib)","text":"Open Targets has no association between MET and digestive system mixed adenoneuroendocrine carcinoma.","source":{"label":"Open Targets: MET in digestive system mixed adenoneuroendocrine carcinoma","url":"https://platform.opentargets.org/evidence/ENSG00000105976/MONDO_0006182","date":"2026-11-11T23:19:59.719Z"}},{"label":"FKBP1A (via Everolimus)","text":"Open Targets has no association between FKBP1A and digestive system mixed adenoneuroendocrine carcinoma.","source":{"label":"Open Targets: FKBP1A in digestive system mixed adenoneuroendocrine carcinoma","url":"https://platform.opentargets.org/evidence/ENSG00000088832/MONDO_0006182","date":"2026-11-11T23:19:59.719Z"}},{"label":"SSTR5 (via Lutetium Lu 177 Dotatate)","text":"Open Targets has no association between SSTR5 and digestive system mixed adenoneuroendocrine carcinoma.","source":{"label":"Open Targets: SSTR5 in digestive system mixed adenoneuroendocrine carcinoma","url":"https://platform.opentargets.org/evidence/ENSG00000162009/MONDO_0006182","date":"2026-11-11T23:19:59.719Z"}},{"label":"SSTR2 (via Lutetium Lu 177 Dotatate)","text":"Evidence types in digestive system mixed adenoneuroendocrine carcinoma: literature; literature listed separately from human genetics. Datasources: europepmc.","source":{"label":"Open Targets: SSTR2 in digestive system mixed adenoneuroendocrine carcinoma","url":"https://platform.opentargets.org/evidence/ENSG00000180616/MONDO_0006182","date":"2026-11-11T23:19:59.719Z"}},{"label":"SSTR4 (via Lutetium Lu 177 Dotatate)","text":"Open Targets has no association between SSTR4 and digestive system mixed adenoneuroendocrine carcinoma.","source":{"label":"Open Targets: SSTR4 in digestive system mixed adenoneuroendocrine carcinoma","url":"https://platform.opentargets.org/evidence/ENSG00000132671/MONDO_0006182","date":"2026-11-11T23:19:59.719Z"}},{"label":"CSF1R (via Sunitinib)","text":"Open Targets has no association between CSF1R and digestive system mixed adenoneuroendocrine carcinoma.","source":{"label":"Open Targets: CSF1R in digestive system mixed adenoneuroendocrine carcinoma","url":"https://platform.opentargets.org/evidence/ENSG00000182578/MONDO_0006182","date":"2026-11-11T23:19:59.719Z"}},{"label":"KIT (via Sunitinib)","text":"Open Targets has no association between KIT and digestive system mixed adenoneuroendocrine carcinoma.","source":{"label":"Open Targets: KIT in digestive system mixed adenoneuroendocrine carcinoma","url":"https://platform.opentargets.org/evidence/ENSG00000157404/MONDO_0006182","date":"2026-11-11T23:19:59.719Z"}},{"label":"FLT3 (via Sunitinib)","text":"Open Targets has no association between FLT3 and digestive system mixed adenoneuroendocrine carcinoma.","source":{"label":"Open Targets: FLT3 in digestive system mixed adenoneuroendocrine carcinoma","url":"https://platform.opentargets.org/evidence/ENSG00000122025/MONDO_0006182","date":"2026-11-11T23:19:59.719Z"}}],"pending":[{"what":"Normal-tissue expression in vital organs","source":"Human Protein Atlas (ticket 36)"},{"what":"Pan-essential in cell lines","source":"DepMap (ticket 36)"},{"what":"Approved drug on this target","source":"Drugs@FDA (ticket 30)"}]},{"n":2,"question":"Can the result be trusted?","flags":[{"id":"randomised","label":"Randomised","value":"yes","detail":"Randomised allocation","rule":"Registry allocation field","source":{"label":"ClinicalTrials.gov NCT05773274","url":"https://clinicaltrials.gov/study/NCT05773274","date":"2026-11-11T23:19:59.719Z"},"context":[]},{"id":"small_denominator","label":"Small denominator","value":"no","detail":"100 planned; each patient moves a rate by 100 ÷ 100 = 1.0 points","rule":"Enrolment under 30; the arithmetic is shown, not a benchmark","source":{"label":"ClinicalTrials.gov NCT05773274","url":"https://clinicaltrials.gov/study/NCT05773274","date":"2026-11-11T23:19:59.719Z"},"context":[]},{"id":"primary_os","label":"Primary endpoint is overall survival","value":"no","detail":"Progression-free survival (PFS)","rule":"A registered primary outcome measure names overall survival","source":{"label":"ClinicalTrials.gov NCT05773274","url":"https://clinicaltrials.gov/study/NCT05773274","date":"2026-11-11T23:19:59.719Z"},"context":[{"figure":"Non-OS primary endpoint: odds ratio 2.79 for a positive phase 3","dataset":"Otsuka 2021, 400 phase 3 oncology trials","years":"to 2020","caveat":"Shown with the next figure: a surrogate is easier to hit, and often a weak guide to survival."},{"figure":"52% of surrogate-to-OS correlations are low","dataset":"Prasad 2015","years":"published to 2014","caveat":"Shown with the figure above."}]},{"id":"results_overdue","label":"Results overdue","value":"no","detail":"Primary completion expected 2029-04-30; not yet due","rule":"Primary completion (actual) more than 12 months ago and no results posted to the registry","source":{"label":"ClinicalTrials.gov NCT05773274","url":"https://clinicaltrials.gov/study/NCT05773274","date":"2026-11-11T23:19:59.719Z"},"context":[]}],"facts":[],"pending":[{"what":"Treated and evaluable counts, assessor, confirmed response, follow-up and data cutoff","source":"Readout extraction (ticket 32)"},{"what":"Primary endpoint changed between registry versions","source":"Registry versions in the store (ticket 32)"}]},{"n":3,"question":"What must it beat?","flags":[],"facts":[],"pending":[{"what":"Control-arm result and approved therapies for the same segment, with label links","source":"Drugs@FDA, FDA labels and readouts (tickets 30, 32)"}]},{"n":4,"question":"Too crowded, or too late?","flags":[],"facts":[{"label":"Stopped on this target","text":"382 terminated, withdrawn or suspended trials of drugs against KDR; 11 of the 200 most recent give no reason. Reasons are quoted as the registry gives them on the target page.","source":{"label":"KDR: what already stopped","url":"/target/ENSG00000128052#stopped","date":"2026-11-11T23:19:59.750Z"}}],"pending":[{"what":"Programs on the target by phase and months behind the leader","source":"Programs and Drugs@FDA (ticket 33)"}]},{"n":5,"question":"Can it be approved, and stay approved?","flags":[{"id":"single_country","label":"Single-country","value":"no","detail":"43 sites in 2 countries; 36 in the United States (84%)","rule":"All listed sites are in one country; the share of US sites is shown","source":{"label":"ClinicalTrials.gov NCT05773274","url":"https://clinicaltrials.gov/study/NCT05773274?tab=locations","date":"2026-11-11T23:19:59.719Z"},"context":[]},{"id":"eu_pip","label":"EU paediatric investigation plan","value":"yes","detail":"EMEA-001143-PIP01-11-M06 (cabozantinib, Treatment of solid malignant tumours): PM: decision on the application for modification of an agreed PIP, 7 Aug 2023; EMEA-000342-PIP01-08-M07 (sunitinib, Treatment of gastro-intestinal stromal tumours): PM: decision on the application for modification of an agreed PIP, 7 May 2018; compliance positive 29 Jun 2018; EMEA-000019-PIP08-12-M03 (everolimus, Treatment of tuberous sclerosis complex): PM: decision on the application for modification of an agreed PIP, 31 Oct 2017; compliance positive 1 Jun 2018; EMEA-000019-PIP11-14 (everolimus, Treatment of thoracic neuroendocrine tumour): W: decision granting a waiver in all age groups for all conditions or indications, 30 Jan 2015; +4 more","rule":"An EMA PIP decision (agreement, modification or waiver) lists the drug as its active substance, exact name","source":{"label":"EMA data download (dated snapshot)","url":"https://www.ema.europa.eu/en/documents/report/medicines-output-paediatric_investigation_plans-output-json-report_en.json","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"eu_orphan","label":"EU orphan designation","value":"yes","detail":"EU/3/08/610 positive 6 Feb 2009: Treatment of medullary thyroid carcinoma; EU/3/10/764 expired 4 Aug 2010: Treatment of tuberous sclerosis; EU/3/07/488 withdrawn 14 Nov 2007: Treatment of gastro-entero-pancreatic neuroendocrine tumours; EU/3/11/894 withdrawn 30 Aug 2011: Treatment of gastric cancer; +1 more","rule":"An EU orphan designation lists the drug as its active substance (exact name) or belongs to a medicine that does; withdrawn and expired designations are listed with their status","source":{"label":"EMA data download (dated snapshot)","url":"https://www.ema.europa.eu/en/documents/report/medicines-output-orphan_designations-json-report_en.json","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"eu_authorised","label":"Authorised in the EU","value":"yes","detail":"Afinitor: authorised since 2 Aug 2009; Cabometyx: authorised since 9 Sept 2016; Cometriq: authorised since 21 Mar 2014, orphan medicine; Sunitinib Accord: authorised since 11 Feb 2021; +2 more","rule":"An EMA medicine record lists the drug as its active substance or INN, exact name; national-only authorisations are not in this file","source":{"label":"EMA data download (dated snapshot)","url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"fda_orphan","label":"FDA orphan designation","value":"not published","detail":"FDA's orphan designation database turns away automated requests, so this app does not read it; search it by hand at the link","rule":"Would be: an FDA orphan designation names the drug","source":{"label":"FDA orphan designations search","url":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/","date":""},"context":[]},{"id":"fda_ped_approval","label":"FDA pediatric oncology approval","value":"yes","detail":"Cabozantinib [Cabometyx], 26 Mar 2025: Treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET); Cabozantinib [Cabometyx], 26 Mar 2025: Treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET); Cabozantinib [Cabometyx], 17 Sept 2021: Treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible; +2 more","rule":"FDA's Pediatric Oncology Drug Approvals table names the drug","source":{"label":"FDA Pediatric Oncology Drug Approvals (content current as of 2026-03-03)","url":"https://www.fda.gov/about-fda/oncology-center-excellence/pediatric-oncology-drug-approvals","date":"2026-11-11T23:19:59.764Z"},"context":[]},{"id":"studies_under_18","label":"Registered studies open to children","value":"yes","detail":"153 interventional studies of Cabozantinib, Everolimus, Lutetium Lu 177 Dotatate, Sunitinib include patients under 18; 43 are recruiting, not yet recruiting or active","rule":"The registry's age group includes Child (birth to 17 years), which also counts studies that set no minimum age","source":{"label":"ClinicalTrials.gov search","url":"https://clinicaltrials.gov/search?intr=%22Cabozantinib%22+OR+%22Everolimus%22+OR+%22Lutetium+Lu+177+Dotatate%22+OR+%22Sunitinib%22&aggFilters=ages%3Achild%2CstudyType%3Aint","date":"2026-11-11T23:19:59.768Z"},"context":[]}],"facts":[{"label":"Caveat","text":"Site counts are not patients per country, and trials registered only outside ClinicalTrials.gov are not covered. Where the sites are is a fact about the record, not a judgement of its quality."},{"label":"Rare pediatric disease voucher","text":"FDA, content current as of 29 Apr 2026: “As of February 3, 2026, enactment of the Consolidated Appropriations Act, 2026, the rare pediatric disease PRV program will sunset after September 30, 2029. FDA may not award any PRVs under this program after September 30, 2029.” Voucher sale prices are not shown here; they appear only as company-reported news.","source":{"label":"FDA: Rare Pediatric Disease Designation and Priority Review Voucher Programs","url":"https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/rare-pediatric-disease-designation-and-priority-review-voucher-programs","date":"2026-11-11"}}],"pending":[{"what":"Precedent approvals for target, modality and endpoint; accelerated-approval status","source":"Drugs@FDA and FDA accelerated-approval tables (ticket 30)"}]},{"n":6,"question":"Can the sponsor finish?","flags":[],"facts":[{"label":"Sponsor","text":"National Cancer Institute (NCI) (academic or other)","source":{"label":"ClinicalTrials.gov NCT05773274","url":"https://clinicaltrials.gov/study/NCT05773274","date":"2026-11-11T23:19:59.719Z"}},{"label":"principal investigator","text":"Simron Singh, Canadian Cancer Trials Group","source":{"label":"Person page","url":"/person/Simron%20Singh","date":"2026-11-11T23:19:59.719Z"}}],"pending":[{"what":"Filed cash, quarterly spend and the runway arithmetic","source":"SEC XBRL company facts (ticket 37)"},{"what":"Sponsor's completed vs stopped oncology trials and results-reporting record","source":"Registry, by company (ticket 37)"}]}],"limits":"Public records cannot show: sales forecasts; a probability of success for this asset; full deal terms and net prices; FDA designations and action dates before approval (shown only as company-reported); clinical holds unless the company disclosed them; manufacturing; patents on unapproved drugs; whether preclinical findings have been replicated.","sources":[{"label":"ClinicalTrials.gov NCT05773274","url":"https://clinicaltrials.gov/study/NCT05773274","date":"2026-11-11T23:19:59.719Z"},{"label":"Open Targets Platform","url":"https://platform.opentargets.org","date":"2026-11-11T23:19:59.719Z"},{"label":"FDA Pediatric Molecular Target List (Listed as February 2026 on the FDA Pediatric Oncology page; the file served is 9.7.22_the_relevant_molecular_target_list.xlsx, whose Summary of Changes sheet is headed 'SEPTEMBER 2022 UPDATE' (footnote date 2022-09-01))","url":"https://www.fda.gov/media/191157/download?attachment","date":"2026-11-11T07:05:03Z"}]},"source":"ClinicalTrials.gov + Open Targets","fetchedAt":"2026-11-11T23:19:59.714Z"}