OncoSignal

Decision brief · what the records say, not our assessment

Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial

NCT05773274 · National Cancer Institute (NCI) · PHASE2 · recruiting · Open Targets disease: digestive system mixed adenoneuroendocrine carcinoma

Six questions a reader deciding whether to spend more time on this asks, each answered with flags: yes, no, or not published (hatched), each with its rule and source record. Flags are never added up into a score or a verdict, because published success rates disagree by a factor of two and more.

1. Is the biology right?

  • Not loaded on this app yet: Normal-tissue expression in vital organs. Source: Human Protein Atlas (ticket 36).
  • Not loaded on this app yet: Pan-essential in cell lines. Source: DepMap (ticket 36).
  • Not loaded on this app yet: Approved drug on this target. Source: Drugs@FDA (ticket 30).

2. Can the result be trusted?

  • Randomised: yes · Randomised allocation
    Rule: Registry allocation field. Source: ClinicalTrials.gov NCT05773274, 2026-11-11
  • Small denominator: no · 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: ClinicalTrials.gov NCT05773274, 2026-11-11
  • Primary endpoint is overall survival: no · Progression-free survival (PFS)
    Rule: A registered primary outcome measure names overall survival. Source: ClinicalTrials.gov NCT05773274, 2026-11-11
    Published context: Non-OS primary endpoint: odds ratio 2.79 for a positive phase 3 (Otsuka 2021, 400 phase 3 oncology trials, to 2020). Shown with the next figure: a surrogate is easier to hit, and often a weak guide to survival.
    Published context: 52% of surrogate-to-OS correlations are low (Prasad 2015, published to 2014). Shown with the figure above.
  • Results overdue: no · 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: ClinicalTrials.gov NCT05773274, 2026-11-11
  • Not loaded on this app yet: Treated and evaluable counts, assessor, confirmed response, follow-up and data cutoff. Source: Readout extraction (ticket 32).
  • Not loaded on this app yet: Primary endpoint changed between registry versions. Source: Registry versions in the store (ticket 32).

3. What must it beat?

  • Not loaded on this app yet: Control-arm result and approved therapies for the same segment, with label links. Source: Drugs@FDA, FDA labels and readouts (tickets 30, 32).

4. Too crowded, or too late?

  • Stopped on this target: 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. · KDR: what already stopped
  • Not loaded on this app yet: Programs on the target by phase and months behind the leader. Source: Programs and Drugs@FDA (ticket 33).

5. Can it be approved, and stay approved?

  • Single-country: no · 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: ClinicalTrials.gov NCT05773274, 2026-11-11
  • EU paediatric investigation plan: yes · 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: EMA data download (dated snapshot), 2026-11-11
  • EU orphan designation: yes · 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: EMA data download (dated snapshot), 2026-11-11
  • Authorised in the EU: yes · 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: EMA data download (dated snapshot), 2026-11-11
  • FDA orphan designation: not published · 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: FDA orphan designations search
  • FDA pediatric oncology approval: yes · 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: FDA Pediatric Oncology Drug Approvals (content current as of 2026-03-03), 2026-11-11
  • Registered studies open to children: yes · 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: ClinicalTrials.gov search, 2026-11-11
  • Caveat: 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.
  • Rare pediatric disease voucher: 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. · FDA: Rare Pediatric Disease Designation and Priority Review Voucher Programs
  • Not loaded on this app yet: Precedent approvals for target, modality and endpoint; accelerated-approval status. Source: Drugs@FDA and FDA accelerated-approval tables (ticket 30).

6. Can the sponsor finish?

  • Not loaded on this app yet: Filed cash, quarterly spend and the runway arithmetic. Source: SEC XBRL company facts (ticket 37).
  • Not loaded on this app yet: Sponsor's completed vs stopped oncology trials and results-reporting record. Source: Registry, by company (ticket 37).

What public data cannot tell you

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: ClinicalTrials.gov NCT05773274 (2026-11-11); Open Targets Platform (2026-11-11); 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)) (2026-11-11). JSON: /api/brief/trial/NCT05773274. Not medical advice.