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NCT03691064: SALUS
Post-Authorization Long-Term Safety Study of LUTATHERA
trial testing LUTATHERA in Neuroendocrine Tumors in 1,014 participants. Participants enrolled and being followed up; not accepting new ones.
30 September 2027
Quick facts
| Lead sponsor | Advanced Accelerator Applications |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 1,014 |
| Start date | 28 November 2018 |
| Primary completion | 30 September 2027 |
| Estimated completion | 30 September 2027 |
| Sites | 20 locations across France, United Kingdom, Portugal, United States, Spain |
Drugs / interventions tested
- LUTATHERA (lutetium (177Lu) oxodotreotide) — full drug profile →
Conditions studied
- Neuroendocrine Tumors — all drugs for Neuroendocrine Tumors →
Sponsor
Advanced Accelerator Applications — full company profile →
Who can join
18 and older, any sex, with Neuroendocrine Tumors. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03691064
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of LUTATHERA
Trials testing the same drug.
- NCT05844332 — LUTATHERA Injection General Use Result Survey · completed
Other recruiting trials for Neuroendocrine Tumors
Currently open trials in the same condition.
- NCT07404176 — Study to Assess the Safety and Effectiveness of Novel Radiopharmaceutical Terbium-161 DOTATATE in Metastatic Neuroendocr · Phase 2 · recruiting
- NCT07314164 — Study of Cabozantinib in Participants With Neuroendocrine Tumors Who Have Already Received Prior Treatment · recruiting
- NCT07272512 — Prospective Multicenter Real-world Study of Surufatinib in Patients With Advanced Neuroendocrine Neoplasms · Phase 4 · recruiting
- NCT06735560 — Study Assessing PET Imaging With Zirconium-labelled Girentuximab in Patients With HCC, ICC or NEN · NA · recruiting
- NCT06889493 — SVV-001 With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas (NEC) or Well-Dif · Phase 1 · recruiting
Other Advanced Accelerator Applications trials
Trials by the same sponsor.
- NCT04711135 — Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs · Phase 2 · active not recruiting
- NCT04524442 — Post-Authorization Safety Study (PASS) of LysaKare® in Adult Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patie · Phase 4 · completed
- NCT03972488 — Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET · Phase 3 · active not recruiting
- NCT03872778 — [177Lu]-NeoB in Patients With Advanced Solid Tumors and With [68Ga]-neoB Lesion Uptake · Phase 1, PHASE2 · completed
- NCT03724253 — [68Ga]-NeoBOMB1 Imaging in Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR) · Phase 2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03691064 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Advanced Accelerator Applications
- Last refreshed: 23 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03691064.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing