NCT04375267: LuPARP

177Lu-DOTA-TATE and Olaparib in Somatostatin Receptor Positive Tumours

Completed Phase 1 Last updated 14 April 2026

What this trial tests

Phase 1 trial testing 177Lu-DOTA-TATE + olaparib in Clinical Trial, Phase I in 18 participants. Completed in 30 June 2024.

Timeline

23 April 2020

Primary endpoint
30 June 2024

30 June 2024

Quick facts

Lead sponsor	Vastra Gotaland Region
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	23 April 2020
Primary completion	30 June 2024
Estimated completion	30 June 2024
Sites	1 location across Sweden

Drugs / interventions tested

• 177Lu-DOTA-TATE + olaparib — full drug profile →

Conditions studied

• Clinical Trial, Phase I — all drugs for Clinical Trial, Phase I →
• Neuroendocrine Tumors — all drugs for Neuroendocrine Tumors →
• Thymoma — all drugs for Thymoma →
• Mesothelioma — all drugs for Mesothelioma →

Sponsor

Vastra Gotaland Region — full company profile →

Who can join

18 and older, any sex, with Clinical Trial, Phase I or Neuroendocrine Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase I study of 177Lu-DOTA-TATE in combination with the PARP-inhibitor olaparib for treatment of patients with somatostatin receptor positive tumours detected by 68Ga-DOTA-TATE/TOC PET. The combination of a PARP inhibitor that will specifically target the repair mechanism, with ionising radiation causing SSB's might overcome the repair dependent survival of the tumour cells, making them more sensitive to β-emission and increase the probability of tumour cell death.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting DNA repair pathway in cancer: Mechanisms and clinical application.
   Wang M, Chen S, Ao D. · · 2021 · cited 84× · PMID 34977872 · DOI 10.1002/mco2.103
2. Combination Strategies to Improve Targeted Radionuclide Therapy.
   Chan TG, O'Neill E, Habjan C, Cornelissen B. · · 2020 · cited 58× · PMID 33037092 · DOI 10.2967/jnumed.120.248062
3. Recent advances and impending challenges for the radiopharmaceutical sciences in oncology.
   Lapi SE, Scott PJH, Scott AM, Windhorst AD, et al · · 2024 · cited 39× · PMID 38821098 · DOI 10.1016/s1470-2045(24)00030-5
4. ²²⁵Ac-MACROPATATE: A Novel α-Particle Peptide Receptor Radionuclide Therapy for Neuroendocrine Tumors.
   King AP, Gutsche NT, Raju N, Fayn S, et al · · 2023 · cited 35× · PMID 36396453 · DOI 10.2967/jnumed.122.264707
5. Lutathera^® Orphans: State of the Art and Future Application of Radioligand Therapy with ¹⁷⁷Lu-DOTATATE.
   Urso L, Nieri A, Uccelli L, Castello A, et al · · 2023 · cited 29× · PMID 37111596 · DOI 10.3390/pharmaceutics15041110
6. Neuroendocrine Tumors and Peptide Receptor Radionuclide Therapy: When Is the Right Time?
   Hope TA, Pavel M, Bergsland EK. · · 2022 · cited 28× · PMID 35649195 · DOI 10.1200/jco.22.00176
7. A Primer on Radiopharmaceutical Therapy.
   Salerno KE, Roy S, Ribaudo C, Fisher T, et al · · 2023 · cited 25× · PMID 35970373 · DOI 10.1016/j.ijrobp.2022.08.010
8. Peptide receptor radionuclide therapy combinations for neuroendocrine tumours in ongoing clinical trials: status 2023.
   di Santo G, Santo G, Sviridenko A, Virgolini I. · · 2024 · cited 24× · PMID 38250038 · DOI 10.7150/thno.91268