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RecruitingLast updated: 18 February 2026

PARLuNET: Evaluating a combination targeted treatment for people with metastatic pancreatic or midgut neuroendocrine tumours (NETs)Phase 1 Trial of PARP Inhibitor Combined With 177Lu-DOTA-Octreotate Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Metastatic NeuroEndocrine Tumor

Trial purpose

Medical clipboardCancer treatment

Tumor type

Neuroendocrine tumours Neuroendocrine tumours

Age

People18+

Trial acronym

PARLuNET

Clinical summary

Summary

This study aims to find out whether a new treatment combination is safe for people with metastatic pancreatic or midgut neuroendocrine tumours (NETs). This treatment involves talazoparib targeted therapy with 177Lu-DOTA-Octreotate peptide receptor radionuclide therapy (PRRT).

Eligible participants will receive 1 cycle of 177Lu-DOTA-Octreotate alone, which is a form of targeted radiation therapy, followed by 3 cycles of 177Lu-DOTA-Octreotate combined with 5 days of talazoparib.

Conditions

This trial is treating people with pancreatic neuroendocrine tumours

Eligibility

Inclusion

  1. Patient must be > or equal to18 years of age and must have provided written informed consent.
  2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  3. Histologically confirmed Grade 2 NET, Ki-67 of 3-20%, from pancreatic or intestinal origin.
  4. Patient clinically suitable for PRRT
  5. Tumor SSR uptake on GaTate PET/CT higher than liver activity, ≥ modified Krenning 3 score
  6. No discordant FDG-avid disease on FDG PET/CT
  7. No evidence of significant uncorrected carcinoid heart disease
  8. Patients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled assessments
  9. Patients must have adequate bone marrow, hepatic and renal function defined as:

    • Haemoglobin ≥100 g/L
    • Absolute neutrophil count ≥1.5x109/L
    • Platelets ≥150 x109/L
    • Total bilirubin ≤1.5 x upper limit of normal (ULN)
    • Aspartate transaminase (AST) (SGOT) and alanine transaminase (ALT) (SGPT)

      ≤2.5 x ULN if there is no evidence of liver metastasis or ≤5 x ULN in the presence of liver metastases.

    • Albumin ≥ 30 g/L
    • Adequate renal function: eGFR ≥ 50 ml/min

Exclusion

  1. Surgery or radiotherapy within <3 weeks of registration. Patients must have recovered from any effects of any major surgery.
  2. Any prior exposure to peptide receptor radionuclide therapy (177Lu, 111In or 90Y labelled), PARPi, immunotherapy
  3. Uncontrolled intercurrent illness that is likely to impede participation and /or compliance
  4. Other malignancies unless curatively treated with no evidence of disease within previous 3-years other than adequately treated non-melanoma skin cancer or melanoma in situ.
  5. Previous or current history of myelodysplastic syndrome/acute myeloid leukemia
  6. Patients unable to swallow orally administered medications or with gastrointestinal disorders likely to interfere with the absorption of the study medication.
  7. Use of strong P-gp inhibitors (eg, dronedarone, quinidine, ranolazine, verapamil, ketoconazole, itraconazole), P-gp inducers (eg, rifampin, tipranavir/ritonavir), or BCRP inhibitors (eg, elacridar [GF120918]) should be avoided.
  8. Participation in another clinical study with an investigational product or another systemic therapy administered in the last 3 weeks (except short acting SSA).

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Peter MacCallum Cancer Centre

Scientific Title

Phase 1 Trial of PARP Inhibitor Combined With 177Lu-DOTA-Octreotate Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Metastatic NeuroEndocrine Tumor

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