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Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors

ConditionsPancreatic Neuroendocrine Tumor (pNET)Extra-Pancreatic Neuroendocrine Tumor (epNET)
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorExelixis

About this trial

The primary purpose of this study is to assess the effectiveness of zanzalintinib compared to everolimus in participants with previously treated, unresectable, locally advanced or metastatic neuroendocrine tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed, locally advanced/unresectable or metastatic, well-differentiated Grade 1, 2, or 3 NETs of pancreatic origin or extra-pancreatic origin.

Allowed prior lines of therapy, based on the site of NET and functional status.

Documented radiographic disease progression per RECIST 1.1, as assessed by the Investigator based on imaging assessments (computed tomography [CT] or magnetic resonance imaging [MRI]) within 12 months before randomization.

Measurable disease according to RECIST 1.1 as determined by the Investigator.

Disqualifiers

Histologically confirmed neuroendocrine carcinomas (including small cell lung cancer), medullary thyroid cancer, pheochromocytoma, paraganglioma, Merkel cell carcinoma, and mixed neuroendocrine non-neuroendocrine neoplasm (MiNEN).

Prior treatment with a vascular endothelial growth factor receptor (VEGFR) -targeting tyrosine kinase inhibitor or a mammalian target of rapamycin (mTOR) inhibitor.

Systemic chemotherapy and any liver-directed or other ablative therapy within 4 weeks before randomization.

Systemic radionuclide therapy within 6 weeks before randomization.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Zanzalintinib

    Drug

    Administered as specified in the treatment arm.

  • Everolimus

    Drug

    Administered as specified in the treatment arm.

Treatment groups

440 Participants
are divided into 2 treatment groups
Group A: EverolimusActive comparator 1 intervention
Group B: ZanzalintinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)

Time frame
Up to 48 months

Secondary outcomes

1

PFS Per RECIST 1.1 as Assessed by Investigator

Time frame
Up to 48 months
2

Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR and Investigator

Time frame
Up to 48 months
3

Overall Survival (OS)

Time frame
Up to 60 months
4

Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR and Investigator

Time frame
Up to 48 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Exelixis

Lead sponsor

Source ClinicalTrials.gov
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