Phase 2
Completed N=111
Lenvatinib Efficacy in Metastatic Neuroendocrine Tumors
Source: ClinicalTrials.gov NCT02678780 ↗Enrolled (actual)
111
Serious AEs
42.3%
Results posted
Jul 2025
Primary outcomePrimary: Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment — 0; 0; 23; 9 Participants
Summary
This is a prospective, international, multi-center, open label, stratified, exploratory phase II study evaluating the efficacy and safety of lenvatinib in patients with advanced/metastatic, neuroendocrine tumors of the pancreas after progression to a previous targeted agent (cohort A) or gastrointestinal tract after progression to somatostatin analogues (cohort B).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment |
0; 0; 23; 9; 27; 42 | — |
| PRIMARY Overall Response Rate (ORR) by RECIST v 1.1 Upon Central Radiologic Assessment |
44.23; 16.36 | — |
| SECONDARY Progression-free Survival (PFS) |
12; 12; 34; 36; 5; 7 | — |
| SECONDARY Number of Participants With Early Tumor Shrinkage (ETS) |
32; 46; 20; 5 | — |
| SECONDARY Deepness of Response (DpR) |
-26.28; -15.34 | — |
| SECONDARY Tumour Shrinkage |
6; 6; 46; 46 | — |
Eligibility Criteria
INCLUSION CRITERIA
Subjects must meet all of the following criteria to be included in this study:
- Subjects must have histologically confirmed diagnosis of one of the following advanced/metastatic neuroendocrine tumor types:
- WHO Classification G1/G2 (Ki67 1+ proteinuria on urine dipstick testing will undergo 24h urine collection for quantitative assessment of proteinuria. Subjects with urine protein ≥ 1 g/24h will be ineligible.
- Gastrointestinal malabsorption, or any other condition in the opinion of the investigator that might affect the absorption of lenvatinib.
- Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina; myocardial infarction or stroke within 6 months prior to the first dose of study drug, or cardiac arrhythmia requiring medical treatment. The left ventricular ejection fraction in the echocardiogram must be of at least 50%.
- Prolongation of QTcF interval to > 480 msec.
- Bleeding or thrombotic disorders or use of anticoagulants, such as warfarin, or similar agents requiring therapeutic international normalized ration (INR) monitoring. Treatment with low molecular weight heparin (LMWH) is allowed.
- Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.
- Active infection (any infection requiring treatment).
- Active malignancy within the past 5 years (except for definitely treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix).
- Known intolerance or hypersensitivity to the active substance (or any of the excipients).
- Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial.
- Females who are pregnant or breastfeeding.
- Documented active alcohol or drug abuse.
- Patients with a prior history of non-compliance with medical regimens.
Data sourced from ClinicalTrials.gov (NCT02678780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.