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Neuroendocrine TumorsPhase 2TALENTNCT02678780

Lenvatinib Efficacy in Metastatic Neuroendocrine Tumors

A Phase 2 study testing Lenvatinib in people with Neuroendocrine Tumors, run by Grupo Espanol de Tumores Neuroendocrinos at 22 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuroendocrine Tumors
What is being tested?
Lenvatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
22 sitesin 4 countries
Study dates
Oct 2015to Aug 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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<20% and mitotic count ≤20 mitoses x 10 HPF) pancreatic neuroendocrine tumor
  • WHO Classification G1/G2 (Ki67<20% and mitotic count ≤20 mitoses x 10 HPF) gastrointestinal neuroendocrine tumor (including stomach, small intestine and colorectal origins).
  • Subjects must have evidence of measurable disease meeting the following criteria:
  • At least 1 lesion of ≥ 1.0 cm in the longest diameter for a non-lymph node, or ≥ 1.5 cm in the short-axis diameter for a lymph node, which is serially measurable according to RECIST 1.1 (Appendix I) using computerized tomography/magnetic resonance imaging (CT/MRI). If there is only one target lesion and it is a non-lymph node, it should have a longest diameter of ≥ 1.5 cm.
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  • Lesions that have had external beam radiotherapy (EBRT) or loco-regional therapies such as radiofrequency (RF) ablation or liver embolization must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.
  • Subjects must show evidence of disease progression by radiologic image techniques within 12 months (an additional month will be allowed to accommodate actual dates of performance of scans, i.e., within ≤ 13 months) prior to signing informed consent, according to RECIST 1.1 (Appendix I)
  • Subjects must meet the following inclusion criterion regarding primary tumor site:
  • Pancreatic origin: progression after a previous targeted agent (including mTOR inhibitors, such as everolimus or antiangiogenic therapies, such as sunitinib, sorafenib, axitinib, bevacizumab within others). Combination therapies in the same treatment line (such as sorafenib plus bevacizumab, chemotherapy plus antiangiogenic drugs) are considered one treatment line and are allowed to be included in the study. Patients must be treated with only one previous line of targeted agent(s)-based therapy.
  • Previous therapy with somatostatin analogues and/or interferon is allowed and is not considered as a previous targeted agent therapy.
  • Gastrointestinal origin: progression after therapy with antitumoral doses of somatostatin analogs (octreotide LAR 30 mg every 28 days or Lanreotide 120 mg every 28 days) and/or interferon treatment.
  • Only for patients with pancreatic origin neuroendocrine tumors, one previous line with chemotherapy is allowed.
  • Concomitant somatostatin analogues are allowed in both cohorts during the study.
  • Patients with known brain metastases who have completed whole brain radiotherapy, stereotactic radiosurgery or complete surgical resection, will be eligible if they have remained clinically stable, asymptomatic and off of steroids for at least one month.
  • All prior chemotherapy or radiation-related toxicities must have resolved to < Grade 2 (following CTCAE V 4.03 grade levels), except alopecia and infertility.
  • Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1 (Appendix II).
  • Previous liver locoregional therapies, such as (chemo) embolization, radiofrequency or liver-directed (radio) embolization, or systemic peptide-receptor radionucleotide therapy are allowed if the procedure was performed at least 6 months previous the informed consent form signature.
  • Adequately controlled blood pressure with or without antihypertensive medications, defined as BP < 150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the Screening Visit.
  • Adequate renal function defined as calculated creatinine clearance ≥ 30 mL/min per the Cockcroft and Gault formula (Appendix III).
  • Adequate bone marrow function, defined as:
  • Absolute neutrophil count (ANC) ≥ 1500/mm3 (≥ 1.5 ×103/μL).
  • Platelets ≥ 100,000/mm3 (≥ 100 × 109/L).
  • Hemoglobin ≥ 9.0 g/dL.
  • Adequate blood coagulation function as evidenced by an International Normalized Ratio (INR) ≤ 1.5. Prophylactic low molecular weight heparin therapy is allowed.
  • Adequate liver function:
  • Bilirubin ≤ 1.5 × the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome.
  • Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 3 × the ULN (≤ 5 × ULN if subject has liver metastases).
  • Males or females age ≥ 18 years at the time of informed consent.
  • All females must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta human chorionic gonadotropin (β-hCG) at the baseline visit (and/or within 72h prior to the first dose of study drug).
  • Females of childbearing potential must agree to use a highly effective method of contraception (e.g., total sexual abstinence, an intrauterine device, a double-barrier method such as condom + spermicide or condom + diaphragm with spermicide or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 30 days after study drug administration. The only subjects who will be exempt from this requirement are postmenopausal women (defined as women who have been amenorrheic for at least 12 consecutive months, in the appropriate age group, without other known or suspected primary cause) or subjects who have been sterilized surgically or who are otherwise proven sterile (i.e., bilateral tubal ligation with surgery at least 1 month prior to dosing, hysterectomy, or bilateral oophorectomy with surgery at least 1 month prior to dosing).
  • The women using oral hormonal contraceptives should add an additional barrier method as there is unknown whether lenvatinib may reduce the effectiveness of the hormonal contraceptives. All women who are of reproductive potential and who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation.
  • Sexual abstinence will be acceptable only when this is in line with the preferred and usual lifestyle of the subject.
  • Male subjects who are partners of women of childbearing potential must use or their partners must use a highly effective method of contraception (e.g., condom + spermicide, condom + diaphragm with spermicide, IUD) beginning at least 1 menstrual cycle prior to starting study drug(s), throughout the entire study period, and for 30 days after the last dose of study drug, unless they are sexually abstinent or have undergone a successful vasectomy. Those with partners using hormonal contraceptives must also be using an additional approved method of contraception, as described previously.
  • Voluntary provision of written informed consent and the willingness and ability to comply with all aspects of the protocol.

Who cannot join

  • WHO Classification G3 neuroendocrine tumors of the pancreas and gastrointestinal tract.
  • Two or more prior lines of targeted agents-based therapy in pancreatic origin and any previous line of targeted therapy for gastrointestinal origin or any ongoing antiproliferative treatment for advanced/metastatic neuroendocrine tumors, with the exception of somatostatin analogues therapy.
  • More than one previous line of chemotherapy in pancreatic neuroendocrine tumors.
  • Previous chemotherapy in gastrointestinal neuroendocrine tumors.
  • Prior treatment with lenvatinib.
  • Subjects who have received any anti-cancer treatment within 21 days or any investigational agent within 30 days prior to the first dose of study drug and should have recovered from any toxicity related to previous anti-cancer treatment. This does not apply to the use of somatostatin analogues for symptomatic therapy.
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  • Major surgery within 3 weeks prior to the first dose of study drug.
  • Subjects having > 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.

Trial locations and contacts

22 sites in 4 countries.

22 sites in 4 countries

Spain10 sites

  • Hospital Universitario Vall Hebrón

    Barcelona, 08035

  • Hospital de Donostia

    Donostia / San Sebastian, Basque Country

  • ICO Hospitalet

    L'Hospitalet de Llobregat, 08908

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario la Paz

    Madrid, 28046

  • Hospital Virgen de la Victoria

    Málaga, Andalusia, 29010

  • Hospital Central de Asturias

    Oviedo, Principality of Asturias, 33006

  • Hospital Marqués de Valdecilla

    Santander, Cantabria, 39011

  • Hospital Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Italy8 sites

  • Spedali Civili di Brescia

    Brescia

  • Instituto Oncologico Mediterraneo

    Catania

  • Azienda Ospedaliero Universitaria Careggi - SC di Oncologia

    Florence, 50139

  • IRST of Meldola

    Meldola

  • Istituto Europeo di Oncologia - Unità di Oncologia Medica Gastrointestinale e Tumori Neuroendocrini

    Milan, 20141

  • AOU Policlinico di Modena - DH Oncologico

    Modena, 41124

  • IRCCS Napoli

    Naples

  • Hospital Universatorio de Verona

    Verona

Other trials in Italy

Austria2 sites

  • Universitätsklinik für Innere Medizin

    Graz, 8036

  • Medizinische Universität Wien

    Vienna, a-1090

Other trials in Austria

United Kingdom2 sites

  • Beatson Oncology Centre Gartnavel General Hospital

    Glasgow, G12 0YN

  • Christie Hospital, Manchester

    Manchester, M20 4BX

Other trials in United Kingdom

About this study

Official title: Trial to Assess the Efficacy of Lenvatinib in Metastatic Neuroendocrine Tumors. (TALENT STUDY)

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).

Read the detailed description

Trial to assess the efficacy of Lenvatinib in metastatic neuroendocrine tumor. The primary endpoint of the study is overall response rate (ORR) by RECIST v 1.1 upon central radiologic assessment.

Number of patients: 110 patients Estimated duration of subject participation: 24 months

Being tested
Lenvatinib
Medical subject headings
Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02678780
Study groupRoleWhat they receive
Cohort AExperimentalPatients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of the pancreas after progression to a previous targeted agent. Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Receives: Drug: Lenvatinib
Cohort BExperimentalPatients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of gastrointestinal tract after progression to somatostatin analogues Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Receives: Drug: Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment

    Data cut-off for the primary study analysis will happen following after the last patient included in the study has performed the second tumor evaluation (week 18 after first dose of study drug as first evaluation will take place 6 weeks after first dose, following tumor assessment will take place every 12 weeks until documentation of disease progression or start of another anticancer therapy.

    Per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions: Complete Response (CR)= Disappearance of all target lesions; Partial Response (PR)= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease (PD)=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; Stable Disease (SD)= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Overall Response (OR) = CR + PR.

    Measured: Up to 18 months

  2. Overall Response Rate (ORR) by RECIST v 1.1 Upon Central Radiologic Assessment

    Data cut-off for the primary study analysis will happen following after th e last patient included in the study has performed the second tumor evaluation (week 18 after first dose of study drug as first evaluation will take place 6 weeks after first dose, following tumor assessment will take place every 12 weeks until documentation of disease progression or start of another anticancer therapy

    Measured: Up to 18 months

Secondary outcomes (4)

  1. Progression-free Survival (PFS)

    Progression-free survival (PFS) is defined as the time from the date of treatment start (C1D1)to the date of first documentation of disease progression or death (whichever Occurs first) using RECIST 1.1. PFS censoring rules will follow FDA guidance in 2007

    Measured: Up to 18 months

  2. Number of Participants With Early Tumor Shrinkage (ETS)

    To calculate early tumor shrinkage (ETS) rate, patients were classified as responders/non-responders after a period of 6 weeks (first post-baseline tumor assessment). Those who achieved a 20% reduction in target lesions after the first 6 weeks of treatment were classified as responders.

    Measured: Up to 18 months

  3. Deepness of Response (DpR)

    (DpR) defined as percentage of maximum tumor shrinkage observed at the nadir compared with baseline

    Measured: Up to 18 months

  4. Tumour Shrinkage

    Number of patients that exhibited a deepness of response lower than 0%.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2016 (estimated)
  2. Study startOct 2015
  3. Primary completionDec 2017
  4. Study completionAug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02678780
Sponsor's protocol ID
GETNE1509
Other IDs
2015-001467-39, 2015
Acronym
TALENT
Status last verified
Jul 2025
First submitted
1 Feb 2016
Last updated
24 Jul 2025
Data monitoring committee
No

Publications

  • Ligero M, Hernando J, Delgado E, Garcia-Ruiz A, Merino-Casabiel X, Ibrahim T, Fazio N, Lopez C, Teule A, Valle JW, Tafuto S, Custodio A, Reed N, Raderer M, Grande E, Garcia-Carbonero R, Jimenez-Fonseca P, Garcia-Alvarez A, Escobar M, Casanovas O, Capdevila J, Perez-Lopez R. Radiomics and outcome prediction to antiangiogenic treatment in advanced gastroenteropancreatic neuroendocrine tumours: findings from the phase II TALENT trial. BJC Rep. 2023 Aug 2;1(1):9. doi: 10.1038/s44276-023-00010-0.

    PubMed 39516643

  • Capdevila J, Fazio N, Lopez C, Teule A, Valle JW, Tafuto S, Custodio A, Reed N, Raderer M, Grande E, Garcia-Carbonero R, Jimenez-Fonseca P, Hernando J, Bongiovanni A, Spada F, Alonso V, Antonuzzo L, Spallanzani A, Berruti A, La Casta A, Sevilla I, Kump P, Giuffrida D, Merino X, Trejo L, Gajate P, Matos I, Lamarca A, Ibrahim T. Lenvatinib in Patients With Advanced Grade 1/2 Pancreatic and Gastrointestinal Neuroendocrine Tumors: Results of the Phase II TALENT Trial (GETNE1509). J Clin Oncol. 2021 Jul 10;39(20):2304-2312. doi: 10.1200/JCO.20.03368. Epub 2021 May 4.

    PubMed 33945297

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenvatinib in people with Neuroendocrine Tumors, run by Grupo Espanol de Tumores Neuroendocrinos at 22 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 35 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Spain, Italy, Austria, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment (time frame: Up to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02678780, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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