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Neuroendocrine Tumors,GastroenteropancreaticPhase 1/2NCT05048901

Cabozantinib and Lanreotide as Treatment for Gastroenteropancreatic Neuroendocrine Tumors

A Phase 1/2 study testing Cabozantinib and Lanreotide in people with Neuroendocrine Tumors,Gastroenteropancreatic, run by National Health Research Institutes, Taiwan at 11 sites in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is an Open-Label Phase I/II Study of daily cabozantinib plus lanreotide every 4 w eeks to treat advanced G1-2 gastroentero-pancreatic neuroendocrine tumor (GEP-NET) patients who failed to one line or more than one line of small molecule kinase inhibitor or well-differentiated (W-D) G3 GEP-NET who failed to one… Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Cabozantinib and Lanreotide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
11 sitesTaiwan
Study dates
17 Sep 2021to 31 Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Pathologically confirmed G1 or G2 NET of GEP origin with locally advanced or metastatic stage who failed to one line or more than one line of small molecular kinase inhibitor (mTOR inhibitor or other targeted kinase inhibitor) or W-D G3 NET of GEP origin with locally advanced or metastatic stage who failed to one line or more than one line of chemotherapy or small molecule kinase inhibitor.
  • Radiologic progression within 12 months of entry
  • Recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically non-significant and/or stable on supportive therapy.
  • Age≥ 20 years old and ECOG Performance Status ≤ 1.
  • Adequate organ and marrow function, based upon meeting all the following laboratory criteria within 14 days before first dose of study treatment:
  • Absolute neutrophil count (ANC) ≥ 1500/µL without granulocyte colony- stimulating factor support.
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  • White blood cell count ≥ 2500/µL.
  • Platelets ≥ 100,000/µL without transfusion.
  • Hemoglobin ≥ 9 g/dL (≥ 90 g/L).
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 x upper limit of normal (ULN). If there is liver metastasis, AST, ALT ≤ 5 x ULN. ALP ≤ 5 x ULN with documented bone metastases.
  • Total bilirubin ≤ 1.5 x ULN (for subjects with Gilbert's disease ≤ 3 x ULN).
  • Serum albumin ≥ 2.8 g/dl
  • (PT)/INR or partial thromboplastin time (PTT) test < 1.3 x the laboratory ULN
  • Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 50 mL/min (≥ 0.5 mL/sec) using the Cockcroft-Gault equation:
  • Males: (140 - age) x weight (kg)/(serum creatinine [mg/dL] × 72) Females: [(140 - age) x weight (kg)/(serum creatinine [mg/dL] ×72)] × 0.85
  • Urine protein/creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol), or 24-h urine protein ≤ 1 g
  • At least one measurable lesion according to RECIST 1.1 over non-locally treated site, such as RT, TAE (TACE), or RFA.
  • Life expectancy greater than 12 weeks.
  • Capable of understanding and complying with the protocol requirements and must have signed informed consent document.
  • Female subjects of childbearing potential (i.e. less than or equal to 2 years post-menopause and not surgically sterile) and their partners must agree to use highly effective methods of contraception (that alone or in combination result in a failure rate of less than 1% per year when used consistently and correctly during the course of the study and for 4 months after the last dose of study treatment.
  • Effective methods of birth control include:
  • Hormonal contraception (oral, injectable, implantable, transdermal) plus a barrier method;
  • intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) plus a barrier method;
  • bilateral tubal occlusion (females);
  • vasectomized partner (males).
  • Female subjects of childbearing potential must not be pregnant at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria are met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman > 45 years-of-age in the absence of other biological or physiological causes. In addition, females < 55 years-of-age must have a serum follicle stimulating (FSH) level > 40 mIU/mL to confirm menopause). Note: Documentation may include review of medical records, medical examinations, or medical history interview by study site.

Who cannot join

  • Prior use of cabozantinib. (prior use of lanreotide is acceptable)
  • Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks or 5 half-lives of the agent, whichever is longer, before first dose of study treatment.
  • Receipt of any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before first dose of study treatment.
  • Receipt of radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
  • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment after radiotherapy or at least 4 weeks prior to first dose of study treatment after major surgery (e.g., removal or biopsy of brain metastasis). Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment.
  • Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:
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  • Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).
  • Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
  • The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
  • Cardiovascular disorders:
  • Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias.
  • Uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment.
  • Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months before first dose of study treatment.
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  • Subjects with a diagnosis of incidental, subsegmental PE or deep vein thrombosis (DVT) within 6 months are allowed if stable, asymptomatic, and treated with a stable dose of permitted anticoagulation (see exclusion criterion #6) for at least 1 week before first dose of study treatment.
  • Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:
  • The subject has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction.
  • Abdominal fistula, GI perforation, bowel obstruction, or intra- abdominal abscess within 6 months before first dose of study treatment.
  • Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.
  • Major surgery within 4 weeks prior to study enrolment. Complete wound healing within 2 weeks before treatment.
  • Clinically significant hematuria, hematemesis, or hemoptysis of > 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study treatment.
  • Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation.
  • Lesions invading or encasing any major blood vessels.
  • Other clinically significant disorders that would preclude safe study participation.
  • Serious non-healing wound/ulcer/bone fracture.
  • Uncompensated/symptomatic hypothyroidism.
  • Moderate to severe hepatic impairment (Child-Pugh B or C).
  • Major surgery (e.g., laparoscopic nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 4 weeks before first dose of study treatment. Minor surgeries within 2 weeks before first dose of study treatment. Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.
  • Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms per electrocardiogram (ECG) within 14 days before first dose of study treatment [add reference for Fridericia formula].
  • Note: If a single ECG shows a QTcF with an absolute value > 500 ms, two additional ECGs at intervals of approximately 3 min must be performed within 30 min after the initial ECG, and the average of these three consecutive results for QTcF will be used to determine eligibility.
  • Pregnant or lactating females.
  • Inability to swallow tablets.
  • Previously identified allergy or hypersensitivity to components of the study treatment formulations.
  • Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast, or stage 0-I colon or breast cancer treated by surgery only and without evidence of relapsed tumor.
  • Mental status is not fit for clinical trial

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ya-Ling Wu, BS contact

886-3-7206166 ext. 35119

yalin@nhri.edu.tw

Hui-Jen Tsai, PhD contact

886-6-2353535 ext. 65149

hjtsai@nhri.org.tw

11 sites in 1 country

Taiwan11 sites, 11 recruiting

  • Changhua Christian Hospital

    Changhua

    Chuan-Cheng Wan, PhD

    Recruiting

  • Chang Gung Medical Foundation

    Kaohsiung City

    Yen-Yang Chen, PhD

    Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

    Li-Tzong Chen, PhD

    Recruiting

  • China Medical University Hospital

    Taichung

    Li-Yuan Bai, PhD

    Recruiting

  • Taichung Veterans General Hospital

    Taichung

    Youngsen Yang, PhD

    Recruiting

  • National Cheng Kung University Hospita

    Tainan

    Yan-Shen Shan, PhD

    Recruiting

  • Mackay Memorial Hospital

    Taipei

    Tsang-En Wang, MD

    Recruiting

  • National Taiwan University Hospital

    Taipei

    Hsiu-Po Wang, PhD

    Hsiu-Po Wang

    Recruiting

  • Taipei Veterans General Hospital

    Taipei

    Ming-Hung Chen, PhD

    Recruiting

  • Tri-Service General Hospital

    Taipei

    Jia-Hong Chen, PhD

    Recruiting

  • Chang Gung Medical Foundation

    Taoyuan

    Jen-Shi Chen, PhD

    Recruiting

Other trials in Taiwan

About this study

Official title: A Phase I/II Study Using Cabozantinib and Lanreotide as Treatment for Advanced Gastroenteropancreatic Neuroendocrine Tumors That Failed Molecular Targeted Therapies or Chemotherapy (SCALET)

This is an Open-Label Phase I/II Study of daily cabozantinib plus lanreotide every 4 w eeks to treat advanced G1-2 gastroentero-pancreatic neuroendocrine tumor (GEP-NET) patients who failed to one line or more than one line of small molecule kinase inhibitor or well-differentiated (W-D) G3 GEP-NET who failed to one line of small molecule kinase inhibitor or chemotherapy.

Read the detailed description

This is an Open-Label Phase I/II Study of daily cabozantinib plus lanreotide every 4 w eeks to treat advanced G1-2 gastroentero-pancreatic neuroendocrine tumor (GEP-NET) patients who failed to one line or more than one line of small molecule kinase inhibitor or well-differentiated (W-D) G3 GEP-NET who failed to one line of small molecule kinase inhibitor or chemotherapy. The primary objective of the study is to determine the maximal tolerated dose (MTD) of cabozantinib of this combinational regimen in the phase I study and the progression free survival in the phase II study. The secondary objectives are the objective response rate, overall survival, toxicities and biomarker analysis of this regimen.

Eligible patients will receive a combination of oral cabozantinib 40-60 mg/day and lanreotide 120mg deep subcutaneous injection (SC) in day 1 every 4 weeks. Four weeks is a cycle. The patients will continue to receive this regimen till disease progression, intolerable adverse events (after dose modification), death, or withdrawal by patients' or principle investigator's decision.

Being tested
Cabozantinib, Lanreotide
Medical subject headings
Neuroendocrine Tumors

What participants receive

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

  • CabozantinibDrug

    Also called Cabometyx

    Oral Cabozantinib 40-60 mg daily .every 4 weeks as a cycle

  • LanreotideDrug

    Also called Somatuline

    Lanreotide 120 mg deep SC on day 1 every 4 weeks.every 4 weeks as a cycle

Study groups in NCT05048901
Study groupRoleWhat they receive
Cabozantinib and LanreotideExperimentalOral cabozantinib 40-60 mg/day and lanreotide 120mg deep subcutaneous injection (SC) in day 1 every 4 weeks.
Receives: Drug: Cabozantinib; Drug: Lanreotide

What is being measured

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

  1. to determine the maximal tolerated dose of cabozantinib

    The dose of maximal tolerated dose of carbozantinib combination of cabozantinib and lanreotide for the recommended dose in phase II study.

    Measured: Phase I last patient in has been treated for 28 days

  2. Progression free survival

    The date of first study treatment to the date of disease progression.

    Measured: The time from registration to occurrence of progression based on the tumor response assessment by scheduled or un- scheduled CT scan or MRI. (whichever occurs first assessed up to 72 months)

Secondary outcomes (6)

  1. Response rate

    Estimates of response category frequencies with 95% confidence intervals will be computed.

    Measured: Every 8 weeks for first 4 cycles then every 3 cycles (12 weeks) until disease progress. (each cycle is 28 days)

  2. Overall survival

    the time from the date of first study treatment to the date of patient death, due to any cause, or to the last date the patient was known to be alive.

    Measured: The time from registration to death from any cause assessed up to 72 months.

  3. Toxicities

    Treatment toxicities and safety profiles,assessed by CTCAE v5.0

    Measured: Approximately 72 months.

  4. Genetic study

    Genetic study assessed by Next Generation Sequencing

    Measured: Approximately 72 months.

  5. Somatic mutation

    Somatic mutation assessed by Next Generation Sequencing

    Measured: Approximately 72 months.

  6. circulating tumor cells

    circulating tumor cells assessed by flow cytometry.

    Measured: Approximately 72 months.

Timeline

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

  1. First posted17 Sep 2021
  2. Study start17 Sep 2021
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05048901
Sponsor's protocol ID
T2221
Status last verified
Dec 2025
First submitted
12 Aug 2021
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Tsai HJ, Chen MH, Hsiao CF, Bai LY, Chen YY, Chou WC, Su YY, Dai MS, Liang YH, Shan YS, Yen CJ, Liu TH, Chen JH, Yang CY, Yen CC, Chen JS, Hsu HC, Su YL, Hsieh CH, Chen LT. A phase I/II study using cabozantinib and lanreotide as treatments for advanced GEP-NETs for which molecular targeted therapy or chemotherapy have failed (SCALET): TCOG T2221 study. ESMO Open. 2026 Nov 3;11(11):108618. doi: 10.1016/j.esmoop.2026.108618. Online ahead of print.

    PubMed 42976416

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cabozantinib and Lanreotide in people with Neuroendocrine Tumors,Gastroenteropancreatic, run by National Health Research Institutes, Taiwan at 11 sites in Taiwan.

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 26 inclusion and 35 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: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Taiwan. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Ya-Ling Wu, BS (886-3-7206166 ext. 35119, yalin@nhri.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

to determine the maximal tolerated dose of cabozantinib (time frame: Phase I last patient in has been treated for 28 days). 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 NCT05048901, which also lists 1 linked publication.

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 9 Apr 2026.

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