Actively Recruiting
Refractory Advanced diGestive Neuroendocrine Carcinomas Treated With tARlatamab
Led by Grupo Espanol de Tumores Neuroendocrinos · Updated on 2026-02-04
87
Participants Needed
19
Research Sites
154 weeks
Total Duration
On this page
Sponsors
G
Grupo Espanol de Tumores Neuroendocrinos
Lead Sponsor
A
Amgen
Collaborating Sponsor
AI-Summary
What this Trial Is About
Neuroendocrine neoplasms (NENs) comprise a heterogeneous family of neoplasms arising from the neuroendocrine cells localized in endocrine glands or from the diffuse neuroendocrine cells such as in the digestive or lung tract. Treatment for gastroenteropancreatic neuroendocrine tumors (GEP-NEC) is primarily based on chemotherapy regimens, primarily platinum, which achieve limited benefit and a median overall survival of approximately 12 months. Currently, new treatments that activate the immune system to stimulate antitumor responses and prolong survival in patients with NECs are being investigated. Given the high levels of DLL3 expression on the cell surface of neuroendocrine tumor cells and its minimal, primarily cytoplasmic, localization in normal tissues, DLL3 is a promising target for the development of T-cell-directed therapies in NECs. Tarlatamab is a HLE BiTE molecule that combines the binding specificities for DLL3 and CD3, which could activate the immune system to fight NEC cells. The main hypothesis is that treatment with tarlatamab, a bispecific anti-DLL3 and anti-CD3 conjugate, either as a single agent or in combination with standard second-line chemotherapy (FOLFIRI) scheme could be an effective treatment option for patients with advanced neuroendocrine carcinomas of the digestive system or unknown primary origin.
CONDITIONS
Official Title
Refractory Advanced diGestive Neuroendocrine Carcinomas Treated With tARlatamab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent approved by an ethics committee
- Be 18 years of age or older
- Have an ECOG performance status of 0 to 2
- Have histologically confirmed neuroendocrine carcinomas of the digestive system or unknown primary origin (excluding lung origin)
- Have Ki-67 index greater than 20% or mitotic rate over 20 per 10 high power fields
- Have metastatic or locally advanced unresectable disease after progression on first-line platinum-based chemotherapy or immunotherapy chemotherapy (excluding CD3/DLL3 BiTE)
- Have at least one measurable lesion according to RECIST v1.1
- Have tumors positive for DLL3 expression (1% or more of cells)
- Have adequate organ function including neutrophils ≥1.5 x 10^9/L, platelets ≥100 x 10^9/L, hemoglobin ≥9 g/dL, and liver and kidney function within specified limits
- Female participants must be postmenopausal, surgically sterile, or agree to pregnancy prevention measures including negative pregnancy tests and use of effective birth control
- Agree not to breastfeed or donate eggs during the study and 60 days after last tarlatamab dose or 6 months after FOLFIRI
- Male participants must agree not to donate sperm and use effective contraception if partner is of childbearing potential
- Agree not to participate in another interventional study while on treatment
You will not qualify if you...
- Have paraganglioma, adrenal, thyroid, parathyroid, or pituitary endocrine tumors
- Have lung neuroendocrine carcinoma (small or large cell)
- Have well-differentiated neuroendocrine tumors of the gastrointestinal tract or unknown origin
- Have had another malignancy within 2 years except certain treated cancers with no active disease
- Have received anti-cancer therapy less than 28 days prior to study treatment
- Have unresolved toxicity from previous therapy worse than grade 1 except specified exceptions
- Have had major surgery within 28 days before starting study treatment
- Have had radiation therapy less than 2 weeks prior to treatment (except some palliative radiotherapy)
- Have had myocardial infarction or symptomatic heart failure within 12 months
- Have cardiac ejection fraction below 50% or significant heart abnormalities
- Have history of arterial thrombosis within 12 months
- Have had solid organ transplantation
- Have immunodeficiency or recent immunosuppressive therapy
- Have severe immune-related adverse events or infusion reactions from previous treatments
- Have active autoimmune disease needing systemic treatment within 2 years or other diseases requiring immunosuppression
- Have interstitial lung disease or active pneumonitis
- Have hypophysitis or pituitary dysfunction
- Have active systemic infection within 7 days before treatment
- Have positive tests for active Hepatitis B or C infection
- Have received live vaccines within 28 days before treatment or during the study
- Have known allergy to components of study drugs
- Are pregnant, breastfeeding, or planning pregnancy during the study
- Have any other medical condition that may pose safety risks or interfere with the study as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Brest University Hospital Centre
Brest, Brest, France, 29200
Not Yet Recruiting
2
Centre Régional de Lutte Contre le Cancer Institut Bergonié (Bordeaux)
Bordeaux, Cedex, France, 33076
Not Yet Recruiting
3
Centre Oscar Lambret
Lille, Lille, France, 59020
Not Yet Recruiting
4
Hôpital Edouard Herriot (Hospices Civils Lyon)
Lyon, Lyon, France, 69003
Not Yet Recruiting
5
Institut de Cancérologie de l'Ouest (Angers/Nantes)
Nantes, Nantes, France
Not Yet Recruiting
6
Centre Hospitalier Universitaire de Toulouse
Toulouse, Toulouse, France, 31300
Not Yet Recruiting
7
Institut de Cancérologie de Lorraine (CLCC) Nancy
Vandœuvre-lès-Nancy, Vandœuvre-lès-Nancy Cedex, France, 54519
Not Yet Recruiting
8
Gustave Roussy
Villejuif, Villejuif,, France, 94800
Not Yet Recruiting
9
Hospital Clínico Universitario de Santiago
Santiago de Compostela, A Coruña, Spain, 15706
Not Yet Recruiting
10
H.U Germans Trias i Pujols
Badalona, Barcelona, Spain, 08916
Not Yet Recruiting
11
H.U. Vall d'Hebron
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
12
Hospital Universitario de Burgos (HUBU)
Burgos, Burgos, Spain, 09006
Not Yet Recruiting
13
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Not Yet Recruiting
14
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain, 28007
Not Yet Recruiting
15
H.U Ramón y Cajal
Madrid, Madrid, Spain, 28034
Not Yet Recruiting
16
Hospital 12 de Octubre
Madrid, Madrid, Spain, 28041
Not Yet Recruiting
17
H.U La Paz
Madrid, Madrid, Spain, 28046
Not Yet Recruiting
18
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, Spain, 46026
Not Yet Recruiting
19
Hospital Universitario Miguel Servet
Zaragoza, Zaragoza, Spain, 50009
Not Yet Recruiting
Research Team
F
Federico Nepote, M.D., PhD.
CONTACT
J
Jaume Capdevila, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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