Refractory Advanced diGestive Neuroendocrine Carcinomas Treated With tARlatamab

Sponsor
Grupo Espanol de Tumores Neuroendocrinos
Study ID
NCT07061080
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Neuroendocrine Carcinomas Unknown Primary Origin
  • Advanced Neuroendocrine Carcinomas of The Digestive System

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tarlatamab — DRUG
    Tarlatamab as a standalone treatment through intravenous infusion at 10 mg dose every 14 days (i.e. 2 weeks)
  • standard of care second-line chemotherapy (FOLFIRI) — DRUG
    FOLFIRI:: irinotecan intravenously 180 mg/m2 on day 1, followed by 400 mg/m2 folinic acid or 200 mg/m² levofolinate in a 2-h infusion, a 10-min bolus of 400 mg/m2 5-FU, and 2400 mg/m2 5-FU over 46 hours; every 14 days).

Study Details

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.

Key Dates

Start date
Dec 18, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
87 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A: Tarlatamab
    Tarlatamab as a standalone treatment through intravenous infusion at 10 mg dose every 14 days (i.e. 2 weeks).
  • Experimental: ARM B: Tarlatamab plus FOLFIRI
    Tarlatamab as intravenous infusion at 10mg in combination with the standard of care second-line chemotherapy (FOLFIRI)

Primary Outcome Measure

Progression-free Survival (PFS) rate [ Time Frame: Throughout the study period, with an average follow-up of 3 years ]

Central Contacts