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GCO-003 TARLANEC A randomized phase III trial study comparing tarlatamab with standard of care chemotherapy in patients with pre-treated advanced, refractory pulmonary or gastroenteropancreatic poorly differentiated neuroendocrine carcinomas

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515948-23-00
Acronym
GCO-003 TARLANEC
Enrollment
129
Registered
2025-09-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced pulmonary or gastroenteropancreatic poorly differentiated neuroendocrine carcinomas (NECs)

Brief summary

Overall survival (OS) in patients who received at least one dose of treatment.

Detailed description

Incidence, nature, and severity of treatment-related adverse events/treatment-emergent adverse events, graded according to the NCI CTCAE v5.0 except CRS and ICANS events graded using ASTCT 2019, Objective Response Rate (ORR), Duration of response (DoR), Disease Control Rate (DCR), Progression Free Survival (PFS), Overall Survival (OS), Quality of life of questionnaire EORTC QLQ-C30

Interventions

DRUGTarlatamab
DRUGOXALIPLATINE VIATRIS 5 mg/ml
DRUGDacarbazine "Lipomed"
DRUGTecentriq 1 200 mg concentrate for solution for infusion
DRUGTemozolomide 100 mg hard capsules
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGTopotecan Accord Healthcare 4mg Powder for Concentrate for Solution for Infusion
DRUGsolution à diluer pour perfusion

Sponsors

Intergroupe Francophone De Cancerologie Thoracique
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Overall survival (OS) in patients who received at least one dose of treatment.

Secondary

MeasureTime frame
Incidence, nature, and severity of treatment-related adverse events/treatment-emergent adverse events, graded according to the NCI CTCAE v5.0 except CRS and ICANS events graded using ASTCT 2019, Objective Response Rate (ORR), Duration of response (DoR), Disease Control Rate (DCR), Progression Free Survival (PFS), Overall Survival (OS), Quality of life of questionnaire EORTC QLQ-C30

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026