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A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in combination with Durvalumab, Carboplatin and Etoposide versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-520050-38-00
Acronym
20240178
Enrollment
129
Registered
2025-09-01
Start date
2025-09-18
Completion date
Unknown
Last updated
2025-10-24

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

Conditions

2008). Around 70% of patients are diagnosed with ES-SCLC, 2015), 2016). It displays a distinct natural history characterized by a high growth fraction, accounting for 10% to 15% of lung cancer (Rudin et al, Extensive stage small cell lung cancer (ES-SCLC). Small-cell lung cancer, is an aggressive lung cancer subtype with neuroendocrine differentiation and strongly associated with smoking (Koinis et al, presenting with distant metastasis or tumor or nodal volume that is too large to be encompassed in a tolerable radiation plan., rapid doubling time and early establishment of widespread metastatic lesions (Gustafsson et al

Brief summary

OS

Detailed description

PFS, OR, DC, DOR, PFS rate at 6 months, 1 year, and 2 years from randomization OS rate at 6 months, 1 year, 2 years, and 3 years from randomization TTP, Incidence of treatment-emergent adverse events, Serum concentrations of tarlatamab., Incidence of anti-tarlatamab antibody formation.

Interventions

DRUGTarlatamab
DRUGETOPOSIDE
DRUGDURVALUMAB
DRUGCARBOPLATIN
DRUGINFLIXIMAB
DRUGSILTUXIMAB
DRUGMYCOPHENOLATE MOFETIL

Sponsors

Amgen Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
OS

Secondary

MeasureTime frame
PFS, OR, DC, DOR, PFS rate at 6 months, 1 year, and 2 years from randomization OS rate at 6 months, 1 year, 2 years, and 3 years from randomization TTP, Incidence of treatment-emergent adverse events, Serum concentrations of tarlatamab., Incidence of anti-tarlatamab antibody formation.

Countries

Austria, Belgium, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Spain

Outcome results

None listed

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