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A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Tarlatamab Therapy in Subjects With Limited-Stage Small-Cell Lung Cancer (LS SCLC) who Have not Progressed Following Concurrent Chemoradiation Therapy (DeLLphi-306)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506235-15-00
Acronym
20230016
Enrollment
145
Registered
2024-06-03
Start date
2024-11-07
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Limited-Stage Small-Cell Lung Cancer (LS SCLC)

Brief summary

PFS (BICR), OS

Detailed description

PFS (investigator), OR, DC and DOR, "PFS and OS rate at 6 months, 1 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 after randomization, Serum concentration of tarlatamab, Incidence of anti-tarlatamab antibody formation

Interventions

DRUGTarlatamab
DRUGTOCILIZUMAB
DRUGVASOPRESSIN (ARGIPRESSIN)
DRUGDEXAMETHASONE
DRUGPARACETAMOL
DRUGSILTUXIMAB
DRUGPREDNISOLONE
DRUGPlacebo for Tarlatamab (AMG-757)

Sponsors

Amgen Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
PFS (BICR), OS

Secondary

MeasureTime frame
PFS (investigator), OR, DC and DOR, "PFS and OS rate at 6 months, 1 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 after randomization, Serum concentration of tarlatamab, Incidence of anti-tarlatamab antibody formation

Countries

Austria, Belgium, Bulgaria, France, Germany, Greece, Italy, Poland, Portugal, Romania, Spain, Sweden

Outcome results

None listed

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