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A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects with Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment (DeLLphi-301).

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511837-37-00
Acronym
20200491
Enrollment
113
Registered
2024-10-09
Start date
2021-12-21
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Relapsed/Refractory Small Cell Lung Cancer

Brief summary

Part 1 only - objective response (OR) (complete response [CR] and partial response [PR]) •incidence of treatment-emergent adverse events (TEAEs) •serum concentrations of Tarlatamab, Part 1 and 2 - OR (CR and PR), Part 3 - Incidence of TEAEs

Detailed description

duration of response (DOR), disease control (DC), duration of DC, progression-free survival (PFS), DOR, overall survival (OS), incidence of TEAEs, serum concentrations of Tarlatamab, incidence of anti-Tarlatamab antibody formation

Interventions

DRUGTarlatamab
DRUGTARLATAMAB
DRUGSILTUXIMAB

Sponsors

Amgen Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part 1 only - objective response (OR) (complete response [CR] and partial response [PR]) •incidence of treatment-emergent adverse events (TEAEs) •serum concentrations of Tarlatamab, Part 1 and 2 - OR (CR and PR), Part 3 - Incidence of TEAEs

Secondary

MeasureTime frame
duration of response (DOR), disease control (DC), duration of DC, progression-free survival (PFS), DOR, overall survival (OS), incidence of TEAEs, serum concentrations of Tarlatamab, incidence of anti-Tarlatamab antibody formation

Countries

Austria, Belgium, Denmark, France, Germany, Greece, Italy, Poland, Spain

Outcome results

None listed

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