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A Randomized, Open-label, Phase 3 Study of Tarlatamab Compared With Standard of Care in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy (DeLLphi-304)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502669-14-00
Acronym
20210004
Enrollment
199
Registered
2023-06-30
Start date
2023-12-18
Completion date
Unknown
Last updated
2026-01-22

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

Conditions

Small cell lung cancer (SCLC)

Brief summary

Overall Survival is defined as the length of time from start of treatment (tarlatamab or Standard Of Care) for the disease until death, due to any cause

Detailed description

The length of time the participants are grouped to receive either tarlatamab or Standard Of Care by chance until the disease has progressed or resulted in death, Change from Baseline PROs assessed 6-weekly over time to 18 weeks for Chest Pain, cough as measured by EORTC-QLQ-LC13; Tightening in the chest as measured by EORTC-QLQ-C30 and EORTC-QLQ-LC13; and Physical Function and Global Health Status of life as measured by EORTC-QLQ-C30

Interventions

DRUGDEXAMETHASONE
DRUGTOPOTECAN
DRUGSILTUXIMAB
DRUGTOCILIZUMAB
DRUGTarlatamab

Sponsors

Amgen Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Overall Survival is defined as the length of time from start of treatment (tarlatamab or Standard Of Care) for the disease until death, due to any cause

Secondary

MeasureTime frame
The length of time the participants are grouped to receive either tarlatamab or Standard Of Care by chance until the disease has progressed or resulted in death, Change from Baseline PROs assessed 6-weekly over time to 18 weeks for Chest Pain, cough as measured by EORTC-QLQ-LC13; Tightening in the chest as measured by EORTC-QLQ-C30 and EORTC-QLQ-LC13; and Physical Function and Global Health Status of life as measured by EORTC-QLQ-C30

Countries

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

Outcome results

None listed

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