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A single-arm phase II-study to confirm efficacy and feasibility of tarlatamab treatment in patients with extensive stage small-cell lung cancer with poor performance status (SPACE-T) [without IMPD-Q]

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522437-65-00
Acronym
AIO-TRK-0624
Enrollment
57
Registered
2025-10-31
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-11

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

Conditions

small-cell lung cancer

Brief summary

Overall survival (OS) rate at 12 months

Detailed description

Overall survival (OS), Progression-free survival (PFS), Objective response rate (ORR) (RECIST v1.1), intracranial ORR (RECIST v1.1), Rate of patients tolerating tarlatamab until first disease assessment, Time to next-line systemic therapy, Safety and tolerability, Quality of life: o EORTC-QLQ-C30 o PRO CTCAE

Interventions

DRUGTarlatamab

Sponsors

AIO-Studien gGmbH
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Overall survival (OS) rate at 12 months

Secondary

MeasureTime frame
Overall survival (OS), Progression-free survival (PFS), Objective response rate (ORR) (RECIST v1.1), intracranial ORR (RECIST v1.1), Rate of patients tolerating tarlatamab until first disease assessment, Time to next-line systemic therapy, Safety and tolerability, Quality of life: o EORTC-QLQ-C30 o PRO CTCAE

Countries

Germany

Outcome results

None listed

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