Phase 2, Multicenter, Open label, Platform Study investigating Tarlatamab (AMG 757) in patients with Metastatic/Locally Advanced Small-Cell Lung Cancer (SCLC) and Other Poorly Differentiated Neuroendocrine Carcinomas (NECs), with biomarker analysis to characterize response/resistance (UNLOCK TARLATAMAB)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515847-47-00

Acronym

CSET 2024/4014

Enrollment

Registered

2025-04-23

Start date

2025-06-24

Completion date

Unknown

Last updated

2025-09-26

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

Conditions

Metastaic small cell lung cancer (SCLC) and other poorly differentitated neuroendocrine carcinomas (NECs)

Brief summary

Objective response rate (ORR) at 4 months.

Detailed description

Objective response rate (ORR) at different timepoints - Duration of response (DOR) - Clinical benefit rate (CBR) - Progression-free survival (PFS), Frequency and severity of any AEs, TEAEs, SAEsgraded by NCI-CTCAE v5.0; frequency and severity of CRS and ICANS graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria (Lee et al, 2019); proportion of treatment discontinuations, interruptions, and dose reductions due to any AEs; frequency and severity of laboratory abnormalities defined by NCI-CTCAE v5.0;The use of immune modulating concomitant medication will be also summarized

Interventions

DRUGTarlatamab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective response rate (ORR) at 4 months.	—

Secondary

Measure	Time frame
Objective response rate (ORR) at different timepoints - Duration of response (DOR) - Clinical benefit rate (CBR) - Progression-free survival (PFS), Frequency and severity of any AEs, TEAEs, SAEsgraded by NCI-CTCAE v5.0; frequency and severity of CRS and ICANS graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria (Lee et al, 2019); proportion of treatment discontinuations, interruptions, and dose reductions due to any AEs; frequency and severity of laboratory abnormalities defined by NCI-CTCAE v5.0;The use of immune modulating concomitant medication will be also summarized	—

Measure

Time frame

—

Countries

France, Germany

Outcome results

None listed

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