NCT05740566

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 509 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS).

Conditions

• Small Cell Lung Cancer (SCLC)

Interventions

Type	Name	Description
DRUG	Tarlatamab	Tarlatamab will be administered as an IV infusion.
DRUG	Lurbinectedin	Lurbinectedin will be administered per local SOC.
DRUG	Topotecan	Topotecan will be administered per local SOC.
DRUG	Amrubicin	Amrubicin will be administered per local SOC.

Timeline

• Start date: 2023-05-31
• Primary completion: 2025-01-29
• Completion: 2028-03-26
• First posted: 2023-02-23
• Last updated: 2026-01-05
• Results posted: 2026-01-05

Locations

223 sites across 31 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Portugal, Romania, Singapore, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study