At a glance
ClinicalIndex Comparison RecordPhase 3Active· 509 enrolled
Drug / intervention
Tarlatamab +3 moredrug
Likely dose
Not stated in record
Key inclusion· 7
- ✓Histologically or cytologically confirmed SCLC with progression or relapse
- ✓Relapse or progression after exactly one prior platinum-based regimen
- ✓Measurable disease by RECIST 1.1 within 21 days of screening
- ✓ECOG performance status 0 or 1
Key exclusion· 13
- ✕Symptomatic CNS metastases (with protocol-defined exceptions)
- ✕Leptomeningeal disease
- ✕Prior checkpoint inhibitor therapy with serious events as defined in protocol
- ✕Active autoimmune disease requiring systemic treatment (except replacement) within 2 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Tarlatamab, Lurbinectedin, and 2 other interventions for Small Cell Lung Cancer (SCLC). Active but no longer recruiting, targeting 509 participants across 223 sites in 31 countries.
Detailed Summary
The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall Cell Lung Cancer (SCLC)
CountriesArgentina, 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, United States
Collaborators--
Timeline
Phase 3Active
20242025202620272028
First PostedFeb 2023
Enrollment StartMay 2023
Primary CompletionJan 2025
TodayJul 2026
Study CompletionMar 2028
First PostedFeb 23, 2023
Enrollment StartMay 31, 2023
Primary CompletionJan 29, 2025
Study CompletionMar 26, 2028
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 3.4 years ago
Interventions
Tarlatamabdrug
Tarlatamab will be administered as an IV infusion.
Lurbinectedindrug
Lurbinectedin will be administered per local SOC.
Topotecandrug
Topotecan will be administered per local SOC.
Amrubicindrug
Amrubicin will be administered per local SOC.