Recruitment Complete
Sponsor ID
20200469
First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects with Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Study Details
This is a phase 1b study to assess the safety and tolerability of tarlatamab in combination with programmed death ligand (PD-L1) inhibition with and without chemotherapy.
Protocol Summary
Primary Outcome Measures
Number of Participants with a Dose Limiting Toxicity (DLT)
Timeframe: 24 months
Number of Participants with Treatment-emergent Adverse Events (TEAE)
Timeframe: 24 months
Number of Participants with Treatment-related Adverse Events
Timeframe: 24 months
Number of Participants with Clinically Significant Changes in Vital Signs
Timeframe: 24 months
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements
Timeframe: 24 months
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Timeframe: 24 months
Secondary Outcome Measures
6-month Progression-free Survival (PFS)
Timeframe: 24 months
Objective Response (OR)
Timeframe: 24 months
Duration of Response (DOR)
Timeframe: 24 months
Disease Control Rate(DCR)
Timeframe: 24 months
Overall Survival (OS)
Timeframe: 24 months
Serum Concentration of Tarlatamab
Timeframe: 24 months
Locations
Location
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, Japan, 135-8550
Status
Recruiting
Location
Hospital Universitari Vall d Hebron
Barcelona, Cataluña, Spain, 08035
Status
Recruiting
Location
Inselspital Bern
Bern, Switzerland, 3010
Status
Recruiting
Location
Chris OBrien Lifehouse
Camperdown, NSW, Australia, 2050
Status
Recruiting
Location
Universitaetsklinikum Dresden
Dresden, Germany, 01307
Status
Recruiting
Location
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan, 277-8577
Status
Recruiting
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