Study Complete
Sponsor ID
20200439
AMG 757 and AMG 404 in Subjects with Small Cell Lung Cancer (SCLC)
Study Details
The main purpose of this study is to evaluate the safety, tolerability, and recommended phase 2 target dose of tarlatamab in combination with AMG 404.
Protocol Summary
Primary Outcome Measures
Number of Participants with a Dose Limiting Toxicity (DLT)
Timeframe: 28 days
Number of Participants with a Treatment-emergent Adverse Event (TEAE)
Timeframe: 24 months
Number of Participants with a Treatment-related Adverse Event
Timeframe: 24 months
Number of Participants with a Clinically Significant Change from Baseline in Vital Signs
Timeframe: Baseline to Month 24
Number of Participants with a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Measurements
Timeframe: Baseline to Month 24
Number of Participants with a Clinically Significant Change from Baseline in Clinical Laboratory Tests
Timeframe: Baseline to Month 24
Secondary Outcome Measures
Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Timeframe: 24 months
Duration of Response (DOR)
Timeframe: 24 months
Disease Control Rate (DCR)
Timeframe: 24 months
Progression-free Survival (PFS)
Timeframe: 24 months
Overall Survival (OS)
Timeframe: 24 months
Maximum Observed Concentration (Cmax) of Tarlatamab in Combination with AMG 404
Timeframe: 24 months
Minimum Observed Concentration (Cmin) of Tarlatamab in Combination with AMG 404
Timeframe: 24 months
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Tarlatamab in Combination with AMG 404
Timeframe: 24 months
Locations
Location
Tennessee Oncology, PLLC
Nashville, TN, United States, 37203
Status
Recruiting
Location
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
Status
Recruiting
Location
University Hospitals Cleveland Medical Center
Cleveland, OH, United States, 44106
Status
Recruiting
Location
Medizinische Universitaet Innsbruck
Innsbruck, Austria, 6020
Status
Recruiting
Location
Wake Forest Baptist Comprehensive Cancer Research Center
Winston Salem, NC, United States, 27157
Status
Recruiting
Location
Taipei Veterans General Hospital
Taipei, Taipei, Taiwan, 11217
Status
Recruiting
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