Recruitment Complete
Sponsor ID
20230273
Study Evaluating Tarlatamab in Chinese Participants with Advanced Small Cell Lung Cancer after Two or More Prior Lines of TreatmentDeLLphi-307
Study Details
The primary aim of this study is to evaluate the efficacy of tarlatamab as
assessed by objective response rate (ORR) based on blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Protocol Summary
Primary Outcome Measures
ORR Based on BICR per RECIST 1.1
Timeframe: Approximately 24 months
Secondary Outcome Measures
Duration of Response (DOR) Based on BICR per RECIST 1.1
Timeframe: Approximately 24 months
Disease Control (DC) Based on BICR per RECIST 1.1
Timeframe: Approximately 24 months
Duration of DC Based on BICR per RECIST 1.1
Timeframe: Approximately 24 months
Progression-free Survival (PFS) Based on BICR per RECIST 1.1
Timeframe: Approximately 24 months
ORR Based on Investigator Assessment per RECIST 1.1
Timeframe: Approximately 24 months
DOR Based on Investigator Assessment per RECIST 1.1
Timeframe: Approximately 24 months
DC Based on Investigator Assessment per RECIST 1.1
Timeframe: Approximately 24 months
Duration of DC Based on Investigator Assessment per RECIST 1.1
Timeframe: Approximately 24 months
PFS Based on Investigator Assessment per RECIST 1.1
Timeframe: Approximately 24 months
Overall Survival (OS)
Timeframe: Approximately 24 months
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)
Timeframe: Approximately 24 months
Serum Concentration of Tarlatamab
Timeframe: Approximately 24 months
Number of Participants with Anti-tarlatamab Antibody Formation
Timeframe: Approximately 24 months
Locations
Location
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Status
Recruiting
Location
The Second Affiliated Hospital of Army Medical University, People's Liberation Army
Chongqing, Chongqing, China, 400037
Status
Recruiting
Location
Beijing Cancer Hospital
Beijing, Beijing, China, 100142
Status
Recruiting
Location
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Status
Recruiting
Location
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, China, 317000
Status
Recruiting
Location
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350025
Status
Recruiting
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