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

Sponsor ID
20230273
Clinicaltrials.gov ID
NCT06502977
EUCTIS ID
N/A
EudraCT ID
N/A

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).

Additional Study Details

Phase
Phase 2
Product
Tarlatamab
Type
Interventional
Masking
None (Open Label)
Enrollment
32
Additional Study Details

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
Status
Contact Us
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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