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)

Sponsor ID
20200469
Clinicaltrials.gov ID
NCT05361395
EUCTIS ID
N/A
EudraCT ID
2024-511021-58

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.

Additional Study Details

Phase
Phase 1
Product
Tarlatamab
Type
Interventional
Masking
None (Open Label)
Enrollment
184
Additional Study Details

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
Status
Contact Us
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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