Recruiting
Sponsor ID
20250046

Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum based First-line Chemotherapy (ES-SCLC)DeLLphi-315

Sponsor ID
20250046
Clinicaltrials.gov ID
NCT07778316
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objective of this study is to demonstrate non-inferiority in pharmacokinetic (PK) parameters of subcutaneous (SC) vs intravenous (IV) tarlatamab administration and to characterize the efficacy, safety, and tolerability of SC tarlatamab in participants with relapsed extensive-stage small-cell lung cancer (ES-SCLC) after platinum-based chemotherapy.

Additional Study Details

Phase
Phase 3
Product
Tarlatamab
Type
Interventional
Masking
None (Open Label)
Enrollment
400
Additional Study Details

Protocol Summary

Primary Outcome Measures

Area Under the Curve From Cycle 2 Day 1 to Day 15 (AUC C2D1-D15) of Tarlatamab

Timeframe: From Cycle 2 Day 1 to Day 15 (each cycle is 28 days)

Predose Concentration (Ctrough) of Tarlatamab

Timeframe: On Cycle 2 Day 15 (each cycle is 28 days)

Secondary Outcome Measures

Objective response (OR) per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)

Timeframe: Up to approximately 4 years

Progression free survival (PFS) per RECIST v1.1

Timeframe: Up to approximately 4 years

Duration of response (DOR) per RECIST v1.1

Timeframe: Up to approximately 4 years

Disease control (DC) per RECIST v1.1

Timeframe: Up to approximately 4 years

Overall survival (OS)

Timeframe: Up to approximately 4 years

Number of participants with treatment-emergent adverse events (TEAEs) and Treatment-related Adverse Events (TRAEs)

Timeframe: Up to approximately 4 years

Change from Baseline in Visual Analogue Scale (VAS) score of the EuroQol5 Dimension (EQ-5D-5L)

Timeframe: Up to approximately 4 years

Responses to Patient-Reported Adverse Events Questionnaire (PRO-CTCAE)

Timeframe: Up to approximately 4 years

Responses to Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire on symptom bother

Timeframe: Up to approximately 4 years

Responses to Therapy Administration Satisfaction Questionnaire (TASQ)

Timeframe: Up to approximately 4 years

Number of Participants with Anti-tarlatamab Antibody Formation

Timeframe: Up to approximately 4 years

Locations

Location
Status
Contact Us
Location
Cancer and Hematology Centers of Western Michigan
Grand Rapids, MI, United States, 49503
Status
Recruiting
Location
Shanghai Pulmonary Hospital
Shanghai, China, 200433
Status
Recruiting