Recruiting
Sponsor ID
20250114

Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)DeLLphi-313

Sponsor ID
20250114
Clinicaltrials.gov ID
NCT07531095
EUCTIS ID
2025-522888-15-00
EudraCT ID
N/A

Study Details

The primary objective of this trial is to evaluate the safety and tolerability of tarlatamab in combination with ZL-1310 with or without durvalumab and to determine the maximum tolerated combination dose (MTCD) and/or recommended phase 2 dose (RP2D) of ZL-1310 in combination with tarlatamab.

Additional Study Details

Phase
Phase 1
Product
Tarlatamab
Type
Interventional
Masking
None (Open Label)
Enrollment
160
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to 3.5 years

Parts 1 and 3: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)

Timeframe: Up to Day 21

Secondary Outcome Measures

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Timeframe: Up to 3.5 years

Duration of Response (DOR) per RECIST v1.1

Timeframe: Up to 3.5 years

Time to Response (TTR) per RECIST v1.1

Timeframe: Up to 3.5 years

Disease Control Rate (DCR) per RECIST v1.1

Timeframe: Up to 3.5 years

Progression-free Survival (PFS) per RECIST v1.1

Timeframe: Up to 3.5 years

Time to Progression (TTP) per RECIST v1.1

Timeframe: Up to 3.5 years

Time to Subsequent Therapy

Timeframe: Up to 3.5 years

Overall survival (OS)

Timeframe: Up to 3.5 years

Serum Tarlatamab Concentrations

Timeframe: Up to Week 36

Locations

Location
Status
Contact Us
Location
Baptist Cancer Center
Memphis, TN, United States, 38120
Status
Recruiting
Location
New York University Cancer Institute
New York, NY, United States, 10016
Status
Recruiting
Location
Next Virginia
Fairfax, VA, United States, 22031
Status
Recruiting
Location
Izmir Ekonomi Universitesi Medical Point Hastanesi
Izmir, Turkey, 35575
Status
Recruiting
Location
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, Turkey, 06230
Status
Recruiting
Location
Adana Sehir Egitim ve Arastirma Hastanesi
Adana, Turkey, 01370
Status
Recruiting
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