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Recruiting
Sponsor ID
20240178

A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)DeLLphi-312

Sponsor ID
20240178
Clinicaltrials.gov ID
NCT07005128
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The main objective of the study is to compare the efficacy of tarlatamab in combination with durvalumab, carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide on prolonging overall survival (OS).

Additional Study Details

Phase
Phase 3
Product
Tarlatamab
Type
Interventional
Masking
None (Open Label)
Enrollment
330
Additional Study Details

Protocol Summary

Primary Outcome Measures

Overall Survival (OS)

Timeframe: Up to approximately 3.5 years

Progression free survival (PFS) (Blinded Independent Central Review [BICR] Assessed)

Timeframe: Up to approximately 3.5 years

Secondary Outcome Measures

PFS (Investigator Assessed)

Timeframe: Up to approximately 4 years

Objective Response (OR)

Timeframe: Up to approximately 4 years

Disease Control

Timeframe: Up to approximately 4 years

Duration of Response (DOR)

Timeframe: Up to approximately 4 years

PFS Rate

Timeframe: 6 months, 1 year, and 2 years

OS Rate

Timeframe: 6 months, 1 year, 2 years and 3 years

Time to Progression

Timeframe: Up to approximately 4 years

Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to approximately 4 years

Number of Participants Who Experience Treatment-related Adverse Events

Timeframe: Up to approximately 4 years

Number of Participants Who Experience Events of Interest

Timeframe: Up to approximately 4 years

Serum Concentrations of Tarlatamab

Timeframe: Up to approximately 1 year

Number of Participant Who Develop Anti-Tarlatamab Antibodies

Timeframe: Up to 13 months

Locations

Location
Status
Contact Us
Location
Baptist Cancer Center
Memphis, TN, United States, 38120
Status
Recruiting
Location
Monash Medical Centre
Clayton, VIC, Australia, 3168
Status
Recruiting
Location
Bagcilar Medipol Mega Universite Hastanesi
Istanbul, Turkey, 34214
Status
Recruiting
Location
Chris OBrien Lifehouse
Camperdown, NSW, Australia, 2050
Status
Recruiting
Location
Kyushu University Hospital
Fukuoka-shi, Fukuoka, Japan, 812-8582
Status
Recruiting
Location
Shanghai Chest Hospital
Shanghai, Shanghai, China, 200030
Status
Recruiting
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Study Info
Age
18 - 99 Years
Condition
  • Lung Cancer - Small Cell
    • Sex
    All
    Trial Dates
    Aug 2025 - Jan 2029
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Participant has provided informed consent before initiation of any study-specific activities/procedures. - Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years. - Histologically or cytologically documented ES-SCLC (American Joint Committee on Cancer, 2017, Stage IV SCLC [T any, N any, M1 a/b/c]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. - Measurable disease as defined per RECIST 1.1. - Suitable to receive carboplatin, etoposide and durvalumab regimen as first-line treatment per investigator clinical assessment. - Minimum life expectancy ≥ 12 weeks.
    Exclusion Criteria:
    - Participants can have no history of other malignancy in the last 2 years. - Any symptomatic central nervous system (CNS) metastases, or leptomeningeal disease. - They will have no history of severe or life-threatening events to immune-mediated therapy. - History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment. - They will have no active autoimmune or inflammatory disorders. - Presence of active human immunodeficiency virus (HIV) or active Hepatitis (B/C) infection. - Evidence or interstitial lung disease (ILD) or active, non-infectious pneumonitis. - History of solid organ transplant. - They will not have had a myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months prior to first dose of study treatment.