Clinical trial NCT07005128: A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)
Official title: A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in Combination With Durvalumab, Carboplatin and Etoposide Versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Small-cell Lung Cancer
Extensive Stage Small-cell Lung Cancer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2025-06-05
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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 previous diagnosis of transformed non-small-cell lung cancer (NSCLC), epidermal growth factor receptor activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology.
* 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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 3.5 years
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: Up to approximately 4 years
measure: Objective Response (OR)
timeFrame: Up to approximately 4 years
measure: Disease Control
timeFrame: Up to approximately 4 years
measure: Duration of Response (DOR)
timeFrame: Up to approximately 4 years
measure: PFS Rate
timeFrame: 6 months, 1 year, and 2 years
measure: OS Rate
timeFrame: 6 months, 1 year, and 2 years
measure: Time to Progression
timeFrame: Up to approximately 4 years
measure: Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to approximately 4 years
measure: Number of Participants Who Experience Treatment-related Adverse Events
timeFrame: Up to approximately 4 years
measure: Number of Participants Who Experience Events of Interest
timeFrame: Up to approximately 4 years
measure: Serum Concentrations of Tarlatamab
timeFrame: Up to approximately 1 year
measure: Number of Participant Who Develop Anti-Tarlatamab Antibodies
timeFrame: Up to 13 months
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: