Recruiting 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)

Phase III Interventional Small-cell Lung Cancer Extensive Stage Small-cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Tarlatamab, Durvalumab, Carboplatin, Etoposide.
Who it may be relevant to: Registry conditions: Small-cell Lung Cancer, Extensive Stage Small-cell Lung Cancer. Basic parameters: 18 years — 99 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +21
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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).

Interventions

Drug Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Drug Durvalumab
Durvalumab will be administered as an IV infusion.
Drug Carboplatin
Carboplatin will be administered as an IV infusion.
Drug Etoposide
Etoposide will be administered as an IV infusion.

Primary outcome measures

Overall Survival (OS) [Time frame: Up to approximately 3.5 years]
Progression free survival (PFS) (Blinded Independent Central Review [BICR] Assessed) [Time frame: Up to approximately 3.5 years]

Secondary outcome measures (12)

PFS (Investigator Assessed) [Time frame: Up to approximately 4 years]
Objective Response (OR) [Time frame: Up to approximately 4 years]
Disease Control [Time frame: Up to approximately 4 years]
Duration of Response (DOR) [Time frame: Up to approximately 4 years]
PFS Rate [Time frame: 6 months, 1 year, and 2 years]
OS Rate [Time frame: 6 months, 1 year, 2 years and 3 years]
Time to Progression [Time frame: Up to approximately 4 years]
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) [Time frame: Up to approximately 4 years]
Number of Participants Who Experience Treatment-related Adverse Events [Time frame: Up to approximately 4 years]
Number of Participants Who Experience Events of Interest [Time frame: Up to approximately 4 years]
Serum Concentrations of Tarlatamab [Time frame: Up to approximately 1 year]
Number of Participant Who Develop Anti-Tarlatamab Antibodies [Time frame: Up to 13 months]

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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 50 centers

Cancer and Blood Specialists of Arizona — Casa Grande
City of Hope Cancer Center Phoenix — Goodyear
Genesis Cancer Center — Hot Springs
Saint Bernards Medical Center — Jonesboro
Providence Saint Jude Medical Center — Fullerton
Translational Research in Oncology US Inc, Trio Central Pharmacy — Los Angeles
University of California Los Angeles — Santa Monica
Presbyterian Intercommunity Hospital Health Whitter Hospital — Whittier
… and 42 more centers

China · 17 centers

Beijing Cancer Hospital — Beijing
Beijing Cancer Hospital — Beijing
The Second Attached Hospital Of Fujian Medical University — Quanzhou
Harbin Medical University Cancer Hospital — Harbin
Jiamusi Cancer Hospital — Jiamusi
Henan Cancer Hospital — Zhengzhou
Jiangxi Cancer hospital — Nanchang
The First Affiliated Hospital of Nanchang University — Nanchang
… and 9 more centers

Japan · 13 centers