Extensive Stage Small-cell Lung Cancer, Small-cell Lung Cancer
Conditions
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).
Interventions
DRUGTarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
DRUGDurvalumab
Durvalumab will be administered as an IV infusion.
DRUGCarboplatin
Carboplatin will be administered as an IV infusion.
DRUGEtoposide
Etoposide will be administered as an IV infusion.
Sponsors
Amgen
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | Up to approximately 3.5 years |
| Progression free survival (PFS) (Blinded Independent Central Review [BICR] Assessed) | Up to approximately 3.5 years |
Secondary
| Measure | Time frame |
|---|---|
| PFS (Investigator Assessed) | Up to approximately 4 years |
| Objective Response (OR) | Up to approximately 4 years |
| Disease Control | Up to approximately 4 years |
| Duration of Response (DOR) | Up to approximately 4 years |
| PFS Rate | 6 months, 1 year, and 2 years |
| OS Rate | 6 months, 1 year, 2 years and 3 years |
| Time to Progression | Up to approximately 4 years |
| Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) | Up to approximately 4 years |
| Number of Participants Who Experience Treatment-related Adverse Events | Up to approximately 4 years |
| Number of Participants Who Experience Events of Interest | Up to approximately 4 years |
| Serum Concentrations of Tarlatamab | Up to approximately 1 year |
| Number of Participant Who Develop Anti-Tarlatamab Antibodies | Up to 13 months |
Countries
Argentina, Australia, Austria, Belgium, Brazil, China, Denmark, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Romania, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United States
Contacts
STUDY_DIRECTORMD
Amgen
Outcome results
None listed