NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT07005128

RecruitingPhase 3

Sponsor: Amgen

Conditions: Small-cell Lung Cancer, Extensive Stage Small-cell Lung Cancer

Interventions: Tarlatamab, Durvalumab, Carboplatin, Etoposide

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, China, Denmark

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 overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (164)

Casa Grande, Arizona, United States
Goodyear, Arizona, United States
Hot Springs, Arkansas, United States
Jonesboro, Arkansas, United States
Fullerton, California, United States
Los Angeles, California, United States
Santa Monica, California, United States
Whittier, California, United States
Grand Junction, Colorado, United States
New Britain, Connecticut, United States
New Haven, Connecticut, United States
Norwich, Connecticut, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Kissimmee, Florida, United States
Macon, Georgia, United States
Newnan, Georgia, United States
Chicago, Illinois, United States
Decatur, Illinois, United States
Rockford, Illinois, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Wichita, Kansas, United States
Westbrook, Maine, United States
Boston, Massachusetts, United States
Edina, Minnesota, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
Hattiesburg, Mississippi, United States
Lincoln, Nebraska, United States
+ 134 more on CT.gov