A Study for Extensive Stage Small-Cell Lung Cancer

This study is looking at new ways to treat extensive stage small-cell lung cancer (ES-SCLC). It compares two treatment approaches: one using tarlatamab, durvalumab, carboplatin, and etoposide, and another using durvalumab, carboplatin, and etoposide. All these medications are given through an IV (intravenous) infusion. The main goal is to see if adding tarlatamab helps people live longer (overall survival) and if it slows down the cancer's growth (progression-free survival). The study plans to enroll about 330 participants aged 18 to 99 years old who have been diagnosed with ES-SCLC. The current status of the study is unclear.

Study design
This study is an interventional trial designed to compare two different treatment combinations. It aims to enroll approximately 330 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for overall survival and progression-free survival for up to approximately 3.5 years.

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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)

Recruiting
PHASE3Ages 18–99InterventionalTreatment
Amgen
~330 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:TarlatamabDurvalumabCarboplatinEtoposide

At a glance

Recruiting sites
152 of 164 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival (OS)
Measured over Up to approximately 3.5 years
+1 more outcome measured
Small-cell Lung Cancer
Extensive Stage Small-cell Lung Cancer
164 sites across 77 states
Germany10
France7
Italy6
Turkey (Türkiye)6
Texas5
California4
Belgium4
Greece4
  • MD · STUDY_DIRECTOR · Amgen

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Eligibility criteria

Inclusion

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

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.
  • 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