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

ConditionsSmall-cell Lung CancerExtensive Stage Small-cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorAmgen

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tarlatamab

    Drug

    Tarlatamab will be administered as an intravenous (IV) infusion.

  • Durvalumab

    Drug

    Durvalumab will be administered as an IV infusion.

  • Carboplatin

    Drug

    Carboplatin will be administered as an IV infusion.

  • Etoposide

    Drug

    Etoposide will be administered as an IV infusion.

Treatment groups

330 Participants
are divided into 2 treatment groups
Group A: Tarlatamab + Durvalumab + Carboplatin + EtoposideExperimental treatment 4 interventions
Group B: Durvalumab + Carboplatin + EtoposideActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

Time frame
Up to approximately 3.5 years
2

Progression free survival (PFS) (Blinded Independent Central Review [BICR] Assessed)

Time frame
Up to approximately 3.5 years

Secondary outcomes

1

PFS (Investigator Assessed)

Time frame
Up to approximately 4 years
2

Objective Response (OR)

Time frame
Up to approximately 4 years
3

Disease Control

Time frame
Up to approximately 4 years
4

Duration of Response (DOR)

Time frame
Up to approximately 4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amgen

Lead sponsor

AstraZeneca

Collaborator

Source ClinicalTrials.gov
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