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NCT Number: 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)

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).

Recruiting

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cemic, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tarlatamab

Drug

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

Other names: AMG 757, Imdelltra

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.

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

  5. PFS Rate

    Time frame: 6 months, 1 year, and 2 years

  6. OS Rate

    Time frame: 6 months, 1 year, 2 years and 3 years

  7. Time to Progression

    Time frame: Up to approximately 4 years

  8. Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to approximately 4 years

  9. Number of Participants Who Experience Treatment-related Adverse Events

    Time frame: Up to approximately 4 years

  10. Number of Participants Who Experience Events of Interest

    Time frame: Up to approximately 4 years

  11. Serum Concentrations of Tarlatamab

    Time frame: Up to approximately 1 year

  12. Number of Participant Who Develop Anti-Tarlatamab Antibodies

    Time frame: Up to 13 months

Study contacts

Contact information is provided by the study sponsor or research team.

Amgen Call Center

CONTACT

[email protected]

866-572-6436

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Collaborators

  • AstraZeneca

Registry information

Official study 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)

Acronym: DeLLphi-312

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jun 5, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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