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Clinical Trials List

Protocol Number20240178
NCT Number(ClinicalTrials.gov Identfier)NCT07005128
Not yet recruiting

2025-05-09 - 2030-07-15

Phase III

Recruiting2

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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)

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/03/01

Investigators and Locations

Principal Investigator Chi-Lu Chiang Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Small-cell Lung Cancer、 Extensive Stage Small-cell Lung Cancer

Objectives

The aim of this trial is to gain a deeper understanding of the combination of tarlatamab, durvalumab, carboplatin, and etoposide, compared to the current first-line standard of care of durvalumab, carboplatin, and etoposide, in patients with untreated metastatic small cell lung cancer (ES-SCLC). This disease is characterized by cancerous growth in lung tissue that has spread to other parts of the body or has become too large for radiation therapy. The trial will observe whether tarlatamab combined with current first-line standard of care can help extend the survival of untreated ES-SCLC patients. Researchers also hope to investigate the safety of this treatment, its ability to improve survival, and whether it causes any side effects.

Test Drug

凍晶乾燥注射劑
凍晶乾燥注射劑

Active Ingredient

1013010800

Dosage Form

245
245

Dosage

1mg/ml
10 mg/vial

Endpoints

• OS is defined as the time from random assignment until death from any cause.

Inclution 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

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.

The Estimated Number of Participants

  • Taiwan

    8 participants

  • Global

    330 participants

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