Summary

Eligibility
for people ages 18-99 (full criteria)
Location
at UCLA
Dates
study started
study ends around

Description

Summary

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).

Official 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)

Keywords

Small-cell Lung Cancer, Extensive Stage Small-cell Lung Cancer, Small Cell Lung Carcinoma, AMG 757, durvalumab, Carboplatin, Etoposide, Tarlatamab, Tarlatamab + Durvalumab + Carboplatin + Etoposide, Durvalumab + Carboplatin + Etoposide

Eligibility

You can join if…

Open to people ages 18-99

  • 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.

You CAN'T join if...

  • 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

  • University of California Los Angeles accepting new patients
    Santa Monica California 90404 United States
  • Presbyterian Intercommunity Hospital Health Whitter Hospital accepting new patients
    Whittier California 90602 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website
ID
NCT07005128
Phase
Phase 3 Lung Cancer Research Study
Study Type
Interventional
Participants
Expecting 330 study participants
Last Updated