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Recruiting NCT06598306

Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

Phase I Interventional Extensive Stage Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tarlatamab.
Who it may be relevant to
Registry conditions: Extensive Stage Small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Belgium, China, Germany +5
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Subcutaneous Tarlatamab in Subjects With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

Overview

The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.

Interventions

  • Drug Tarlatamab
    Administered by SC injection.

Primary outcome measures

  • Number of Participants with Dose-limiting toxicities (DLTs) [Time frame: Up to day 21]
  • Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Time frame: Up to approximately 24 months]
  • Number of Participants with Changes in Vital Signs [Time frame: Up to approximately 24 months]
  • Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests [Time frame: Up to approximately 24 months]
Secondary outcome measures (12)
  • Maximum Serum Concentration (Cmax) of Tarlatamab [Time frame: Up to approximately 12 months]
  • Serum Concentration Prior to Dosing (Ctrough) of Tarlatamab [Time frame: Up to approximately 12 months]
  • Time to Cmax (Tmax) of Tarlatamab [Time frame: Up to approximately 12 months]
  • Area Under the Concentration-time Curve (AUC) of Tarlatamab [Time frame: Up to approximately 12 months]
  • Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [Time frame: Up to approximately 24 months]
  • Duration of Response (DOR) per RECIST 1.1 [Time frame: Up to approximately 24 months]
  • Time to Response (TTR) per RECIST 1.1 [Time frame: Up to approximately 24 months]
  • Progression-free Survival (PFS) per RECIST 1.1 [Time frame: Up to approximately 24 months]
  • Time to Progression per RECIST 1.1 [Time frame: Up to approximately 24 months]
  • Time to Subsequent Therapy [Time frame: Up to approximately 24 months]
  • Overall Survival (OS) [Time frame: Up to approximately 24 months]
  • Number of Participants with Anti-tarlatamab Antibody Formation [Time frame: Up to approximately 24 months]

Eligibility criteria

Inclusion criteria

  • Participants ≥ 18 years of age (or ≥ legal adult age within country if it is older than 18 years) at time of signing informed consent.
  • Participants with histologically or cytologically confirmed ES-SCLC that progressed or recurred following at least one line of platinum-based anti-cancer therapy for SCLC.

Note: Participants with prior treatment for LS-SCLC should have also received another regimen for their recurrent, ES-SCLC disease.

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
  • Participants must have adequate organ function (cardiac, pulmonary, kidney, and liver).
  • Participants must be able to have SC injections administered in the abdomen.
  • Participants without measurable disease or tumor tissue (fresh biopsy or archival) available may be permitted after discussion with and approval by Amgen Medical Monitor.

Exclusion criteria

  • Participants that have received prior DLL3 targeted therapy.
  • Participants with untreated or symptomatic brain metastases or those requiring therapy with steroids.
  • Note: Participants with asymptomatic brain metastatic lesions are allowed following definitive treatment (Amgen Medical Monitor may approve untreated, asymptomatic brain metastasis if local therapy is not required per investigator judgment).
  • Participants with leptomeningeal disease.
  • Participants with baseline oxygen requirement.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 6 centers
  • University of Southern California, Norris Comprehensive Cancer Center — Los Angeles
  • University of Illinois Chicago — Chicago
  • Trinity Health Saint Joseph Mercy Ann Arbor — Ann Arbor
  • Avera Cancer Institute — Sioux Falls
  • University of Texas MD Anderson Cancer Center — Houston
  • Swedish Cancer Institute — Seattle
Spain · 4 centers
  • Hospital Regional Universitario de Malaga — Málaga
  • Hospital Universitari Vall d Hebron — Barcelona
  • Hospital Universitari i Politecnic La Fe — Valencia
  • Hospital Universitario 12 de Octubre — Madrid
Australia · 3 centers
  • Chris OBrien Lifehouse — Camperdown
  • Calvary Mater Newcastle Hospital — Waratah
  • The Alfred Hospital — Melbourne
Belgium · 3 centers
  • Universitair Ziekenhuis Gent — Ghent
  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg — Leuven
  • Centre Hospitalier Universitaire de Liege - Sart Tilman — Liège
Poland · 3 centers
  • Uniwersyteckie Centrum Kliniczne — Gdansk
  • Instytut Centrum Zdrowia Matki Polki — Lodz
  • Wojewodzki Szpital im Sw Ojca Pio w Przemyslu — Przemyśl
Switzerland · 3 centers
  • Kantonsspital Graubuenden — Chur
  • Freiburg Spital — Fribourg
  • Kantonsspital Winterthur — Winterthur
Turkey (Türkiye) · 3 centers
  • Adana Sehir Egitim ve Arastirma Hastanesi — Adana
  • Ankara Bilkent Sehir Hastanesi — Ankara
  • Koc Universitesi Hastanesi — Istanbul
China · 2 centers
  • Jilin Cancer Hospital — Changchun
  • Shanghai Pulmonary Hospital — Shanghai
Germany · 2 centers
  • Universitaetsklinikum Regensburg — Regensburg
  • Universitaetsklinikum Wuerzburg — Würzburg
Japan · 2 centers
  • Okayama University Hospital — Okayama
  • Wakayama Medical University Hospital — Wakayama

Identifiers

NCT: NCT06598306 · 20230298

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗