Fact CheckerSign in

NCT03319940Active, not recruitingPhase 1

Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)

A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of Tarlatamab in Subjects With Small Cell Lung Cancer (DeLLphi-300)

Source: ClinicalTrials.gov · Last updated 19 Nov 2025

Brief summary (registry, in English)

A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
269 (actual)
First submitted
5 Oct 2017
Start date
26 Dec 2017
Primary completion date
31 Dec 2026
Lead sponsor
Amgen
Diseases
Lung cancer
NCT number
NCT03319940
EU CT number
2023-506541-39-00
EudraCT number
2017-003421-15

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 269
  • From 26 Dec 2017 to the primary completion date, 31 Dec 2026
  • 35 sites in 13 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Major surgery within 28 days of first dose tarlatamab
  • Untreated (includes new lesions or progression in previously treated lesions) or symptomatic brain metastases and leptomeningeal disease (regardless of symptomatic or not).
  • Prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of tarlatamab with the following exceptions: participants who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade less than or equal to 1; and prior palliative radiotherapy must have been completed at least 7 days before the first dose of tarlatamab
  • Participants who experienced severe, life-threatening or recurrent (Grade 2 or higher) immune-mediated AEs or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immune-oncology agents
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab
  • Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of investigational product administration

Other illness

  • History of other malignancy within the past 2 years prior to first dose of tarlatamab with exceptions
  • Has evidence of interstitial lung disease or active, non-infectious pneumonitis
  • Part C only: history of solid organ transplantation or active autoimmune disease that has required systemic treatment within the past 2 years

Who the study is looking for

  • Participant has provided informed consent prior to initiation of any study-specific activities/procedures
  • Age greater than or equal to 18 years old at the time of signing the informed consent
  • Histologically or cytologically confirmed SCLC. For parts A, C, D, E, F, and G: relapsed/refractory small cell lung cancer (R/R SCLC) who progressed or recurred following platinum-based regimen
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Participants with treated brain metastases are eligible provided they meet defined criteria
  • Adequate organ function as defined in protocol

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (35)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Graz
Coordinator of this site? Confirm its status
GrazAustriaCompleted
Chris Obrien Lifehouse
Coordinator of this site? Confirm its status
CamperdownAustraliaUnknown status
Centre Hospitalier Universitaire Vaudois
Coordinator of this site? Confirm its status
LausanneSwitzerlandUnknown status
Kantonsspital St. Gallen
Coordinator of this site? Confirm its status
Sankt GallenSwitzerlandUnknown status
Universitaetsklinikum Wuerzburg AöR
Coordinator of this site? Confirm its status
WuerzburgGermanyActive, not recruiting
Hospital Clinic de Barcelona
Coordinator of this site? Confirm its status
BarcelonaSpainActive, not recruiting
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
Coordinator of this site? Confirm its status
MadridSpainActive, not recruiting
Institut Gustave Roussy
Coordinator of this site? Confirm its status
VillejuifFranceActive, not recruiting
Christie Hospital
Coordinator of this site? Confirm its status
ManchesterUnited KingdomUnknown status
Prince of Wales Hospital
Coordinator of this site? Confirm its status
Shatin, New TerritoriesHong Kong SAR ChinaUnknown status
National Cancer Center Hospital
Coordinator of this site? Confirm its status
Chuo KuJapanUnknown status
National Cancer Center Hospital East
Coordinator of this site? Confirm its status
Kashiwa-shiJapanUnknown status
Wakayama Medical University Hospital
Coordinator of this site? Confirm its status
WakayamaJapanUnknown status
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Coordinator of this site? Confirm its status
AmsterdamNetherlandsCompleted
Biokinetica S.A.
Coordinator of this site? Confirm its status
JozefowPolandActive, not recruiting
Europejskie Centrum Zdrowia Otwock Sp. Z.o.o.
Coordinator of this site? Confirm its status
OtwockPolandActive, not recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Coordinator of this site? Confirm its status
Kaohsiung CityTaiwanUnknown status
Tri-Service General Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Coordinator of this site? Confirm its status
TaoyuanTaiwanUnknown status
Winship Cancer Institute
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
John Hopkins Sidney Kimmel Comprehensive Cancer Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
University of Chicago
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
University Hospitals Cleveland Medical Center*
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status
Henry Ford Health System
Coordinator of this site? Confirm its status
DetroitUnited StatesUnknown status
City of Hope National Medical Center
Coordinator of this site? Confirm its status
DuarteUnited StatesUnknown status
Sarah Cannon Research Institute
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status
Yale New Haven Hospital
Coordinator of this site? Confirm its status
New HavenUnited StatesUnknown status
Ochsner Clinic Foundation
Coordinator of this site? Confirm its status
New OrleansUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Fox Chase Cancer Center
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
University of Pittsburgh Medical Center Cancer Pavillion
Coordinator of this site? Confirm its status
PittsburghUnited StatesUnknown status
Washington University
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
Moffitt Cancer Center
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.