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

June 25, 2026 updated by: Amgen

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)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Chris OBrien Lifehouse
      • Waratah, New South Wales, Australia, 2298
        • Recruiting
        • Calvary Mater Newcastle Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital
  • Belgium
      • Ghent, Belgium, 9000
        • Recruiting
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium, 3000
        • Recruiting
        • Universitair Ziekenhuis Leuven - Campus Gasthuisberg
      • Liège, Belgium, 4000
        • Recruiting
        • Centre Hospitalier Universitaire de Liege - Sart Tilman
  • China
    • Jilin
      • Changchun, Jilin, China, 130012
        • Recruiting
        • Jilin cancer hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200433
        • Recruiting
        • Shanghai Pulmonary Hospital
  • Germany
      • Regensburg, Germany, 93053
        • Recruiting
        • Universitaetsklinikum Regensburg
      • Würzburg, Germany, 97078
        • Recruiting
        • Universitaetsklinikum Wuerzburg
  • Japan
    • Okayama-ken
      • Okayama, Okayama-ken, Japan, 700-8558
        • Recruiting
        • Okayama University Hospital
    • Wakayama
      • Wakayama, Wakayama, Japan, 641-8510
        • Recruiting
        • Wakayama Medical University Hospital
  • Poland
      • Gdansk, Poland, 80-214
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne
      • Lodz, Poland, 93-338
        • Recruiting
        • Instytut Centrum Zdrowia Matki Polki
      • Przemyśl, Poland, 37-700
        • Recruiting
        • Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
  • Spain
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
    • Andalusia
      • Málaga, Andalusia, Spain, 29011
        • Recruiting
        • Hospital Regional Universitario de Málaga
    • Catalonia
      • Barcelona, Catalonia, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall D Hebron
    • Valencia
      • Valencia, Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe
  • Switzerland
      • Chur, Switzerland, 7000
        • Recruiting
        • Kantonsspital Graubuenden
      • Fribourg, Switzerland, 1708
        • Recruiting
        • Freiburg Spital
      • Winterthur, Switzerland, 8401
        • Recruiting
        • Kantonsspital Winterthur
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01370
        • Recruiting
        • Adana Sehir Egitim ve Arastirma Hastanesi
      • Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Ankara Bilkent Sehir Hastanesi
      • Istanbul, Turkey (Türkiye), 34010
        • Recruiting
        • Koc Universitesi Hastanesi
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California, Norris Comprehensive Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois Chicago
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Recruiting
        • Trinity Health Saint Joseph Mercy Ann Arbor
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Institute
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Swedish Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1 Dose Exploration
Tarlatamab will be administered as a SC injection in Part 1.
Drug: Tarlatamab
Administered by SC injection.
Other Names:
  • AMG 757
  • Imdelltra
Experimental: Part 2 Dose Expansion
Following the selection of a SC dosing regimen in Part 1, tarlatamab will be administered in Part 2 at the dose deemed safe and tolerable in Part 1.
Drug: Tarlatamab
Administered by SC injection.
Other Names:
  • AMG 757
  • Imdelltra
Experimental: Part 3 Alternative Dosing
Following the selection of a SC dosing regimen from Part 1 that will be used in Part 2 dose expansion, Part 3 may open to test alternative dosing of SC tarlatamab.
Drug: Tarlatamab
Administered by SC injection.
Other Names:
  • AMG 757
  • Imdelltra

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Participants with Dose-limiting toxicities (DLTs)
Time Frame: Up to day 21
Up to day 21
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to approximately 24 months
Up to approximately 24 months
Number of Participants with Changes in Vital Signs
Time Frame: Up to approximately 24 months
Up to approximately 24 months
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Time Frame: Up to approximately 24 months
Up to approximately 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 24 months
Up to approximately 24 months
Maximum Serum Concentration (Cmax) of Tarlatamab
Time Frame: Up to approximately 12 months
Up to approximately 12 months
Serum Concentration Prior to Dosing (Ctrough) of Tarlatamab
Time Frame: Up to approximately 12 months
Up to approximately 12 months
Time to Cmax (Tmax) of Tarlatamab
Time Frame: Up to approximately 12 months
Up to approximately 12 months
Area Under the Concentration-time Curve (AUC) of Tarlatamab
Time Frame: Up to approximately 12 months
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
Up to approximately 24 months
Duration of Response (DOR) per RECIST 1.1
Time Frame: Up to approximately 24 months
Up to approximately 24 months
Time to Response (TTR) per RECIST 1.1
Time Frame: Up to approximately 24 months
Up to approximately 24 months
Progression-free Survival (PFS) per RECIST 1.1
Time Frame: Up to approximately 24 months
Up to approximately 24 months
Time to Progression per RECIST 1.1
Time Frame: Up to approximately 24 months
Up to approximately 24 months
Time to Subsequent Therapy
Time Frame: Up to approximately 24 months
Up to approximately 24 months
Number of Participants with Anti-tarlatamab Antibody Formation
Time Frame: Up to approximately 24 months
Up to approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
BeOne Medicines

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 24, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 24, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20230298 (Swedish Heart Lung Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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