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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06598306




Registration number
NCT06598306
Ethics application status
Date submitted
13/09/2024
Date registered
19/09/2024

Titles & IDs
Public title
Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
Scientific 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)
Secondary ID [1] 0 0
20230298
Universal Trial Number (UTN)
Trial acronym
DeLLphi-308
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extensive Stage Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tarlatamab

Experimental: Part 1 Dose Exploration - Tarlatamab will be administered as a SC injection in Part 1.

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.


Treatment: Drugs: Tarlatamab
Administered by SC injection.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Dose-limiting toxicities (DLTs)
Timepoint [1] 0 0
Up to day 21
Primary outcome [2] 0 0
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
Up to approximately 24 months
Primary outcome [3] 0 0
Number of Participants with Changes in Vital Signs
Timepoint [3] 0 0
Up to approximately 24 months
Primary outcome [4] 0 0
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Timepoint [4] 0 0
Up to approximately 24 months
Secondary outcome [1] 0 0
Maximum Serum Concentration (Cmax) of Tarlatamab
Timepoint [1] 0 0
Up to approximately 12 months
Secondary outcome [2] 0 0
Serum Concentration Prior to Dosing (Ctrough) of Tarlatamab
Timepoint [2] 0 0
Up to approximately 12 months
Secondary outcome [3] 0 0
Time to Cmax (Tmax) of Tarlatamab
Timepoint [3] 0 0
Up to approximately 12 months
Secondary outcome [4] 0 0
Area Under the Concentration-time Curve (AUC) of Tarlatamab
Timepoint [4] 0 0
Up to approximately 12 months
Secondary outcome [5] 0 0
Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Timepoint [5] 0 0
Up to approximately 24 months
Secondary outcome [6] 0 0
Duration of Response (DOR) per RECIST 1.1
Timepoint [6] 0 0
Up to approximately 24 months
Secondary outcome [7] 0 0
Time to Response (TTR) per RECIST 1.1
Timepoint [7] 0 0
Up to approximately 24 months
Secondary outcome [8] 0 0
Progression-free Survival (PFS) per RECIST 1.1
Timepoint [8] 0 0
Up to approximately 24 months
Secondary outcome [9] 0 0
Time to Progression per RECIST 1.1
Timepoint [9] 0 0
Up to approximately 24 months
Secondary outcome [10] 0 0
Time to Subsequent Therapy
Timepoint [10] 0 0
Up to approximately 24 months
Secondary outcome [11] 0 0
Overall Survival (OS)
Timepoint [11] 0 0
Up to approximately 24 months
Secondary outcome [12] 0 0
Number of Participants with Anti-tarlatamab Antibody Formation
Timepoint [12] 0 0
Up to approximately 24 months

Eligibility
Key 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 regimen.
* 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 (and/or thigh).
* Participants without measurable disease or tumor tissue (fresh biopsy or archival) available may be permitted after discussion with and approval by Amgen Medical Monitor.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2028
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Calvary Mater Newcastle Hospital - Waratah
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
South Dakota

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
medinfo@amgen.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06598306