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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07005128




Registration number
NCT07005128
Ethics application status
Date submitted
27/05/2025
Date registered
5/06/2025
Date last updated
11/09/2025

Titles & IDs
Public title
A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)
Scientific 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)
Secondary ID [1] 0 0
20240178
Universal Trial Number (UTN)
Trial acronym
DeLLphi-312
Linked study record

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

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

Experimental: Tarlatamab + Durvalumab + Carboplatin + Etoposide - Participants will receive tarlatamab in combination with durvalumab, carboplatin and etoposide for 4 cycles followed by tarlatamab and durvalumab.

Active comparator: Durvalumab + Carboplatin + Etoposide - Participants will receive durvalumab, carboplatin and etoposide for 4 cycles followed by durvalumab.


Treatment: Drugs: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.

Treatment: Drugs: Durvalumab
Durvalumab will be administered as an IV infusion.

Treatment: Drugs: Carboplatin
Carboplatin will be administered as an IV infusion.

Treatment: Drugs: Etoposide
Etoposide will be administered as an IV infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 3.5 years
Secondary outcome [1] 0 0
Progression free survival (PFS)
Timepoint [1] 0 0
Up to approximately 4 years
Secondary outcome [2] 0 0
Objective Response (OR)
Timepoint [2] 0 0
Up to approximately 4 years
Secondary outcome [3] 0 0
Disease Control
Timepoint [3] 0 0
Up to approximately 4 years
Secondary outcome [4] 0 0
Duration of Response (DOR)
Timepoint [4] 0 0
Up to approximately 4 years
Secondary outcome [5] 0 0
PFS Rate
Timepoint [5] 0 0
6 months, 1 year, and 2 years
Secondary outcome [6] 0 0
OS Rate
Timepoint [6] 0 0
6 months, 1 year, and 2 years
Secondary outcome [7] 0 0
Time to Progression
Timepoint [7] 0 0
Up to approximately 4 years
Secondary outcome [8] 0 0
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)
Timepoint [8] 0 0
Up to approximately 4 years
Secondary outcome [9] 0 0
Number of Participants Who Experience Treatment-related Adverse Events
Timepoint [9] 0 0
Up to approximately 4 years
Secondary outcome [10] 0 0
Number of Participants Who Experience Events of Interest
Timepoint [10] 0 0
Up to approximately 4 years
Secondary outcome [11] 0 0
Serum Concentrations of Tarlatamab
Timepoint [11] 0 0
Up to approximately 1 year
Secondary outcome [12] 0 0
Number of Participant Who Develop Anti-Tarlatamab Antibodies
Timepoint [12] 0 0
Up to 13 months

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/08/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/07/2029
Actual
Sample size
Target
330
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Chris OBrien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Tennessee
Country [2] 0 0
China
State/province [2] 0 0
Shanghai Municipality
Country [3] 0 0
China
State/province [3] 0 0
Beijing
Country [4] 0 0
China
State/province [4] 0 0
Fuzhou
Country [5] 0 0
Hong Kong
State/province [5] 0 0
Hong Kong
Country [6] 0 0
Hong Kong
State/province [6] 0 0
Shatin, New Territories
Country [7] 0 0
Japan
State/province [7] 0 0
Fukuoka
Country [8] 0 0
Japan
State/province [8] 0 0
Hyogo
Country [9] 0 0
Japan
State/province [9] 0 0
Wakayama
Country [10] 0 0
South Korea
State/province [10] 0 0
Cheongju Chungbuk
Country [11] 0 0
South Korea
State/province [11] 0 0
Seoul
Country [12] 0 0
Switzerland
State/province [12] 0 0
Geneva
Country [13] 0 0
Taiwan
State/province [13] 0 0
Taipei
Country [14] 0 0
Turkey (Türkiye)
State/province [14] 0 0
Ankara
Country [15] 0 0
Turkey (Türkiye)
State/province [15] 0 0
Istanbul
Country [16] 0 0
Turkey (Türkiye)
State/province [16] 0 0
Sakarya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AstraZeneca
Address [1] 0 0
Country [1] 0 0

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
[email protected]
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/NCT07005128