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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06745323




Registration number
NCT06745323
Ethics application status
Date submitted
17/12/2024
Date registered
20/12/2024

Titles & IDs
Public title
A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With SCLC
Scientific title
A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With Small Cell Lung Cancer (SCLC) (DeLLphi-309)
Secondary ID [1] 0 0
20240092
Universal Trial Number (UTN)
Trial acronym
DeLLphi-309
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Small Cell Lung Cancer (SCLC) 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(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Tarlatamab

Experimental: Treatment Arm A: Dose 1 Tarlatamab - Participants will receive dose 1 of Tarlatamab by intravenous (IV) infusion during the treatment period.

Experimental: Treatment Arm B: Dose 2 Tarlatamab - Participants will receive dose 2 of Tarlatamab by IV infusion during the treatment period.

Experimental: Treatment Arm C: Dose 3 Tarlatamab - Participants will receive dose 3 of Tarlatamab by IV infusion during the treatment period.


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

Outcomes
Primary outcome [1] 0 0
Proportion of participants with confirmed objective response to Tarlatamab
Timepoint [1] 0 0
Approximately 52 Months
Primary outcome [2] 0 0
Proportion of participants with complete response to Tarlatamab
Timepoint [2] 0 0
Approximately 52 Months
Primary outcome [3] 0 0
Proportion of participants with partial response to Tarlatamab
Timepoint [3] 0 0
Approximately 52 Months
Secondary outcome [1] 0 0
Average serum concentrations of Tarlatamab
Timepoint [1] 0 0
Approximately 52 Weeks
Secondary outcome [2] 0 0
Duration of confirmed response, defined as the time from the first documentation of OR until the first documentation of disease progression or death
Timepoint [2] 0 0
Approximately 52 Months
Secondary outcome [3] 0 0
Disease control, defined as objective response or stable disease
Timepoint [3] 0 0
Approximately 52 Months
Secondary outcome [4] 0 0
Duration of disease control
Timepoint [4] 0 0
Approximately 52 Months
Secondary outcome [5] 0 0
Progression-free survival, defined as the time from randomization to the first documentation of disease progression or death due to any cause
Timepoint [5] 0 0
Approximately 52 Months
Secondary outcome [6] 0 0
Objective response, defined as best overall response of CR or PR
Timepoint [6] 0 0
Approximately 52 Months
Secondary outcome [7] 0 0
Overall survival, defined as the time from randomization to death due to any cause
Timepoint [7] 0 0
Approximately 52 Months
Secondary outcome [8] 0 0
Overall Survival rate at 6 months and 1 year from randomization
Timepoint [8] 0 0
Approximately 52 Months
Secondary outcome [9] 0 0
Number of participants with treatment-emergent adverse events
Timepoint [9] 0 0
Approximately 52 Months
Secondary outcome [10] 0 0
Number of participants with anti-tarlatamab antibody formation
Timepoint [10] 0 0
Approximately 52 Months

Eligibility
Key inclusion criteria
* Participant has provided informed consent prior to initiation of any study specific activities/procedures.
* Age = 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.
* Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.
* Participants who progressed or recurred following 1 platinum-based regimen.
* Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
* Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
* Minimum life expectancy of 12 weeks.
* Adequate organ function as described per protocol.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Disease Related

* Previous diagnosis of transformed non-small cell lung cancer (NSCLC) including epidermal growth factor receptor activating mutation positive NSCLC that has transformed to SCLC.
* Symptomatic central nervous system (CNS) metastases with exceptions defined in the protocol.
* Other Medical Conditions

* History of other malignancy within the past 2 years, with exceptions defined in the protocol.
* Evidence of interstitial lung disease or active, non-infectious pneumonitis
* Diagnosis or evidence of leptomeningeal disease.
* Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study.
* History of solid organ transplantation.
* Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months prior to first dose of study treatment.
* History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment
* Presence or history of viral infection based on criteria per protocol.
* Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment.
* Known or active infection requiring parenteral antibiotic treatment.
* History of severe or life-threatening events from any immune-mediated therapy.
* Major surgical procedures within 21 days of prior to first dose of study treatment.
* Prior/Concomitant Therapy

* Prior anticancer therapy within 30 days of enrollment (14 days for conventional chemotherapy).
* Prior enrollment on a tarlatamab clinical trial OR prior therapy with any selective inhibitor of the DLL3 pathway.
* Current anti-cancer therapy such as chemotherapy, immunotherapy, or targeted therapy with exceptions.
* Receiving systemic corticosteroid therapy or any other immunosuppressive therapy within 7 days prior to first dose as described per protocol.
* Live and live-attenuated vaccines within 14 days prior to the start of study treatment. Inactive vaccines and live viral non-replicating vaccines within 3 days prior to the first dose of study treatment.
* Prior/Concurrent Clinical Study Experience

* Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
* Other Exclusions

* Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 60 days after the last dose of tarlatamab.
* Female participants who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab.
* Female participants planning to become pregnant or donate eggs while on study through 60 days after the last dose of tarlatamab.
* Female participants of childbearing potential with a positive pregnancy test assessed at screening and/or day 1 by a highly sensitive urine or serum pregnancy test.
* Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 60 days after the last dose of tarlatamab.
* Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of tarlatamab.
* Male participants unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of tarlatamab.
* Participant has known sensitivity or is contraindicated to any of the products or components to be administered during dosing.
* Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures.
* History or evidence of any other clinically significant disorder, condition or disease determined by the investigator or Amgen physician, if consulted, would pose a risk to the subject safety or interfere with the study evaluation procedure or completion.

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 2
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
26/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/05/2029
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
China
State/province [4] 0 0
Beijing
Country [5] 0 0
China
State/province [5] 0 0
Fujian
Country [6] 0 0
China
State/province [6] 0 0
Hunan
Country [7] 0 0
China
State/province [7] 0 0
Tianjin
Country [8] 0 0
China
State/province [8] 0 0
Zhejiang
Country [9] 0 0
Japan
State/province [9] 0 0
Fukuoka
Country [10] 0 0
Japan
State/province [10] 0 0
Hokkaido
Country [11] 0 0
Japan
State/province [11] 0 0
Tokyo
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Cheongju Chungbuk
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Daegu
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Hwasun-gun, Jeollanam-do
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seongnam-si, Gyeonggi-do
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Seoul
Country [17] 0 0
Switzerland
State/province [17] 0 0
Baden
Country [18] 0 0
Switzerland
State/province [18] 0 0
Zuerich
Country [19] 0 0
Turkey
State/province [19] 0 0
Ankara

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
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT06745323