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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06117774




Registration number
NCT06117774
Ethics application status
Date submitted
31/10/2023
Date registered
7/11/2023

Titles & IDs
Public title
Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)
Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Tarlatamab Therapy in Subjects With Limited-Stage Small-Cell Lung Cancer (LS-SCLC) Who Have Not Progressed Following Concurrent Chemoradiation Therapy
Secondary ID [1] 0 0
2023-506235-15
Secondary ID [2] 0 0
20230016
Universal Trial Number (UTN)
Trial acronym
DeLLphi-306
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Limited Stage Small Cell Lung Cancer 0 0
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
Treatment: Drugs - Placebo

Experimental: Tarlatamab - Participants will receive tarlatamab on Cycle 1 Day 1, 8 and 15, and once every 2 weeks (Q2W) thereafter (cycle is 28 days).

Placebo comparator: Placebo - Participants will receive placebo on Cycle 1 Day 1, 8 and 15, and Q2W thereafter (cycle is 28 days).


Treatment: Drugs: Tarlatamab
Intravenous (IV) infusion

Treatment: Drugs: Placebo
IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PFS as Determined by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
Up to approximately 6 years
Secondary outcome [1] 0 0
Overall Survival (OS) Over the Whole Trial
Timepoint [1] 0 0
Up to approximately 6 years
Secondary outcome [2] 0 0
PFS Determined by Investigator Assessment
Timepoint [2] 0 0
Up to approximately 6 years
Secondary outcome [3] 0 0
Objective Response (OR) Rate
Timepoint [3] 0 0
Up to approximately 6 years
Secondary outcome [4] 0 0
Disease Control (DC) Rate
Timepoint [4] 0 0
Up to approximately 6 years
Secondary outcome [5] 0 0
Duration of Response (DOR)
Timepoint [5] 0 0
Up to approximately 6 years
Secondary outcome [6] 0 0
PFS at 6 months, 1 year, 2 years
Timepoint [6] 0 0
6 months, 1 year, 2 years
Secondary outcome [7] 0 0
OS at 6 months, 1 year, 2 years, 3 years
Timepoint [7] 0 0
6 months, 1 year, 2 years, 3 years
Secondary outcome [8] 0 0
Time to Progression (TTP)
Timepoint [8] 0 0
Up to approximately 6 years
Secondary outcome [9] 0 0
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timepoint [9] 0 0
Up to approximately 6 years
Secondary outcome [10] 0 0
Serum Concentration of Tarlatamab
Timepoint [10] 0 0
Up to approximately 4 months
Secondary outcome [11] 0 0
Incidence of Anti-tarlatamab Antibody Formation
Timepoint [11] 0 0
Up to approximately 1 year

Eligibility
Key inclusion criteria
-Participants are eligible to be included in the study only if all of the following criteria apply:

* Participant has provided informed consent prior to 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 confirmed small-cell lung cancer (SCLC).
* Diagnosed and treated for LS-SCLC with concurrent chemotherapy and radiotherapy.
* Has completed chemoradiotherapy without progression per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1.) (ie, achieved complete response [CR], partial response [PR], or stable disease [SD]).
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
* Minimum life expectancy of 12 weeks.
* Adequate organ function.
* Toxicities attributed to concurrent chemoradiotherapy resolved to grade = 1, unless otherwise specified. Excluding alopecia or fatigue.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Participants are excluded from the study if any of the following criteria apply:

Disease Related

* Extensive-stage SCLC (ES-SCLC).
* Any previous diagnosis of transformed non-small-cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology.
* Evidence of interstitial lung disease or active, non-infectious pneumonitis. Other Medical Conditions
* History of other malignancy within the past 2 years, with certain exceptions.
* 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.
* Exclusion of human immunodeficiency virus (HIV) and/or hepatitis infection based on criteria per protocol.
* 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 study treatment.

Prior/Concomitant Therapy

* Received sequential chemotherapy and thoracic radiotherapy (no overlap of thoracic radiotherapy with chemotherapy) during chemoradiation.
* Prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.
* Prior history of severe or life-threatening events from any immune-mediated therapy.
* Receiving another anti-cancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted.
* Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment.
* Major surgical procedures within 28 days prior to first dose of study treatment.
* Treatment with live virus, including live-attenuated vaccination, within 14 days prior to the first dose of study treatment. Inactive vaccines and live viral non-replicating vaccines within 3 days prior to first dose of study treatment.

Prior/Concurrent Clinical Study Experience

• Treatment in an alternative investigational trial within 28 days prior to enrollment.

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 study treatment.
* Female participants who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of study treatment.
* Female participants planning to become pregnant or donate eggs while on study through 60 days after the last dose of study treatment.
* Female participants of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive 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 study treatment.
* 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 study treatment.
* Male participants unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of study treatment.
* Participant has known sensitivity 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 to the best of the participant and investigator's knowledge.
* History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
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
20/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2029
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [4] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [5] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Louisiana
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Virginia
Country [6] 0 0
United States of America
State/province [6] 0 0
West Virginia
Country [7] 0 0
Argentina
State/province [7] 0 0
Buenos Aires
Country [8] 0 0
China
State/province [8] 0 0
Beijing
Country [9] 0 0
China
State/province [9] 0 0
Fujian
Country [10] 0 0
China
State/province [10] 0 0
Guangdong
Country [11] 0 0
China
State/province [11] 0 0
Hubei
Country [12] 0 0
China
State/province [12] 0 0
Hunan
Country [13] 0 0
China
State/province [13] 0 0
Jiangsu
Country [14] 0 0
China
State/province [14] 0 0
Jiangxi
Country [15] 0 0
China
State/province [15] 0 0
Jilin
Country [16] 0 0
China
State/province [16] 0 0
Shandong
Country [17] 0 0
China
State/province [17] 0 0
Shanxi
Country [18] 0 0
China
State/province [18] 0 0
Tianjin
Country [19] 0 0
China
State/province [19] 0 0
Xinjiang
Country [20] 0 0
China
State/province [20] 0 0
Zhejiang
Country [21] 0 0
China
State/province [21] 0 0
Chongqing
Country [22] 0 0
Hong Kong
State/province [22] 0 0
Shatin, New Territories
Country [23] 0 0
Japan
State/province [23] 0 0
Aichi
Country [24] 0 0
Japan
State/province [24] 0 0
Chiba
Country [25] 0 0
Japan
State/province [25] 0 0
Ehime
Country [26] 0 0
Japan
State/province [26] 0 0
Fukuoka
Country [27] 0 0
Japan
State/province [27] 0 0
Hokkaido
Country [28] 0 0
Japan
State/province [28] 0 0
Kanagawa
Country [29] 0 0
Japan
State/province [29] 0 0
Miyagi
Country [30] 0 0
Japan
State/province [30] 0 0
Niigata
Country [31] 0 0
Japan
State/province [31] 0 0
Okayama
Country [32] 0 0
Japan
State/province [32] 0 0
Osaka
Country [33] 0 0
Japan
State/province [33] 0 0
Saitama
Country [34] 0 0
Japan
State/province [34] 0 0
Shizuoka
Country [35] 0 0
Japan
State/province [35] 0 0
Tochigi
Country [36] 0 0
Japan
State/province [36] 0 0
Tokyo
Country [37] 0 0
Japan
State/province [37] 0 0
Wakayama
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Cheongju Chungbuk
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Incheon
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Seongnam-si, Gyeonggi-do
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Seoul
Country [42] 0 0
Singapore
State/province [42] 0 0
Singapore
Country [43] 0 0
Taiwan
State/province [43] 0 0
Kaohsiung
Country [44] 0 0
Taiwan
State/province [44] 0 0
Taipei
Country [45] 0 0
Turkey
State/province [45] 0 0
Ankara
Country [46] 0 0
Turkey
State/province [46] 0 0
Istanbul
Country [47] 0 0
Turkey
State/province [47] 0 0
Izmir
Country [48] 0 0
Turkey
State/province [48] 0 0
Kocaeli
Country [49] 0 0
Turkey
State/province [49] 0 0
Mersin

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
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/NCT06117774