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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06211036




Registration number
NCT06211036
Ethics application status
Date submitted
8/01/2024
Date registered
18/01/2024

Titles & IDs
Public title
Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
Scientific title
A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination With Durvalumab vs Durvalumab Alone in Subjects With Extensive-Stage Small-Cell Lung Cancer Following Platinum, Etoposide and Durvalumab (DeLLphi-305)
Secondary ID [1] 0 0
2023-505989-29
Secondary ID [2] 0 0
20200041
Universal Trial Number (UTN)
Trial acronym
DeLLphi-305
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extensive-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 - Durvalumab

Experimental: Tarlatamab in Combination With Durvalumab - Participants will receive tarlatamab once every 2 weeks (Q2W) and durvalumab once every 4 weeks (Q4W).

Active comparator: Durvalumab Alone - Participants will receive durvalumab Q4W alone.


Treatment: Drugs: Tarlatamab
Intravenous (IV) infusion

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

Outcomes
Primary outcome [1] 0 0
OS
Timepoint [1] 0 0
Up to approximately 3 years
Secondary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Up to approximately 3 years
Secondary outcome [2] 0 0
Overall Response (OR)
Timepoint [2] 0 0
Up to approximately 3 years
Secondary outcome [3] 0 0
Disease Control (DC) Rate
Timepoint [3] 0 0
Up to approximately 3 years
Secondary outcome [4] 0 0
Duration of Response (DoR)
Timepoint [4] 0 0
Up to approximately 3 years
Secondary outcome [5] 0 0
PFS at 6 Months
Timepoint [5] 0 0
6 months
Secondary outcome [6] 0 0
PFS at 1 Year
Timepoint [6] 0 0
1 year
Secondary outcome [7] 0 0
PFS at 2 Years
Timepoint [7] 0 0
2 years
Secondary outcome [8] 0 0
OS at 6 Months
Timepoint [8] 0 0
6 months
Secondary outcome [9] 0 0
OS at 1 Year
Timepoint [9] 0 0
1 year
Secondary outcome [10] 0 0
OS at 2 Years
Timepoint [10] 0 0
2 years
Secondary outcome [11] 0 0
OS at 3 Years
Timepoint [11] 0 0
3 years
Secondary outcome [12] 0 0
Time to Progression (TTP)
Timepoint [12] 0 0
Up to approximately 3 years
Secondary outcome [13] 0 0
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timepoint [13] 0 0
Up to approximately 9 months
Secondary outcome [14] 0 0
Number of Participants with TEAEs Grade 3 or Above per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Timepoint [14] 0 0
Up to approximately 3 years
Secondary outcome [15] 0 0
Number of Participants with Serious TEAEs
Timepoint [15] 0 0
Up to approximately 3 years
Secondary outcome [16] 0 0
Number of Participants with TEAEs Leading to Discontinuation of Treatment
Timepoint [16] 0 0
Up to approximately 3 years
Secondary outcome [17] 0 0
Number of Participants with Fatal TEAEs
Timepoint [17] 0 0
Up to approximately 3 years
Secondary outcome [18] 0 0
Number of Participants with Treatment-related Adverse Events (AEs)
Timepoint [18] 0 0
Up to approximately 9 months
Secondary outcome [19] 0 0
Number of Participants with Adverse Events of Interest (EOI)
Timepoint [19] 0 0
Up to approximately 9 months
Secondary outcome [20] 0 0
Serum Concentrations of Tarlatamab
Timepoint [20] 0 0
Day 1 up to approximately 6 months
Secondary outcome [21] 0 0
Number of Participants with Antitarlatamab Antibody Formation
Timepoint [21] 0 0
Up to approximately 9 months
Secondary outcome [22] 0 0
Time to First Deterioration (TTD) for Physical Function as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC-QLQ-C30)
Timepoint [22] 0 0
Up to approximately 9 months
Secondary outcome [23] 0 0
Change in Disease Symptoms of Cough as Measured Using EORTC-QLQ LC13
Timepoint [23] 0 0
Up to 12 months
Secondary outcome [24] 0 0
Change in Disease Symptoms of Chest Pain as Measured Using EORTC-QLQ LC13
Timepoint [24] 0 0
Up to 12 months
Secondary outcome [25] 0 0
Change in Disease Symptoms of Dyspnea as Measured Using EORTC-QLQ LC13
Timepoint [25] 0 0
Up to 12 months
Secondary outcome [26] 0 0
TTD for Global Health Status as Measured by EORTC-QLQ-C30
Timepoint [26] 0 0
Up to approximately 9 months
Secondary outcome [27] 0 0
TTD for Quality of Life as Measured by EORTC-QLQ-C30
Timepoint [27] 0 0
Up to approximately 9 months

Eligibility
Key inclusion criteria
Inclusion:

* Participant has provided informed consent prior to initiation of any study specific activities/procedures.
* Age >= 18 years (or >= legal adult age within the country if it is older than 18 years).
* Completed 3-4 cycles of platinum-etoposide chemotherapy with concurrent durvalumab as first-line treatment of extensive-stage (ES)-SCLC prior to enrollment, without disease progression (ongoing response or stable disease) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
* Minimum life expectancy > 12 weeks.
* Toxicities attributed to prior anti-cancer therapy resolved to grade = 1, unless otherwise specified, excluding alopecia or fatigue.
* Adequate organ function.
* Histologically or cytologically documented extensive-stage disease (American Joint Committee on Cancer, 2017, IV small-cell lung cancer (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.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion

* Symptomatic central nervous system (CNS) metastases, or leptomeningeal disease. Participants with treated brain metastases are eligible as per protocol.
* Prior history of severe or life-threatening events from any immune-mediated therapy.
* History of other malignancy within the past 2 years, with some exceptions as per protocol.
* Active or prior documented autoimmune or inflammatory disorders as per protocol.
* Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months of first dose of study treatment.
* History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months of first dose of study treatment.
* Evidence of interstitial lung disease (ILD) or active, non-infectious pneumonitis.
* History of solid organ transplant.
* Major surgical procedures within 28 days of first dose of study treatment.
* Known human immunodeficiency virus (HIV) infection (participants with HIV infection on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on study), hepatitis C infection (participants with hepatitis C that achieve a sustained virologic response after antiviral therapy are allowed), or hepatitis B infection (participants with hepatitis B surface antigen [HBsAg] or core antibody that achieve sustained virologic response with antiviral therapy are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on the study).
* Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment.
* History of allergic reactions or acute hypersensitivity reaction to antibody therapies, platinum chemotherapy, or etoposide.
* 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.
* Participant has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint.
* Treatment with live virus, including live-attenuated vaccination, within 4 weeks prior to the first dose of study treatment. Inactive vaccines (e.g., non-live or non-replicating agent) and live viral non-replicating vaccines (e.g., Jynneos for Monkeypox infection) within 30 days prior to first dose of study treatment.
* Prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.
* Receiving another anti-cancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted.
* Treatment in an alternative investigational trial within 28 days prior to enrollment.
* Has received or is planning to receive consolidative chest radiation for extensive stage disease.
* Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment as per protocol.
* Female participants who are breastfeeding or who plan to breastfeed while on study as per protocol.
* Female participants planning to become pregnant or donate eggs while on study as per protocol.
* 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 as per protocol.
* Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment as per protocol.
* Male participants unwilling to abstain from donating sperm during treatment as per protocol.
* Participant has known sensitivity to any of the products or components to be administered during dosing.
* Participant has known sensitivity to any of the products or components to be administered during dosing.
* History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or physician if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
* Participant likely not to be available to complete all protocol-required study visits or procedures to the best of the participant and investigator's knowledge.

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
5/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/09/2028
Actual
Sample size
Target
550
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [2] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
4120 - Greenslopes
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
Brazil
State/province [13] 0 0
Minas Gerais
Country [14] 0 0
Brazil
State/province [14] 0 0
São Paulo
Country [15] 0 0
China
State/province [15] 0 0
Beijing
Country [16] 0 0
China
State/province [16] 0 0
Chongqing
Country [17] 0 0
China
State/province [17] 0 0
Fujian
Country [18] 0 0
China
State/province [18] 0 0
Guangdong
Country [19] 0 0
China
State/province [19] 0 0
Guangxi
Country [20] 0 0
China
State/province [20] 0 0
Heilongjiang
Country [21] 0 0
China
State/province [21] 0 0
Henan
Country [22] 0 0
China
State/province [22] 0 0
Hubei
Country [23] 0 0
China
State/province [23] 0 0
Jiangsu
Country [24] 0 0
China
State/province [24] 0 0
Jiangxi
Country [25] 0 0
China
State/province [25] 0 0
Jilin
Country [26] 0 0
China
State/province [26] 0 0
Shandong
Country [27] 0 0
China
State/province [27] 0 0
Shanghai
Country [28] 0 0
China
State/province [28] 0 0
Sichuan
Country [29] 0 0
China
State/province [29] 0 0
Xinjiang
Country [30] 0 0
China
State/province [30] 0 0
Zhejiang
Country [31] 0 0
Japan
State/province [31] 0 0
Chiba
Country [32] 0 0
Japan
State/province [32] 0 0
Ehime
Country [33] 0 0
Japan
State/province [33] 0 0
Fukuoka
Country [34] 0 0
Japan
State/province [34] 0 0
Hokkaido
Country [35] 0 0
Japan
State/province [35] 0 0
Hyogo
Country [36] 0 0
Japan
State/province [36] 0 0
Kanagawa
Country [37] 0 0
Japan
State/province [37] 0 0
Niigata
Country [38] 0 0
Japan
State/province [38] 0 0
Okayama
Country [39] 0 0
Japan
State/province [39] 0 0
Osaka
Country [40] 0 0
Japan
State/province [40] 0 0
Saitama
Country [41] 0 0
Japan
State/province [41] 0 0
Shizuoka
Country [42] 0 0
Japan
State/province [42] 0 0
Tokyo
Country [43] 0 0
Japan
State/province [43] 0 0
Wakayama
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Goyang-si Gyeonggi-do
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Seongnam-si, Gyeonggi-do
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Seoul
Country [47] 0 0
Switzerland
State/province [47] 0 0
Basel
Country [48] 0 0
Switzerland
State/province [48] 0 0
Mendrisio
Country [49] 0 0
Switzerland
State/province [49] 0 0
Sankt Gallen
Country [50] 0 0
Taiwan
State/province [50] 0 0
Tainan
Country [51] 0 0
Taiwan
State/province [51] 0 0
Taipei
Country [52] 0 0
Turkey
State/province [52] 0 0
Ankara
Country [53] 0 0
Turkey
State/province [53] 0 0
Istanbul
Country [54] 0 0
Turkey
State/province [54] 0 0
Izmir
Country [55] 0 0
Turkey
State/province [55] 0 0
Mersin
Country [56] 0 0
Turkey
State/province [56] 0 0
Sakarya

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: https://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/NCT06211036