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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05740566




Registration number
NCT05740566
Ethics application status
Date submitted
7/02/2023
Date registered
23/02/2023
Date last updated
28/08/2024

Titles & IDs
Public title
Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer
Scientific title
A Randomized, Open-label, Phase 3 Study of Tarlatamab Compared With Standard of Care in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy
Secondary ID [1] 0 0
20210004
Universal Trial Number (UTN)
Trial acronym
DeLLphi-304
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
Treatment: Drugs - Lurbinectedin
Treatment: Drugs - Topotecan
Treatment: Drugs - Amrubicin

Experimental: Tarlatamab - Participants will receive tarlatamab as an intravenous (IV) infusion.

Active comparator: Standard of Care - Participants will receive treatment per local standard of care (SOC).


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

Treatment: Drugs: Lurbinectedin
Lurbinectedin will be administered per local SOC.

Treatment: Drugs: Topotecan
Topotecan will be administered per local SOC.

Treatment: Drugs: Amrubicin
Amrubicin will be administered per local SOC.
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 4 years
Secondary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Up to approximately 4 years
Secondary outcome [2] 0 0
Change from Baseline In Selected Functional Scales and Disease Symptom Items Included in Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Timepoint [2] 0 0
Up to approximately 4 years
Secondary outcome [3] 0 0
Change from Baseline in Selected Disease Symptoms Included in Lung Cancer Quality of Life Questionnaire (EORTC-QLQ-LC13)
Timepoint [3] 0 0
Up to approximately 4 years
Secondary outcome [4] 0 0
Overall Response (OR)
Timepoint [4] 0 0
Up to approximately 4 years
Secondary outcome [5] 0 0
Disease Control (DC)
Timepoint [5] 0 0
Up to approximately 4 years
Secondary outcome [6] 0 0
Duration of Response (DOR)
Timepoint [6] 0 0
Up to approximately 4 years
Secondary outcome [7] 0 0
PFS
Timepoint [7] 0 0
1 year
Secondary outcome [8] 0 0
OS
Timepoint [8] 0 0
1 year, 2 years and 3 years
Secondary outcome [9] 0 0
Incidence of Treatment-Emergent Adverse Events (TEAE)
Timepoint [9] 0 0
Up to approximately 4 years
Secondary outcome [10] 0 0
Serum Concentrations of Tarlatamab
Timepoint [10] 0 0
Up to 1 year
Secondary outcome [11] 0 0
Number of Participants Who Experience Anti-tarlatamab Antibodies
Timepoint [11] 0 0
Up to 1 year
Secondary outcome [12] 0 0
Change from Baseline in Pain Severity as Measured by Brief Pain Inventory - Short Form (BPI-SF)
Timepoint [12] 0 0
Up to approximately 4 years
Secondary outcome [13] 0 0
Patient Perceived Health at Each Assessment Visit Using Visual Analogue Scale (VAS)
Timepoint [13] 0 0
Up to approximately 4 years
Secondary outcome [14] 0 0
Change from Baseline in Patient Perceived Health Using Visual Analog Scale (VAS)
Timepoint [14] 0 0
Up to approximately 4 years
Secondary outcome [15] 0 0
Responses to Patient-Reported Adverse Events Questionnaire (PRO-CTCAE)
Timepoint [15] 0 0
Up to approximately 4 years
Secondary outcome [16] 0 0
Change from Baseline in Symptom Severity as Measured by Patient Global Impression of Severity (PGIS) Questionnaire
Timepoint [16] 0 0
Up to approximately 4 years
Secondary outcome [17] 0 0
Change from Baseline in Symptoms and Overall Status as Measured by Patient Reported Impression of Change (PGIC) Questionnaire
Timepoint [17] 0 0
Up to approximately 4 years
Secondary outcome [18] 0 0
Change from Baseline in Symptom Bother as Measured by Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire
Timepoint [18] 0 0
Up to approximately 4 years

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Disease Related

* Symptomatic central nervous system (CNS) metastases with exceptions defined in the protocol.
* Diagnosis or evidence of leptomeningeal disease.
* Prior history of immune checkpoint inhibitors resulting in events defined in the protocol.
* Other Medical Conditions

* Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy.
* History of solid organ transplantation.
* History of other malignancy within the past 2 years, with exceptions defined in the protocol.
* Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months prior to first dose of study treatment.
* History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months prior to first dose of study treatment.
* Presence or history of viral infection based on criteria per protocol.
* Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of study treatment.
* 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.
* Evidence of interstitial lung disease or active, non-infectious pneumonitis.
* Prior/Concomitant Therapy

* Prior therapy with tarlatamab or any of the standard of care chemotherapy included as part of this trial or participation in any tarlatamab or any other DLL3 targeted agent clinical trial.
* Prior therapy with any selective inhibitor of the DLL3 pathway.
* Participant received more than one prior systemic therapy regimen for SCLC.
* Prior anti-cancer therapy within 21 days prior to first dose of study treatment with exceptions defined in protocol.
* Current anti-cancer therapy such as chemotherapy, immunotherapy, or targeted therapy with exceptions.
* Use of herbal or prescription/non-prescription medications known to inhibit membrane transporters P-glycoprotein (P-gp) and/or breast cancer resistance protein (BCRP) within 7 days prior to the first dose of study treatment.
* Use of herbal or prescription/non-prescription medications known to be moderate or strong inhibitors of cytochrome P450 3A (CYP3A) enzymes within 7 days prior to the first dose of study treatment.
* Use of herbal or prescription/non-prescription medications known to be moderate or strong inducers of CYP3A enzymes within 28 days prior to first dose of study treatment.
* Participants who have reached the limit dose of prior treatment with cardiotoxic drugs.
* Major surgical procedures within 28 days prior to first dose of study treatment.
* 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.
* Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
* Diagnostic Assessments

* 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, with exceptions defined in the protocol.
* 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 by a 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.
* Contraception requirements for male and female participants receiving SOC therapies are based on regional prescribing information.
* Breastfeeding restrictions for female participants receiving SOC therapies are based on regional prescribing information.
* 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 that would pose a risk to the subject safety or interfere with the study evaluation..

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2027
Actual
Sample size
Target
Accrual to date
Final
509
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Calvary Mater Newcastle Hospital - Waratah
Recruitment hospital [3] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Alaska
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Arkansas
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California
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Indiana
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Iowa
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United States of America
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Kentucky
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Louisiana
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Michigan
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Minnesota
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Missouri
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New Jersey
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New York
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North Dakota
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United States of America
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South Dakota
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United States of America
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Tennessee
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United States of America
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Virginia
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Washington
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United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Córdoba
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Argentina
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Río Negro
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Argentina
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Santa Fe
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Austria
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Graz
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Austria
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Krems
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Belgium
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Gent
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Hasselt
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Roeselare
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Sint-Niklaas
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Bahia
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Rio Grande Do Norte
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Rio Grande Do Sul
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Brno
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Olomouc
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Ostrava-Vitkovice
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Limoges Cedex
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Lyon
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Marseille Cedex 20
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Paris
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Pierre-Benite cedex
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France
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Rennes Cedex 9
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Strasbourg Cedex
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France
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Toulouse Cedex 9
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France
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Villejuif
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Essen
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Germany
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Gauting
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Germany
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Grosshansdorf
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Germany
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Koeln
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Germany
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Stuttgart
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Germany
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Wuerzburg
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Greece
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Athens
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Greece
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Heraklion - Crete
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Greece
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Patra
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Greece
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Thessaloniki
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Hungary
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Budapest
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Hungary
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Gyongyos
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Hungary
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Szekesfehervar
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Hungary
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Tatabanya
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Hungary
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Torokbalint
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Ireland
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Dublin
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Petah Tikva
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Italy
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Bergamo
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Italy
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Catanzaro
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Italy
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Genova
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Italy
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Meldola (FC)
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Italy
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Orbassano
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Italy
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Roma
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Ehime
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Fukuoka
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Hokkaido
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Hyogo
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Kanagawa
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Niigata
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Okayama
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Osaka
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Saitama
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Shizuoka
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Tokyo
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Wakayama
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Korea, Republic of
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Cheongju Chungbuk
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Korea, Republic of
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Goyang-si Gyeonggi-do
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Korea, Republic of
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Incheon
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Korea, Republic of
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Jinju-si
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Korea, Republic of
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Seongnam-si, Gyeonggi-do
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Korea, Republic of
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Seoul
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Korea, Republic of
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Ulsan
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Malaysia
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Pahang
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Malaysia
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Sarawak
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Malaysia
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Wilayah Persekutuan
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Mexico
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Distrito Federal
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Mexico
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Jalisco
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Netherlands
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Groningen
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Netherlands
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Leiden
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Netherlands
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Rotterdam
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Netherlands
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Utrecht
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Poland
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Bystra
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Poland
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Krakow
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Poland
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Poznan
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Portugal
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Lisboa
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Portugal
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Matosinhos
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Portugal
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Porto
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Romania
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Cluj Napoca
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Romania
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Craiova
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Romania
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Iasi
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Romania
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Timisoara
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Singapore
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Singapore
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Spain
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Aragón
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Spain
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Cataluña
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Spain
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Galicia
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Spain
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Madrid
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Switzerland
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Chur
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Switzerland
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Fribourg
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Switzerland
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Geneve 14
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Switzerland
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Sankt Gallen
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Switzerland
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Winterthur
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
Country [157] 0 0
Taiwan
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Taipei
Country [158] 0 0
Turkey
State/province [158] 0 0
Ankara
Country [159] 0 0
Turkey
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Denizli
Country [160] 0 0
Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Malatya
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United Kingdom
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London
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United Kingdom
State/province [164] 0 0
Manchester

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

Ethics approval
Ethics application status

Summary
Brief summary
The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS).
Trial website
https://clinicaltrials.gov/study/NCT05740566
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05740566