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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05361395




Registration number
NCT05361395
Ethics application status
Date submitted
29/04/2022
Date registered
4/05/2022

Titles & IDs
Public title
First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Scientific title
A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung (DeLLphi-303)
Secondary ID [1] 0 0
2021-005462-17
Secondary ID [2] 0 0
20200469
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extensive Stage 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(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Tarlatamab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Etoposide
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Durvalumab

Experimental: Part 1: Dose Exploration Combination Regimen 1 - Tarlatamab+Atezolizumab+Carboplatin+Etoposide

Experimental: Part 2: Dose Exploration Combination Regimen 2 - Tarlatamab+Atezolizumab+Carboplatin+Etoposide

Experimental: Part 3: Dose Exploration Combination Regimen 3 - Tarlatamab+Atezolizumab+Carboplatin+Etoposide

Experimental: Part 4: Dose Expansion - Expansion of Part 1, Part 2, or Part 3 with Atezolizumab

Experimental: Part 5: Dose Exploration Maintenance - Tarlatamab+Atezolizumab

Experimental: Part 6: Dose Expansion Maintenance - Expansion of Part 5 with Atezolizumab

Experimental: Part 7: Dose Expansion - Expansion of Part 1, 2, or 3 with Durvalumab

Experimental: Part 8: Dose Expansion Maintenance - Expansion of Part 5 with Durvalumab

Experimental: Part 9: Dose Expansion Maintenance - Expansion with Tarlatamab+Durvalumab


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

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

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

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

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

Outcomes
Primary outcome [1] 0 0
Number of Participants with a Dose Limiting Toxicity (DLT)
Timepoint [1] 0 0
24 months
Primary outcome [2] 0 0
Number of Participants with Treatment-emergent Adverse Events (TEAE)
Timepoint [2] 0 0
24 months
Primary outcome [3] 0 0
Number of Participants with Treatment-related Adverse Events
Timepoint [3] 0 0
24 months
Primary outcome [4] 0 0
Number of Participants with Clinically Significant Changes in Vital Signs
Timepoint [4] 0 0
24 months
Primary outcome [5] 0 0
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements
Timepoint [5] 0 0
24 months
Primary outcome [6] 0 0
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Timepoint [6] 0 0
24 months
Secondary outcome [1] 0 0
6-month Progression-free Survival (PFS)
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Objective Response (OR)
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Disease Control Rate(DCR)
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Serum Concentration of Tarlatamab
Timepoint [6] 0 0
24 months

Eligibility
Key inclusion criteria
* Participant has provided informed consent prior to initiation of any study specific activities/procedures.
* Age greater than or equal to 18 years old at the same time of signing the informed consent.
* Histologically or cytologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC) and no prior systemic treatment for ES-SCLC.
* Participants with prior treatment for limited-stage SCLC (LS-SCLC) are permitted.
* Eastern Cooperative Oncology Group (ECOG) 0 to 1.
* Participants with treated asymptomatic brain metastases are eligible provided they meet defined criteria.
* Adequate organ function as defined in protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of other malignancy within the past 2 years with exceptions.
* Major surgery within 28 days of study day 1.
* Untreated or symptomatic brain metastases and leptomeningeal disease.
* Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
* History of immune-related colitis.
* History or evidence of interstitial lung disease or active, non-infectious pneumonitis.
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
* Participants 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
* NOTE: Simple urinary tract infections and uncomplicated bacterial pharyngitis are permitted if responding to an active treatment and after consultation with Medical Monitor. Participants requiring oral antibiotics who have been afebrile for >24 hours, have no leukocytosis, nor clinical signs of infection are eligible. Screening for chronic infectious conditions is not required.
* History of hypophysitis or pituitary dysfunction.
* History of solid organ transplantation or allogeneic hematopoietic stem cell transplantation.
* 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. Participants with Type I diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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 1
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
24/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2029
Actual
Sample size
Target
340
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Chris OBrien Lifehouse - Camperdown
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Delaware
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
South Dakota
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
United States of America
State/province [9] 0 0
West Virginia
Country [10] 0 0
Belgium
State/province [10] 0 0
Edegem
Country [11] 0 0
Belgium
State/province [11] 0 0
Gent
Country [12] 0 0
Belgium
State/province [12] 0 0
Hasselt
Country [13] 0 0
Belgium
State/province [13] 0 0
Roeselare
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Denmark
State/province [16] 0 0
Kobenhavn
Country [17] 0 0
France
State/province [17] 0 0
Lyon cedex 8
Country [18] 0 0
France
State/province [18] 0 0
Saint Herblain
Country [19] 0 0
France
State/province [19] 0 0
Villejuif
Country [20] 0 0
Germany
State/province [20] 0 0
Dresden
Country [21] 0 0
Germany
State/province [21] 0 0
Essen
Country [22] 0 0
Germany
State/province [22] 0 0
Freiburg
Country [23] 0 0
Israel
State/province [23] 0 0
Haifa
Country [24] 0 0
Israel
State/province [24] 0 0
Jerusalem
Country [25] 0 0
Israel
State/province [25] 0 0
Petah Tikva
Country [26] 0 0
Israel
State/province [26] 0 0
Ramat Gan
Country [27] 0 0
Italy
State/province [27] 0 0
Catanzaro
Country [28] 0 0
Italy
State/province [28] 0 0
Monza (MB)
Country [29] 0 0
Italy
State/province [29] 0 0
Rome
Country [30] 0 0
Japan
State/province [30] 0 0
Chiba
Country [31] 0 0
Japan
State/province [31] 0 0
Tokyo
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Seoul
Country [33] 0 0
Netherlands
State/province [33] 0 0
Groningen
Country [34] 0 0
Spain
State/province [34] 0 0
Cataluña
Country [35] 0 0
Spain
State/province [35] 0 0
Madrid
Country [36] 0 0
Switzerland
State/province [36] 0 0
Basel
Country [37] 0 0
Switzerland
State/province [37] 0 0
Bern
Country [38] 0 0
Taiwan
State/province [38] 0 0
Tainan
Country [39] 0 0
Taiwan
State/province [39] 0 0
Taipei

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/NCT05361395