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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03319940




Registration number
NCT03319940
Ethics application status
Date submitted
5/10/2017
Date registered
24/10/2017

Titles & IDs
Public title
Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)
Scientific title
A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of Tarlatamab in Subjects With Small Cell Lung Cancer (DeLLphi-300)
Secondary ID [1] 0 0
20160323
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Small Cell Lung Carcinoma 0 0
Condition category
Condition code
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 - Pembrolizumab
Treatment: Drugs - CRS Mitigation Strategies

Experimental: Part A - Tarlatamab monotherapy

Experimental: Part C - Tarlatamab with Pembrolizumab

Experimental: Part D - Tarlatamab with additional CRS mitigation strategies

Experimental: Part E - Tarlatamab administration with 24-hour monitoring

Experimental: Part F - Tarlatamab administered in outpatient infusion centers with 8-hour monitoring

Optional wearable digital device substudy (US sites only)

Experimental: Part G - Tarlatamab additional dosing schedule

Optional wearable digital device substudy (US sites only)


Treatment: Drugs: Tarlatamab
Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)

Treatment: Drugs: Pembrolizumab
Pembrolizumab is a potent humanized IgG4 monoclonal antibody (mAb) with high specificity of binding to the PD-1 receptor, thus inhibiting its interaction with PD-L1 and PD-L2

Treatment: Drugs: CRS Mitigation Strategies
Participants will be treated with one of the CRS mitigation strategies.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with dose limiting toxicities (DLT) for all indications
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Number of participants with treatment-emergent adverse events (AEs) for all indications
Timepoint [2] 0 0
4 years
Primary outcome [3] 0 0
Number of participants with treatment-related AEs for all indications
Timepoint [3] 0 0
4 years
Primary outcome [4] 0 0
Number of participants with clinically significant changes in vital signs for all indications
Timepoint [4] 0 0
4 years
Primary outcome [5] 0 0
Number of participants with significant changes in electrocardiogram (ECG) for all indications
Timepoint [5] 0 0
4 years
Primary outcome [6] 0 0
Number of participants with significant changes in physical examinations for all indications
Timepoint [6] 0 0
4 years
Primary outcome [7] 0 0
Number of participants with significant changes in clinical laboratory tests for all indications
Timepoint [7] 0 0
4 years
Secondary outcome [1] 0 0
Maximum observed concentration (Cmax) following intravenous administration for all indications
Timepoint [1] 0 0
4 years
Secondary outcome [2] 0 0
Minimum observed concentration (Cmin) following intravenous administration for all indications
Timepoint [2] 0 0
4 years
Secondary outcome [3] 0 0
Area under the concentration-time curve (AUC) over the 2 week dosing interval for all indications
Timepoint [3] 0 0
4 years
Secondary outcome [4] 0 0
Accumulation following multiple dosing for all indications
Timepoint [4] 0 0
4 years
Secondary outcome [5] 0 0
Half-life (t1/2) following intravenous administration for all indications
Timepoint [5] 0 0
4 years
Secondary outcome [6] 0 0
Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Timepoint [6] 0 0
4 years
Secondary outcome [7] 0 0
Duration of Response (DOR) for all indications
Timepoint [7] 0 0
4 years
Secondary outcome [8] 0 0
Time to Response (TTR)
Timepoint [8] 0 0
4 years
Secondary outcome [9] 0 0
9-month Progression-Free Survival (PFS) for all indications
Timepoint [9] 0 0
9 months
Secondary outcome [10] 0 0
9-month Overall Survival (OS) for all indications
Timepoint [10] 0 0
9 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 time of signing the informed consent
* Histologically or cytologically confirmed SCLC. For parts A, C, D, E, F, and G: relapsed/refractory small cell lung cancer (R/R SCLC) who progressed or recurred following platinum-based regimen
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Participants with treated 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 prior to first dose of tarlatamab with exceptions
* Major surgery within 28 days of first dose tarlatamab
* Untreated (includes new lesions or progression in previously treated lesions) or symptomatic brain metastases and leptomeningeal disease (regardless of symptomatic or not).
* Prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of tarlatamab with the following exceptions: participants who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade less than or equal to 1; and prior palliative radiotherapy must have been completed at least 7 days before the first dose of tarlatamab
* Participants who experienced severe, life-threatening or recurrent (Grade 2 or higher) immune-mediated AEs or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immune-oncology agents
* Has 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 tarlatamab
* Part C only: history of solid organ transplantation or active autoimmune disease that has required systemic treatment within the past 2 years
* 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 investigational product administration

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/04/2026
Actual
Sample size
Target
Accrual to date
Final
269
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
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
Austria
State/province [14] 0 0
Graz
Country [15] 0 0
Austria
State/province [15] 0 0
Salzburg
Country [16] 0 0
France
State/province [16] 0 0
Villejuif
Country [17] 0 0
Germany
State/province [17] 0 0
Wuerzburg
Country [18] 0 0
Hong Kong
State/province [18] 0 0
Shatin, New Territories
Country [19] 0 0
Japan
State/province [19] 0 0
Chiba
Country [20] 0 0
Japan
State/province [20] 0 0
Tokyo
Country [21] 0 0
Japan
State/province [21] 0 0
Wakayama
Country [22] 0 0
Netherlands
State/province [22] 0 0
Amsterdam
Country [23] 0 0
Netherlands
State/province [23] 0 0
Maastricht
Country [24] 0 0
Poland
State/province [24] 0 0
Jozefow
Country [25] 0 0
Poland
State/province [25] 0 0
Otwock
Country [26] 0 0
Spain
State/province [26] 0 0
Cataluña
Country [27] 0 0
Spain
State/province [27] 0 0
Madrid
Country [28] 0 0
Switzerland
State/province [28] 0 0
Lausanne
Country [29] 0 0
Switzerland
State/province [29] 0 0
Sankt Gallen
Country [30] 0 0
Taiwan
State/province [30] 0 0
Kaohsiung
Country [31] 0 0
Taiwan
State/province [31] 0 0
Taipei
Country [32] 0 0
Taiwan
State/province [32] 0 0
Taoyuan
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Manchester

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/NCT03319940