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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04822298




Registration number
NCT04822298
Ethics application status
Date submitted
26/03/2021
Date registered
30/03/2021

Titles & IDs
Public title
Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer
Scientific title
A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 160 in Subjects With Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
20180273
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
NSCLC 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 - AMG 160

Experimental: Part 1: Dose Exploration - The dose exploration part of the study will estimate the MTD and/or the RP2D.

Experimental: Part 2: Dose Expansion - Cohort 1 Non-squamous NSCLC - Participants with non-squamous non-small cell lung cancer (NSCLC) will be administered the RP2D identified from the dose exploration part of the study.

Experimental: Part 2: Dose Expansion - Cohort 2 Squamous NSCLC - Participants with squamous NSCLC will be administered the RP2D identified from the dose exploration part of the study.


Treatment: Drugs: AMG 160
AMG 160 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 Who Experience One or More Dose-limiting Toxicities (DLT)
Timepoint [1] 0 0
Day 1 to Day 28
Primary outcome [2] 0 0
Number of Participants Who Experience One or More Treatment-emergent AE (TEAE)
Timepoint [2] 0 0
Median (min, max) time from first dose to 30 days after the last dose, end of study or start of new anti-cancer therapy; whichever is earlier, was 66 (52, 100) days
Secondary outcome [1] 0 0
Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timepoint [1] 0 0
Median (min, max) time from first dose to end of study was 100 (94, 122) days
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Median (min, max) time from first dose to end of study was 100 (94, 122) days
Secondary outcome [3] 0 0
Radiographic Progression Free Survival (PFS) Per Modified RECIST v1.1
Timepoint [3] 0 0
Median (min, max) time from first dose to end of study was 100 (94, 122) days
Secondary outcome [4] 0 0
Clinical PFS Per Modified RECIST v1.1
Timepoint [4] 0 0
Median (min, max) time from first dose to end of study was 100 (94, 122) days
Secondary outcome [5] 0 0
Time to Response Per Modified RECIST v1.1
Timepoint [5] 0 0
Median (min, max) time from first dose to end of study was 100 (94, 122) days
Secondary outcome [6] 0 0
Time to Progression Per Modified RECIST v1.1
Timepoint [6] 0 0
Median (min, max) time from first dose to end of study was 100 (94, 122) days
Secondary outcome [7] 0 0
Time to Clinical Progression
Timepoint [7] 0 0
Median (min, max) time from first dose to end of study was 100 (94, 122) days
Secondary outcome [8] 0 0
Duration of Response (DOR) Per Modified RECIST v1.1
Timepoint [8] 0 0
Median (min, max) time from first dose to end of study was 100 (94, 122) days
Secondary outcome [9] 0 0
Time to Subsequent Therapy
Timepoint [9] 0 0
Median (min, max) time from first dose to end of study was 100 (94, 122) days

Eligibility
Key inclusion criteria
* Participant has provided informed consent prior to initiation of any study specific activities/procedures.
* Histologically or cytologically confirmed stage 4 or recurrent non-squamous NSCLC (Part 1); histologically or cytologically. confirmed stage 4 or recurrent NSCLC (Part 2 only, squamous cell histology/cytology allowed in Part 2).
* Without a driver mutation: disease progression following at least one line of prior chemotherapy and at least 1 prior anti-programmed cell death protein 1 (PD1)/programmed death-ligand 1 (PDL1) therapy.
* With a driver mutation must experience disease progression on at least 1 targeted therapeutic agent to be eligible.
* Detectable prostate-specific membrane antigen (PSMA) expression by PSMA positron emission tomography (PET)/computed tomography (CT) imaging.
* Measurable disease by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0- 2.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Radiographic evidence of intratumor cavitation, major blood vessel invasion or encasement by cancer.
* Untreated or symptomatic brain metastases and leptomeningeal disease.
* History of hemoptysis within 3 months prior to first dose.
* History or evidence of gastrointestinal inflammatory bowel disease (ulcerative colitis or Crohn disease).
* Myocardial infarction, unstable angina, cardiac arrhythmias requiring medication, and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months prior to start of dosing.
* Vasculitis or grade 3/4 gastrointestinal bleeding within 3 months prior to first dose; vascular disease (eg, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months of first dose.
* Gastrointestinal (GI) perforation and/or fistulae within 6 months prior to start of dosing.
* Interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with treatment.
* Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).
* Chronic systemic corticosteroid therapy or any other immunosuppressive therapies unless stopped 7 days prior to first dose.
* Any biological therapy or immunotherapy within 3 weeks of start of first dose.
* Major surgery within 4 weeks of first dose.
* Infection requiring IV antimicrobials for management within 7 days of dosing.
* Known human immunodeficiency virus (HIV) infection, hepatitis C infection.
* Active autoimmune disease

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
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/01/2022
Sample size
Target
Accrual to date
Final
3
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
Texas
Country [2] 0 0
Austria
State/province [2] 0 0
Salzburg
Country [3] 0 0
Austria
State/province [3] 0 0
Wien

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04822298