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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06593522




Registration number
NCT06593522
Ethics application status
Date submitted
3/09/2024
Date registered
19/09/2024

Titles & IDs
Public title
A Phase 2 Study of AMG 193 in Participants With MTAP-deleted Advanced NSCLC
Scientific title
A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 193 in Subjects With Methylthioadenosine Phosphorylase (MTAP)-Deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)
Secondary ID [1] 0 0
20230153
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
MTAP-deleted NSCLC 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMG 193

Experimental: Part 1: Dose Evaluation - Participants will be randomized to receive one of 2 active dose levels of AMG 193 orally (PO) daily (QD) in 28 days cycles. Part 1 of the study will determine the recommended phase 2 dose (RP2D).

Experimental: Part 2: Dose Expansion - Participants will receive AMG 193 PO QD in 28-day cycles at the RP2D.


Treatment: Drugs: AMG 193
Film-coated tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response (OR) per RECIST 1.1
Timepoint [1] 0 0
Up to 35 months
Primary outcome [2] 0 0
Objective response (OR) Measured by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) and Assessed per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)
Timepoint [2] 0 0
Up to 35 months
Primary outcome [3] 0 0
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timepoint [3] 0 0
Up to 35 months
Primary outcome [4] 0 0
Number of Participants Experiencing Events of Interest (EOIs)
Timepoint [4] 0 0
Up to 35 months
Primary outcome [5] 0 0
Maximum Concentration (Cmax) of AMG 193
Timepoint [5] 0 0
Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose
Primary outcome [6] 0 0
Time to Cmax (Tmax) of AMG 193
Timepoint [6] 0 0
Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose
Primary outcome [7] 0 0
Area Under The Concentration-time Curve (AUC) of AMG 193
Timepoint [7] 0 0
Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose
Secondary outcome [1] 0 0
Disease Control (DC) by BICR
Timepoint [1] 0 0
Up to 35 months
Secondary outcome [2] 0 0
Duration of Response (DOR) by BICR
Timepoint [2] 0 0
Up to 35 months
Secondary outcome [3] 0 0
Time to Response (TTR) by BICR
Timepoint [3] 0 0
Up to 35 months
Secondary outcome [4] 0 0
Progression-free Survival (PFS) by BICR
Timepoint [4] 0 0
Up to 35 months
Secondary outcome [5] 0 0
OR by Investigator's Assessment
Timepoint [5] 0 0
Up to 35 months
Secondary outcome [6] 0 0
DC by Investigator's Assessment
Timepoint [6] 0 0
Up to 35 months
Secondary outcome [7] 0 0
DOR by Investigator's Assessment
Timepoint [7] 0 0
Up to 35 months
Secondary outcome [8] 0 0
TTR by Investigator's Assessment
Timepoint [8] 0 0
Up to 35 months
Secondary outcome [9] 0 0
PFS by Investigator's Assessment
Timepoint [9] 0 0
Up to 35 months
Secondary outcome [10] 0 0
Overall Survival (OS)
Timepoint [10] 0 0
Up to 35 months
Secondary outcome [11] 0 0
Number of Participants Experiencing TEAEs
Timepoint [11] 0 0
Up to 35 months
Secondary outcome [12] 0 0
Cmax of AMG 193
Timepoint [12] 0 0
Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose
Secondary outcome [13] 0 0
Tmax of AMG 193
Timepoint [13] 0 0
Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose
Secondary outcome [14] 0 0
AUC of AMG 193
Timepoint [14] 0 0
Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose
Secondary outcome [15] 0 0
Change in Quality of life (QoL) per The European Organization for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ)-C30
Timepoint [15] 0 0
Up to 12 months
Secondary outcome [16] 0 0
Change in QoL per Quality of Life Questionnaire-Lung Cancer 13 (QLQ LC13)
Timepoint [16] 0 0
Up to 12 months
Secondary outcome [17] 0 0
Change in QoL per European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L)
Timepoint [17] 0 0
Up to 12 months
Secondary outcome [18] 0 0
Overall Health Status per Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Timepoint [18] 0 0
Up to 12 months
Secondary outcome [19] 0 0
Overall Health Status per The Functional Assessment of Cancer Therapy - General (FACT-G)
Timepoint [19] 0 0
Up to 12 months

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed metastatic or unresectable locally advanced MTAP-deleted (Homozygous deletion of MTAP in the tumor tissue) non-small cell lung cancer
* Participants will have received and progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease.
* Either an archival tissue sample or an archival block must be available.
* Life expectancy of greater than 3 months, in the opinion of the investigator.
* Participants who have had brain metastases and have been appropriately treated with radiation therapy or surgery ending at least 14 days before study day 1 are eligible.
* Participants with untreated asymptomatic brain metastases smaller or equal to 2 cm in size (per lesion if more than one) and not requiring corticosteroid treatment are eligible.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Disease Related

• Tumors harboring the following mutations amenable to targeted therapies: epidermal growth factor receptor (EGFR), ALK receptor tyrosine kinase (ALK), ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), MET proto-oncogene (MET), B-Raf proto-oncogene (BRAF), RET proto-oncogene (RET), Human epidermal growth factor receptor 2 (HER2), KRAS proto-oncogene (KRAS).

Other Medical Conditions

* Major surgery within 28 days of study day 1.
* Untreated symptomatic central nervous system (CNS) metastatic disease regardless of size or asymptomatic brain metastases greater than 2 cm per lesion.

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
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
28/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/02/2029
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GenesisCare -North Shore Oncology - St Leonards
Recruitment hospital [2] 0 0
Calvary Mater Newcastle Hospital - Waratah
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
2298 - Waratah
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
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
Singapore
State/province [6] 0 0
Singapore

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: 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/NCT06593522