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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05513703




Registration number
NCT05513703
Ethics application status
Date submitted
23/08/2022
Date registered
24/08/2022

Titles & IDs
Public title
A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Scientific title
Phase 2, Open-Label Study in Subjects With Previously Untreated MET Amplified Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Secondary ID [1] 0 0
2022-500608-23-00
Secondary ID [2] 0 0
M22-137
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
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: Other - Telisotuzumab Vedotin

Experimental: Telisotuzumab Vedotin - Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.


Treatment: Other: Telisotuzumab Vedotin
Intravenous (IV) Infusion
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR) as Assessed by an Independent Central Review (ICR)
Timepoint [1] 0 0
Up to 1 Year
Secondary outcome [1] 0 0
Duration of Response (DoR)
Timepoint [1] 0 0
Up to 1 Year
Secondary outcome [2] 0 0
Disease Control Rate (DCR)
Timepoint [2] 0 0
Up to 1 Year
Secondary outcome [3] 0 0
Progression Free Survival (PFS) per ICR
Timepoint [3] 0 0
Up to 1 Year
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
Up to 2 Years
Secondary outcome [5] 0 0
Time to Deterioration in Cough
Timepoint [5] 0 0
Up to 1 Year
Secondary outcome [6] 0 0
Time to Deterioration in Pain
Timepoint [6] 0 0
Up to 1 Year
Secondary outcome [7] 0 0
Time to Deterioration in Dyspnea
Timepoint [7] 0 0
Up to 1 Year
Secondary outcome [8] 0 0
Time to Deterioration of Physical Functioning
Timepoint [8] 0 0
Up to 1 Year
Secondary outcome [9] 0 0
Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Timepoint [9] 0 0
Up to 1 Year

Eligibility
Key inclusion criteria
* Must have MET amplification in tumor tissue as determined by the Sponsor-designated central laboratory MET FISH Assay or in plasma and/or tissue by a Sponsor-approved assay.
* Must have histologically documented non-squamous adenocarcinoma non-small cell lung cancer (NSCLC) that is locally advanced or metastatic.
* Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
* Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Participant may have received prior adjuvant/neoadjuvant systemic chemotherapy and/or radiation and/or immunotherapy provided that the subject has not progressed on or within 6 months of completing the regimen and it was completed >= 6 months before subject's first dose of study drug.
* Metastases to the central nervous system (CNS) are eligible only after definitive therapy is provided as noted in the protocol.
* History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Alterations in EGFR, ALK, ROS1, or BRAF that predict sensitivity to available targeted therapy. Participants with other alterations that are candidates for available targeted therapy.
* Prior systemic therapy for locally advanced/metastatic NSCLC. Of note, limited treatment with no more than 1 cycle of chemotherapy is allowed prior to receiving the first dose of study drug provided there is no evidence of progression.
* Have a history of other malignancies except those noted in the protocol.
* Have a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
* Received prior c-Met-targeted antibodies.
* Have NSCLC that is eligible for treatment with curative intent.
* Have unresolved adverse events (AEs) >= Grade 2 from prior anticancer therapy, except for alopecia or anemia.
* Have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
* Have clinically significant condition(s) as noted in the protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Single group
Other design features
Phase
Phase 2
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
21/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre /ID# 247679 - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton
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
Washington
Country [3] 0 0
France
State/province [3] 0 0
Hauts-de-France
Country [4] 0 0
France
State/province [4] 0 0
Rhone
Country [5] 0 0
France
State/province [5] 0 0
Clermont Ferrand
Country [6] 0 0
Germany
State/province [6] 0 0
Gauting
Country [7] 0 0
Israel
State/province [7] 0 0
H_efa
Country [8] 0 0
Israel
State/province [8] 0 0
HaMerkaz
Country [9] 0 0
Israel
State/province [9] 0 0
Tel-Aviv
Country [10] 0 0
Israel
State/province [10] 0 0
Yerushalayim
Country [11] 0 0
Italy
State/province [11] 0 0
Monza E Brianza
Country [12] 0 0
Italy
State/province [12] 0 0
Torino
Country [13] 0 0
Italy
State/province [13] 0 0
Rome
Country [14] 0 0
Japan
State/province [14] 0 0
Chiba
Country [15] 0 0
Japan
State/province [15] 0 0
Fukuoka
Country [16] 0 0
Japan
State/province [16] 0 0
Hokkaido
Country [17] 0 0
Japan
State/province [17] 0 0
Osaka
Country [18] 0 0
Japan
State/province [18] 0 0
Shizuoka
Country [19] 0 0
Japan
State/province [19] 0 0
Tokyo
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Gyeongsangnamdo
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Cheongju
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Daegu
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Seoul
Country [24] 0 0
Taiwan
State/province [24] 0 0
Kaohsiung
Country [25] 0 0
Taiwan
State/province [25] 0 0
Tainan
Country [26] 0 0
Taiwan
State/province [26] 0 0
Taoyuan City

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
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?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


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/NCT05513703