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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03539536




Registration number
NCT03539536
Ethics application status
Date submitted
17/05/2018
Date registered
29/05/2018

Titles & IDs
Public title
Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer
Scientific title
Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects With Previously Treated c-Met+ Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
2023-507902-15-00
Secondary ID [2] 0 0
M14-239
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: Drugs - Telisotuzumab vedotin

Experimental: Telisotuzumab vedotin - Telisotuzumab vedotin administered via intravenous (IV) infusion every 14 days.


Treatment: Drugs: Telisotuzumab vedotin
Intravenous (IV) infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR) (Stage 1 and Stage 2)
Timepoint [1] 0 0
Up to approximately 3 years
Primary outcome [2] 0 0
Number of Participants with Adverse Events (Alternate dose cohort)
Timepoint [2] 0 0
Up to approximately 3 years
Secondary outcome [1] 0 0
Duration of Response (DoR) (Stage 1 and Stage 2)
Timepoint [1] 0 0
Up to approximately 3 years
Secondary outcome [2] 0 0
Disease Control Rate (DCR) (Stage 1 and Stage 2)
Timepoint [2] 0 0
Up to approximately 3 years
Secondary outcome [3] 0 0
Progression-Free Survival (PFS) (Stage 1 and Stage 2)
Timepoint [3] 0 0
Up to approximately 3 years
Secondary outcome [4] 0 0
Overall Survival (OS) (Stage 1 and Stage 2)
Timepoint [4] 0 0
Up to approximately 3 years

Eligibility
Key inclusion criteria
* Have locally advanced or metastatic non-small cell lung cancer (NSCLC).
* Have c-Met+ NSCLC as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory. Participant must submit archival or fresh tumor material for assessment of c-Met levels during the prescreening period. Tumor material from the primary tumor site and/or metastatic sites are allowed. If archival tissue is negative for c-Met overexpression, subject can submit fresh biopsy material for reassessment of c-Met expression.
* Histologically documented non-squamous epidermal growth factor receptor (EGFR) wild type NSCLC (site documented EGFR status). Of note, subjects with other actionable mutations are eligible as long as EGFR status is known and all other eligibility criteria are met. As of Protocol Version 11, Stage 1 is complete and Stage 2 is enrolling participants with non-squamous EGFR wild type NSCLC only.
* Must have received no more than 2 lines of prior systemic therapy (including no more than 1 line of systemic cytotoxic chemotherapy) in the locally advanced or metastatic setting.
* Multiple lines of tyrosine kinase inhibitors (TKIs) targeting the same tyrosine kinase (TK) count as 1 line of therapy for the purposes of this eligibility criterion.
* Progressed on systemic cytotoxic therapy (or are ineligible for systemic cytotoxic chemotherapy) and an immune checkpoint inhibitor (as monotherapy or in combination with systemic cytotoxic chemotherapy, or ineligible), and prior anticancer therapies targeting driver gene alterations (if applicable).
* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
* Treatment with any therapies within the noted time intervals is excluded prior to the first dose of telisotuzumab vedotin as noted in the protocol.
* Metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided within the protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have received radiation therapy to the lungs < 6 months prior to the first dose of telisotuzumab vedotin.
* Have received any live vaccine within 30 days of the first dose of investigational product.
* Has adenosquamous histology.
* Have a history of other malignancies except those noted within the protocol.
* Have a history of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids.
* Have any evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or ILD within 3 months of the planned first dose of the study drug (Except for Sites in Ireland). For imaging findings deemed clinically insignificant by the treating physician, subject may be eligible after discussion with and approval from the AbbVie medical monitor.
* For Sites in Ireland Only: Must not have any evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or ILD. For imaging findings deemed clinically insignificant by the treating physician, subject may be eligible after discussion with and approval from the AbbVie medical monitor.
* Have a clinically significant condition(s) as noted in the protocol.
* Have unresolved clinically significant adverse events of 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.
* For Sites in France and Czech Republic Only: Have the following:

* Known human immunodeficiency virus (HIV) infection. Note: HIV testing is not required for eligibility for this protocol unless mandated by local regulatory authority or ethics committee/institutional review board.
* Active hepatitis B virus (HBV) infection, defined by hepatitis B surface antigen (HBsAg) positivity or HBV DNA >= 500 IU/mL. In participants with known HBV infection, the presence of active infection must be tested locally. If HBV status is unknown, it must be tested locally at screening.
* Active hepatitis C virus (HCV) infection, defined by HCV ribonucleic acid (RNA) positivity. Participants cured of HCV infection may be included in the study. In participants with known HCV infection, the presence of active infection must be tested locally. If HCV status is unknown, it must be tested locally at screening.
* Uncontrolled autoimmune disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
10/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
6/10/2025
Actual
Sample size
Target
Accrual to date
Final
270
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
The Kinghorn Cancer Centre /ID# 207666 - Darlinghurst
Recruitment hospital [2] 0 0
Newcastle Private Hospital /ID# 206600 - Lambton Heights
Recruitment hospital [3] 0 0
The Tweed Hospital /ID# 206601 - Tweed Heads
Recruitment hospital [4] 0 0
Mater Misericordiae Limited /ID# 229639 - South Brisbane
Recruitment hospital [5] 0 0
St John Of God Subiaco Hospital /ID# 226943 - Subiaco
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2305 - Lambton Heights
Recruitment postcode(s) [3] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
6008 - Subiaco
Recruitment outside Australia
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Antalya
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Istanbul
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Izmir
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London, City Of
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Nottinghamshire
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Oxfordshire
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Birmingham
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London

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/NCT03539536