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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04928846




Registration number
NCT04928846
Ethics application status
Date submitted
14/06/2021
Date registered
16/06/2021

Titles & IDs
Public title
A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Scientific title
A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
2023-505749-14-00
Secondary ID [2] 0 0
M18-868
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
Treatment: Drugs - Docetaxel

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

Active comparator: Docetaxel - Participants will receive docetaxel every 3 weeks until meeting study drug discontinuation criteria.


Treatment: Other: Telisotuzumab Vedotin
Intravenous (IV) Infusion

Treatment: Drugs: Docetaxel
IV Infusion
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
Up to approximately 39 months
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to approximately 39 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR), per BICR.
Timepoint [1] 0 0
Up to approximately 58.25 months
Secondary outcome [2] 0 0
Duration of Response (DoR), per BICR
Timepoint [2] 0 0
Up to approximately 58.25 months
Secondary outcome [3] 0 0
PFS per Investigator Assessment
Timepoint [3] 0 0
Up to approximately 58.25 months
Secondary outcome [4] 0 0
Change from Baseline of Physical Functioning as measured by the Physical Functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30).
Timepoint [4] 0 0
Up to approximately 12 Weeks
Secondary outcome [5] 0 0
Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-C30.
Timepoint [5] 0 0
Up to approximately 12 Weeks

Eligibility
Key inclusion criteria
* Projected life expectancy of at least 12 weeks.
* Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay.
* Archival or fresh tumor material must be submitted for assessment of c-Met levels during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed.

* If a participant was prescreened for Study M14-239 but did not enroll, tumor material previously submitted for Study M14-239 may be used for Study M18-868 Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor material is available (Except China).
* A histologically or cytologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
* A known epidermal growth factor receptor (EGFR) activating mutation status.
* Actionable alterations in genes other than EGFR .
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
* An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
* Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting.

* Neoadjuvant and adjuvant systemic cytotoxic chemotherapy will count as a prior line for eligibility purposes if progression occurred within 6 months of the end of therapy.
* Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC:

* Participants WITHOUT an actionable gene alteration: must have progressed on (or be considered ineligible for) platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
* Participants WITH an actionable gene alteration for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase [ALK] translocation): must have progressed on (or be considered ineligible for) anti-cancer therapy targeting driver gene alterations and platinum-based chemotherapy.

* Participants with actionable gene alterations for which immune checkpoint inhibitor is standard of care must have also progressed on (or be considered ineligible for) immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
* Must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.
* Participants with metastases to the central nervous system (CNS) are eligible only after adequate treatment (such as surgery, radiotherapy, or drug therapy) is provided and:

* They are asymptomatic and off or on a stable or reducing dose of systemic steroids (on no more than 10 mg per day [QD] prednisone or equivalent) and/or anticonvulsants for at least 2 weeks prior to randomization.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Evidence of new, untreated CNS metastases.
* Evidence of leptomeningeal disease.
* Participants with adenosquamous or neuroendocrine histology, nor sarcomatoid features.
* Actionable epidermal growth factor receptor (EGFR) activating mutations.
* Participants who have received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E..
* Participants who have received prior docetaxel therapy.
* A history of other malignancies except:

* Malignancy treated with curative intent and with no known active disease present for >=2 years before the first dose of study drug and felt to be at low risk for recurrence by investigator.
* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
* Adequately treated carcinoma in situ without current evidence of disease.
* 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. A history of prior radiation pneumonitis in the radiation field (fibrosis) is permitted.
* Unresolved or neuroendocrine histology, nor sarcomatoid features adverse event (AE) >= Grade 2 from prior anticancer therapy, except for alopecia or anemia. Participants with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for study.
* Major surgery within 21 days prior to randomization.
* Clinically significant condition(s) as listed in the protocol.

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
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/03/2028
Actual
Sample size
Target
698
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Barwon Health /ID# 241920 - Geelong
Recruitment hospital [2] 0 0
Austin Health /ID# 247507 - Heidelberg
Recruitment postcode(s) [1] 0 0
3220 - Geelong
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Arizona
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California
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Michigan
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North Carolina
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Ohio
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South Carolina
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Utah
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Washington
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Argentina
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Ciudad Autonoma De Buenos Aires
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Rio Negro
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Maule
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Jilin
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Liaoning
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Zhejiang
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Czechia
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Praha 17
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Brno
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Hessen
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Germany
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Thueringen
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Hamburg
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HaDarom
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Israel
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Italy
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L Aquila
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Italy
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Milano
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Italy
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Roma
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Italy
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Umbria
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Italy
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Messina
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Italy
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Napoli
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Italy
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Aichi
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Aomori
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Chiba
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Fukui
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Fukuoka
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Ibaraki
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Iwate
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Kanagawa
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Kumamoto
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Mie
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Miyagi
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Miyazaki
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Niigata
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Okayama
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Osaka
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Tochigi
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Tokyo
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Toyama
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Japan
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Wakayama
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Japan
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Yamagata
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Japan
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Yamaguchi
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Korea, Republic of
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Chungcheongbugdo
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Gyeongsangnamdo
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Korea, Republic of
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Seoul Teugbyeolsi
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Mexico
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Jalisco
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Mexico
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Mexico
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Oaxaca
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Netherlands
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Zuid-Holland
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Poland
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Lodzkie
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Podkarpackie
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Warminsko-mazurskie
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Portugal
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Lisboa
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Portugal
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Regiao Autonoma Da Madeira
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Portugal
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Porto
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Romania
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Bihor
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Romania
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Cluj
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Romania
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Iasi
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Romania
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Ilfov
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Romania
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Olt
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Timis
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Suceava
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Slovakia
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Bratislavsky Kraj
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South Africa
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Gauteng
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Burgos
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Las Palmas
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Barcelona
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Spain
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Jaen
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Spain
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Valencia
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Sweden
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Stockholms Lan
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Sweden
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Vastra Gotalands Lan
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Taiwan
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Keelung
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Taipei
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Taiwan
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Changhua City, Changhua County
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Taiwan
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Hsinchu City
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Taiwan
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Hualien City
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Taiwan
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Taipei City
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Izmir
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Turkey
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Battalgazi/malatya
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Turkey
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Bursa
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Turkey
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Diyarbakir
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Turkey
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Istanbul
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United Kingdom
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London, City Of
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United Kingdom
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Nottinghamshire
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United Kingdom
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Birmingham
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United Kingdom
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London
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United Kingdom
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Manchester

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
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
[email protected]
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 clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

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?
To learn more about 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/NCT04928846