Comparing Telisotuzumab Vedotin with Docetaxel for non small cell lung cancer
Official 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)
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
Interventions
Telisotuzumab Vedotin
Intravenous (IV) Infusion
Docetaxel
IV Infusion
Canadian Sites (5)
Cross Cancer Institute. /ID# 252065
Edmonton, Alberta, Canada
William Osler Health System - Brampton Civic Hospital /ID# 254420
Brampton, Ontario, Canada
CISSS de la Monteregie /ID# 239081
Greenfield Park, Quebec, Canada
CSSS Alphonse-Desjardins, CHAU de Levis /ID# 261158
Lévis, Quebec, Canada
Hopital Du Sacre-Coeur De Montreal /ID# 274584
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for32 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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-ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more → upon confirmation from AbbVie that sufficient evaluable tumor material is available (Except China).
- +An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- +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.
- +\-- Participants with EGFR activating mutations are not eligible
- +Projected life expectancy of at least 12 weeks.
- +Archival or fresh tumor material must be submitted for assessment of c-Met protein expression levels during the Pre-Screening period. Tumor material from the primary tumor siteTrial siteA hospital or clinic where a study is actually run.Read more → and/or metastatic sites are allowed.
- +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 are eligible.
- +Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- +Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC
- +Must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.
- +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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- +Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting.
- +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 careStandard of careThe treatment normally given for a condition outside a study.Read more → (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 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).
- +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:
Exclusion
- −Evidence of new, untreated CNS metastases or progressing CNS metastases after treatment.
- −Evidence of leptomeningeal disease.
- −Participants with adenosquamous or neuroendocrine histology, nor sarcomatoid features.
- −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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →. Additionally, participants must not be receiving any ongoing anti-cancer therapy, including maintenance therapy, prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →..
- −Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- −Adequately treated carcinoma in situ without current evidence of disease.
- −Unresolved nor adverse eventAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (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.
- −Clinically significant condition(s) as listed in the protocolProtocolThe detailed plan a study must follow.Read more →.
- −A history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, evidence of active pneumonitis on screeningScreeningThe checks done before joining, to see whether a study fits.Read more → chest computed tomography (CT) scan or prior pneumonectomy. A history of prior radiation pneumonitis in the radiation field (fibrosis) is not permitted.
- −Major surgery within 21 days prior to randomization.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Telisotuzumab Vedotin, Docetaxel.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 768 people.
The study is currently expected to finish around February 2029.
The main measurement is taken over: Up to approximately 39 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR) — measured over Up to approximately 39 months.
Overall Survival (OS) — measured over Up to approximately 39 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04928846 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Telisotuzumab VedotinBiological
Intravenous (IV) Infusion
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About DocetaxelDrug
IV Infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to approximately 39 months.
The study as a whole is currently expected to finish around 2029-02.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 768 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 12 locations, including: Edmonton, Alberta, Canada; Brampton, Ontario, Canada; Greenfield Park, Quebec, Canada; Lévis, Quebec, Canada; Montreal, Quebec, Canada; Ypsilanti, Michigan, United States, and 6 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. Change in disease activity and adverse events will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of telisotuzumab vedotin or docetaxel at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 768 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 330 sites worldwide. Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria. At the conclusion of the study, participants who continue to demonstrate clinical benefit may be eligible to receive study treatment via an extension of the study, a rollover study, or through another mechanism. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Other Sites (7)
Trinity Health St. Joseph Mercy Ann Arbor /ID# 232190
Ypsilanti, Michigan, United States
Mayo Clinic - Rochester /ID# 252052
Rochester, Minnesota, United States
Intermountain Health St Vincent Regional Hospital - Cancer Centers of Montana /ID# 253147
Billings, Montana, United States
Maimonides Medical Center /ID# 240783
Brooklyn, New York, United States
Northwell Health - Monter Cancer Center /ID# 247081
Lake Success, New York, United States
Valley Medical Center /ID# 253950
Renton, Washington, United States
Medical Oncology Associates /ID# 247003
Spokane, Washington, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.