A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin C… (NCT04928846) | Clinical Trial Compass
RecruitingPhase 3
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)
United States, Argentina, Australia768 participantsStarted 2022-03-25
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 protein expression 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.
\-- Participants with EGFR activating mutations are not eligible
* Actionable alterations in genes other than EGFR are eligible.
* 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.
* Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC
* Participants WITHOUT an actionab…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 3 trial comparing telisotuzumab vedotin directly against docetaxel — does my tumor profile and treatment history make me a reasonable candidate to discuss joining this study?
2Since one arm of this trial uses docetaxel, which is already an approved second-line treatment for non-squamous NSCLC, how does my doctor weigh the potential benefit of the experimental drug against simply receiving standard docetaxel outside of a trial?
3The trial is measuring progression-free survival and overall survival as its main goals — based on earlier-phase data for telisotuzumab vedotin, what signals about safety or effectiveness should I know about before deciding whether this is worth discussing further?
4Because this is an IV infusion study comparing two intravenous treatments, what would the visit schedule and infusion time commitment look like, and is that realistic given my current health and life situation?
5Are there specific biomarker or eligibility requirements — such as c-MET protein expression levels — that my doctor would need to test for before this trial could even be considered as an option for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)