RecruitingNon Small Cell Lung Cancer

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)

Eligible age

18+ yrs

Accepts

All genders

Locations

29 states

Healthy volunteers

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About this study

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 Teliso-V or Docetax at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 698 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.

Sponsor: AbbVie

You may qualify if…

✓ 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 actionable EGFR activating mutations are not eligible
✓ Actionable alterations in genes other than EGFR are eligible.

You may not qualify if…

✕ 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 investigator. Additionally, participants must not be receiving any ongoing anti-cancer therapy, including maintenance therapy, prior to randomization..