Metropolitan Hospital | 4th Oncology Department
Status and phase
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About
This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that overexpress c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage 2). After the Stage 2 global enrollment is completed, an additional cohort at an alternate dose level will evaluate the safety and efficacy of telisotuzumab vedotin (Stage 3).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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:
Primary purpose
Allocation
Interventional model
Masking
270 participants in 1 patient group
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Central trial contact
ABBVIE CALL CENTER
Data sourced from clinicaltrials.gov
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