Anetumab Ravtansine and Atezolizumab in Treating Participants With Advanced Non-small Cell Lung C… (NCT03455556) | Clinical Trial Compass
TerminatedPhase 1
Anetumab Ravtansine and Atezolizumab in Treating Participants With Advanced Non-small Cell Lung Cancer
Stopped: slow accrual
United States1 participantsStarted 2018-08-10
Plain-language summary
This phase I/II trial studies the best dose and side effects of anetumab ravtansine when given together with atezolizumab and how well they work in treating participants with non-small cell lung cancer that has spread to other places in the body. Monoclonal antibodies, such as anetumab ravtansine and atezolizumab, may interfere with the ability of tumor cells to grow and spread.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* PRE REGISTRATION ? INCLUSION CRITERIA: Ability to understand and the willingness to sign a written informed consent document
* PRE REGISTRATION ? INCLUSION CRITERIA: Patient has disease amenable to biopsy if the archival tissue sample is unavailable; note: Archive sample must not be older than 12 months
* REGISTRATION ? INCLUSION CRITERIA
* Phase I only: Diagnosis of advanced/metastatic NSCLC for which no standard treatment option; Phase II only: Advanced NSCLC patients who have received at least 1 platinum-based systemic chemotherapy regimen
* Patients with tumors having actionable genomic alterations should have received prior therapy with Food and Drug Administration (FDA) approved agents targeting these aberrations (ie EGFR, ALK, ROS1, BRAF V600E)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Phase II only: Must have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* Ability to understand and the willingness to sign a written informed consent document
* Histological or cytologically confirmed NSCLC that shows moderate or stronger mesothelin expression in 30% of tumor cells by a companion assay; MSLN expression score using Ventana immunohistochemistry (IHC) SP74 assay; Phase I only: In addition 5- 30% tumor cells and 1, 2, or 3+ MSLN score; Phase II only: 30% tumor cells and either 2+/3+
* Life expectancy of \>= 12 weeks
* Absolute neutrophil count \>= 1.5 ? 10\^9/L …