Anetumab Ravtansine and Atezolizumab in Treating Participants With Advanced Non-small Cell Lung Cancer
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jan 6, 2023 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Mayo Clinic
- Interventions being studied
- Biological: Anetumab Ravtansine; Biological: Atezolizumab; Other: Laboratory Biomarker Analysis
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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 =\< 14 days prior to registration
- Platelets \>= 100 ? 10\^9/L =\< 14 days prior to registration
- Hemoglobin \>= 9 g/dL =\< 14 days prior to registration
- Potassium \>= lower limit of normal (LLN) range for the institution =\< 14 days prior to registration
- NOTE: Supplementation may be given before the first dose of study medication
- Calcium \>= LLN (corrected for serum albumin, if albumin abnormal) =\< 14 days prior to registration
- NOTE: Supplementation may be given before the first dose of study medication
- Magnesium \>= LLN =\< 14 days prior to registration
- NOTE: Supplementation may be given before the first dose of study medication
- Sodium \>= LLN =\< 14 days prior to registration
- NOTE: Supplementation may be given before the first dose of study medication
- Phosphorus \>= LLN =\< 14 days prior to registration
- NOTE: Supplementation may be given before the first dose of study medication
- International normalized ratio (INR) =\< 1.5 =\< 14 days prior to registration
- Serum creatinine =\< 1.5 mg/dL or creatinine clearance \>= 50 mL/min (calculated by Cockcroft Gault equation) =\< 14 days prior to registration
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 x ULN or =\< 5 x upper limits of normal (ULN) if liver metastases are present =\< 14 days prior to registration
- Total bilirubin =\< 1.5 x ULN =\< 14 days prior to registration
- Standard 12-lead electrocardiogram (ECG) with the following parameters at screening (defined as the mean of the triplicate ECGs):
- QT corrected by Fridericia's formula (QTcF) interval at screening \< 450msec (using Fridericia?s correction)
- Negative pregnancy test performed =\< 7 days prior to registration (women of childbearing potential only)
- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
- Willing to provide blood samples for correlative research purposes
REGISTRATION ?
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Mayo Clinic HospitalPhoenix, Arizona
- Mayo Clinic in FloridaJacksonville, Florida
- Mayo ClinicRochester, Minnesota
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 6, 2023. Always confirm current availability with the study team.