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Report for Clinical Trial NCT03455556

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase I/II Study of the Human Anti-Mesothelin Antibody Drug Conjugate Anetumab Ravtansine (AR), Combined With the PD-L1 Inhibitor Atezolizumab in 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.

NCT03455556 Mesothelin Positive Stage III Non-Small Cell Lung Cancer AJCC v7 Stage IIIA Non-Small Cell Lung Cancer AJCC v7 Stage IIIB Non-Small Cell Lung Cancer AJCC v7 Stage IV Non-Small Cell Lung Cancer AJCC v7
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

3 Interventions

Name: Anetumab Ravtansine

Description: Given IV
Type: Biological
Group Labels: 1

Treatment (anetumab ravtansine, atezolizumab)

Name: Atezolizumab

Description: Given IV
Type: Biological
Group Labels: 1

Treatment (anetumab ravtansine, atezolizumab)

Name: Laboratory Biomarker Analysis

Description: Correlative studies
Type: Other
Group Labels: 1

Treatment (anetumab ravtansine, atezolizumab)


Primary Outcomes

Description: Maximum tolerated dose (MTD) of anetumab ravtansine combined with atezolizumab defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients) (Phase I)

Measure: Maximum Tolerated Dose (MTD) (Phase I)

Time: Up to 21 days

Description: Defined as a patient who has achieved a partial response (PR) or complete response (CR) on two consecutive evaluations at least 4 weeks apart. Will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated.

Measure: Rate of Confirmed Response (Phase II)

Time: 6 months

Secondary Outcomes

Description: Will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in this patient population.

Measure: Clinical Activity (Phase I)

Time: Up to 6 months

Description: The number and severity of all adverse events (overall and by dose-level) will be tabulated and summarized in this patient population.

Measure: Incidence of Adverse Events According to Common Terminology Criteria for Adverse Events Version 4.0 (Phase I)

Time: Up to 21 days after last dose

Description: Defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier.

Measure: Overall Survival (Phase II)

Time: Up to 2 years

Description: Defined as the time from registration to the earliest date of documentation of disease progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan Meier. Will also report the 1-year progression free survival (PFS) rate for the combination of anetumab ravtansine and atezolizumab in 2nd-line non-small cell lung cancer (NSCLC).

Measure: Progression-free Survival (Phase II)

Time: 1 year and up to 2 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 V600E

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 ? --- V600E ---



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