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Report for Clinical Trial NCT04120454

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

An Investigator-Sponsored Phase 2 Single Arm Trial of Ramucirumab and Pembrolizumab in Patients With EGFR Mutant Non-Small Cell Lung Cancer

This phase II trial studies how well ramucirumab and pembrolizumab work in treating EGFR mutant non-small cell lung cancer that has come back (recurrent) or spread to other places in the body (metastatic). Ramucirumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ramucirumab and pembrolizumab may work better in treating EGFR mutant non-small cell lung cancer compared to pembrolizumab alone.

NCT04120454 Metastatic Lung Non-Small Cell Carcinoma Recurrent Lung Non-Small Cell Carcinoma Stage IV Lung Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8
MeSH:Carcinoma Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Carcinoma Neoplasm of the lung Non-small cell lung carcinoma

2 Interventions

Name: Pembrolizumab

Description: Given IV
Type: Biological
Group Labels: 1

Treatment (ramucirumab, pembrolizumab)

Name: Ramucirumab

Description: Given IV
Type: Biological
Group Labels: 1

Treatment (ramucirumab, pembrolizumab)


Primary Outcomes

Description: Response rate will be evaluated with computed tomography (CT) scans every 2 cycles and tumor measurements using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Immune RECIST (iRECIST) will also be assessed.

Measure: Overall response rate

Time: Up to 2 years

Secondary Outcomes

Description: Common Terminology Criteria for Adverse Events version 4.0 will be used for adverse event grading. Attributions of causality will be assessed by the primary treating physician. Frequency and severity of adverse events and tolerability of the regimen will be collected and summarized by descriptive statistics for each of the disease cohorts.

Measure: Incidence of adverse events

Time: Up to 2 years

Description: Clinical benefit rate will be evaluated with CT scans every 2 cycles and tumor measurements using RECIST 1.1 criteria. iRECIST will also be assessed.

Measure: Clinical benefit rate (complete response + partial response + stable disease)

Time: Up to 2 years

Description: Kaplan-Meier curves will be calculated to estimate progression-free survival.

Measure: Progression-free survival

Time: From the date of study registration to the date of progressive disease, assessed up to 2 years

Description: Kaplan-Meier curves will be calculated to estimate overall survival.

Measure: Overall survival

Time: From the date of study registration to the date of death, assessed up to 2 years

Other Outcomes

Description: Measured by immunohistochemistry, including tumor infiltrating lymphocytes and T cell receptor (TCR) immunosequencing (immunoSEQ) and relationship to clinical outcomes, including response rate. TCR immunoSEQ data will be summarized for each patient for T-cell clonality difference, descriptive statistics and confidence interval will be obtained across patients.

Measure: Tumor immunoprofile

Time: Baseline

Description: Measured using 10-color 65 marker multiplex Clinical Laboratory Improvement Act-certified IMMUNOME flow cytometry profile on peripheral blood samples. For immune cell subpopulation data by flow cytometry, will identify differences between the paired peripheral blood mononuclear cell samples from the same patients.

Measure: Circulating immune cell profiles in response to treatment and in relation to clinical response

Time: Up to 2 years

Description: Will evaluate correlation with clinical response. A bivariate plot will be used to describe the relationship between response rate and peak VEGF via enzyme-linked immunosorbent assay over time.

Measure: Change in circulating VEGF levels

Time: Baseline up to 2 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 T790M

Patients who develop progressive disease after erlotinib, gefitinib, afatinib, or dacomitinib must either receive osimertintib (T790M positive) or be T790M negative. --- T790M ---

Patients who develop progressive disease after erlotinib, gefitinib, afatinib, or dacomitinib must either receive osimertintib (T790M positive) or be T790M negative. --- T790M --- --- T790M ---



HPO Nodes


HPO: