Ramucirumab and Pembrolizumab for the Treatment of EGFR Mutant Recurrent or Metastatic Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT04120454|
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|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||Biological: Pembrolizumab Biological: Ramucirumab||Phase 2|
I. To evaluate response rate of the combination of ramucirumab and pembrolizumab in EGFR mutant non-small cell lung cancer (NSCLC).
I. To evaluate safety, tolerability, and survival for patients receiving pembrolizumab and ramucirumab.
I. To characterize predictive immunologic biomarkers of response in tissue and peripheral blood of patients receiving ramucirumab and pembrolizumab combination therapy.
Patients receive ramucirumab intravenously (IV) over 60 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, every 3 months for 1 year, and then every 6 months for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Investigator-Sponsored Phase 2 Single Arm Trial of Ramucirumab and Pembrolizumab in Patients With EGFR Mutant Non-Small Cell Lung Cancer|
|Actual Study Start Date :||March 16, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Treatment (ramucirumab, pembrolizumab)
Patients receive ramucirumab IV over 60 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
- Overall response rate [ Time Frame: Up to 2 years ]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.
- Incidence of adverse events [ Time Frame: Up to 2 years ]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.
- Clinical benefit rate (complete response + partial response + stable disease) [ Time Frame: Up to 2 years ]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.
- Progression-free survival [ Time Frame: From the date of study registration to the date of progressive disease, assessed up to 2 years ]Kaplan-Meier curves will be calculated to estimate progression-free survival.
- Overall survival [ Time Frame: From the date of study registration to the date of death, assessed up to 2 years ]Kaplan-Meier curves will be calculated to estimate overall survival.
- Tumor immunoprofile [ Time Frame: Baseline ]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.
- Circulating immune cell profiles in response to treatment and in relation to clinical response [ Time Frame: Up to 2 years ]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.
- Change in circulating VEGF levels [ Time Frame: Baseline up to 2 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04120454
|Contact: The Ohio State University Comprehensive Cancer Center||1-800-293-5066||OSUCCCClinicaltrial@osumc.edu|
|Contact: Carly Pilcherfirstname.lastname@example.org|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Erin M. Bertino, MD 614-293-8000 Erin.Bertino@osumc.edu|
|Principal Investigator: Erin M. Bertino, MD|
|Principal Investigator:||Erin M Bertino, M.D.||Ohio State University Comprehensive Cancer Center|