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Platinum-Based Chemotherapy Plus Ramucirumab in Patients With Advanced NSCLC Who Have Progressed on First Line Anti-PD-1 Immunotherapy

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:
Phase-II Trial of Platinum-Based Chemotherapy Plus Ramucirumab in Patients With Advanced NSCLC Who Have Progressed on First Line Anti-PD-1 Immunotherapy

Clinical Trial Summary

This is a non-randomized, phase-II study of platinum doublet chemotherapy plus ramucirumab in patients with advanced NSCLC who have progressed on first line anti-PD-1 Immunotherapy. Up to 25 evaluable participants will be enrolled over a period of 2 years. Seven patients will be recruited at the first stage .Eligible patients would include those treated with a PD-1 inhibitor as primary therapy and exhibit evidence of disease progression, but maintain a good performance status. The investigators hypothesize that immune therapy acts as chemo-sensitizer and patients treated with standard platinum-based combination chemotherapy with the addition of the anti-angiogenic agent Ramucirumab, after immunotherapy will have higher response rates

Clinical Trial Description

OBJECTIVES: Primary Objective 1. To assess the objective response rate to a three-drug regimen (a platinum doublet plus an anti-angiogenic agent) in patients with non-small cell lung cancer who fail to respond, or progress after an initial response, to primary therapy with an immune checkpoint inhibitor. 2. To assess the toxicity profile of the three-drug regimen in this population compared to historical treatment-naïve population (as published in literature) Exploratory Objective 1. To investigate the role of peripheral blood CD 8+ T cells, absolute eosinophil count (AEC) and circulating tumor cells (CTC) as biomarkers of response to salvage chemotherapy after primary immunotherapy 2. To investigate the role of plasma carbonic anhydrase IX level as predictive biomarker of response to ramucirumab. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03904108
Study type Interventional
Source Stony Brook University
Contact
Status Terminated
Phase Phase 2
Start date June 27, 2019
Completion date July 27, 2020
View Details
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