Liver Directed RT + Chemo-immunotherapy for ES-SCLC

Status Recruiting

Clinical Trial Summary

The purpose of this study is to evaluate whether radiation treatment directed at liver metastases can be safely added to standard of care treatment for extensive stage small cell lung cancer (ES-SCLC). The current standard treatment for people who have ES-SCLC is chemotherapy including drugs called carboplatin and etoposide, that is combined with a type of immunotherapy called atezolizumab. However, patients with liver involvement of their ES-SCLC don't respond as well to this treatment. The study aims to answer whether adding radiation directed at liver metastases can improve responses to standard chemo-immunotherapy in this patient population. All study participants will get the same study intervention, which will be chemo-immunotherapy and radiation therapy.

Clinical Trial Description

Although the clinical evidence for the combination of radiation therapy and immunotherapy is more limited, numerous case reports, retrospective studies, early stage trials, and ongoing prospective trials highlight the potential for combining radiation with immunotherapy in augmenting the anti-tumor response. The combination of stereotactic body radiation therapy (SBRT) of liver lesions with immunotherapy has been less well studied. Given the findings that patients with ES-SCLC and liver involvement have a poor prognosis and a limited response to chemo-immunotherapy, the investigators aim to augment the systemic anti-tumor immune response with RT targeted to liver metastases administered in addition to standard of care treatment. Preclinical data and prior clinical studies support the reasoning for these treatment approaches, and the investigators hypothesize that combination RT with chemo-immunotherapy will lead to improved local control and progression free survival in ES-SCLC patients with liver involvement. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04923776
Study type	Interventional
Source	Columbia University
Contact	Brian Henick, MD
Phone	212 305 3997
Email	bh2682@cumc.columbia.edu
Status	Recruiting
Phase	Phase 2
Start date	September 20, 2021
Completion date	February 2025

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