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A Trial With Chemotherapy, Immunotherapy, and Radiotherapy for Patients With Newly Diagnosed Stage IV Small Cell Lung Cancer

Small-cell Lung Cancer Clinical Trial

Official title:
Phase II Trial of Platinum-Etoposide Chemotherapy and Durvalumab (MEDI4736) With Sub-Ablative SBRT in Patients With Newly Diagnosed Stage IV Small Cell Lung Cancer

Clinical Trial Summary

This study is for subjects with untreated Stage IV small cell lung cancer. Subjects will be given radiation therapy for five days, followed by standard of care chemo-immunotherapy (etoposide + carboplatin or cisplatin + durvalumab) for 4 cycles. Subjects may continue to receive durvalumab after 4 cycles have been completed until disease progression.

Clinical Trial Description

This is a non-randomized, open-label, single-arm pilot phase II study of non-ablative stereotactic body radiotherapy (SBRT) in combination with standard-of-care chemo-immunotherapy in patients with untreated, extensive-stage (Stage IV) small cell lung cancer. Subjects will be treated with etoposide plus platinum (carboplatin or cisplatin) chemotherapy together with the PD-L1 checkpoint inhibitor durvalumab, which is a standard of care in this disease setting. Subjects will also receive a total of 6 Gy of radiotherapy X 5 fractions targeting multiple sites of intrathoracic disease when feasible and starting on the first day of the first cycle of chemo-immunotherapy; no further radiation will be planned after this. The hypothesis of this study is that the addition of sub-ablative doses of radiation to combination chemotherapy and immunotherapy will be safe and feasible and result in improved outcomes for patients with treatment-naive, extensive-stage small cell lung cancer. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04951115
Study type Interventional
Source Weill Medical College of Cornell University
Contact
Status Active, not recruiting
Phase Phase 2
Start date July 12, 2021
Completion date July 1, 2025
View Details
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