SBRT for Oligo-residual NSCLC After Treatment With PD-1/PD-L1 Immune Checkpoint Inhibitors
An Open-label, Multicenter, Phase II Single Arm Trial of Stereotactic Body Radiotherapy for Oligo-residual Disease After Effective Treatment With PD-1/PD-L1 Inhibitors Among Metastatic Non-small Cell Lung Cancer
Fudan University
59 participants
Jan 1, 2021
INTERVENTIONAL
Conditions
Summary
Despite the impressive response rate to PD-1/PD-L1 immune checkpoint inhibitors, resistance inevitably develops in most patients. Stereotactic body radiation therapy (SBRT) plays a growing role in the management of oligometastatic disease. This study aims to evaluate the efficacy and safety of SBRT for oligo-residual NSCLC after effective treatment with PD-1/PD-L1 inhibitors.
Eligibility
Plain Language Summary
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Interventions
Patients will receive PD-1/PD-L1 inhibitors for up to 2 years or until confirmed progression or unacceptable toxicity. PD-1/PD-L1 inhibitors will be administrated as an intravenous(IV) infusion.
Patients with oligo-residual NSCLC after effective treatment with PD-1/PD-L1 inhibitors will be treated with curative-intent SBRT of residual lesions. The choice of dose-fractionation regimen is at the discretion of the treating radiation oncologist. PD-1/PD-L1 inhibitors will be withheld one day before the treatment and resumed within 2 weeks after completion of SBRT.
Locations(1)
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NCT04767009