RecruitingPhase 2NCT04767009

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


Sponsor

Fudan University

Enrollment

59 participants

Start Date

Jan 1, 2021

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing stereotactic body radiation therapy (SBRT) — a precise, high-dose radiation technique — for patients with stage IV non-small cell lung cancer who still have a small number of remaining tumor sites after responding to immunotherapy (PD-1/PD-L1 checkpoint inhibitors). **You may be eligible if...** - You are 18 years or older and in reasonably good health (ECOG PS 0–1) - You have confirmed stage IV NSCLC without EGFR, ALK, or ROS-1 driver mutations - You had a good response to PD-1/PD-L1 immunotherapy but have a few remaining tumor sites amenable to SBRT - Any brain metastases must be stable and not requiring steroids **You may NOT be eligible if...** - Your tumor has EGFR, ALK, or ROS-1 mutations - You did not respond well to immunotherapy - You have too many remaining tumor sites for SBRT Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPD-1/PD-L1 inhibitors (alone or in combination with chemotherapy)

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.

RADIATIONSBRT

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)

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT04767009


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