RecruitingNCT05486650

An Observational Clinical Study of Stereotactic Radiotherapy for Advanced Non-Small Cell Lung Cancer With Stable Disease After PD-1 Inhibitor Treatment

An Observational Clinical Study of Increasing Stereotactic Radiotherapy in Patients With Advanced Non-small Cell Lung Cancer After Treatment With PD-1 Inhibitors And Evaluation of Stable Disease


Sponsor

Xinqiao Hospital of Chongqing

Enrollment

20 participants

Start Date

Aug 1, 2022

Study Type

OBSERVATIONAL

Summary

After the treatment of advanced non-small cell lung cancer with immune checkpoint inhibitor PD-1/PD-L1 monoclonal antibody, if the treatment response of complete response (CR) or partial response (PR) can be achieved in the early stage, the patients are expected to obtain a better long-term survival rate. Radiotherapy can synergistically improve the effect of immunotherapy. Therefore, we propose a hypothesis: in patients with advanced lung cancer, if only stable disease (SD) is achieved after PD-1 antibody immunotherapy in the early stage, by increasing the stereotactic radiotherapy (SBRT) for primary or metastatic lesions, in order to improve the mechanism of tumor antigen release, promote the activation and activation of effector T cells, and increase the sensitivity of immunotherapy, so as to achieve the goal of early improvement of objective remission rate (ORR). It is expected to improve the long-term survival rate of patients.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether stereotactic body radiation therapy (SBRT) — a highly precise form of radiation that delivers large doses over a few sessions — can help control advanced non-small cell lung cancer (NSCLC) in patients whose disease has stabilized ('stable disease') after initial immunotherapy. **You may be eligible if...** - You are 18 or older - You have Stage IIIB, IIIC, or IV non-small cell lung cancer confirmed by biopsy - You received 3–4 cycles of a PD-1 immunotherapy drug (with or without chemotherapy) and your cancer showed stable disease (not growing, not responding dramatically) - Your cancer does not have EGFR, ALK, or ROS1 mutations - You have measurable disease and good general health (ECOG 0–1) - You have good heart and lung function **You may NOT be eligible if...** - Your tumor has known driver gene mutations (EGFR, ALK, or ROS1 positive) - You have serious liver or kidney problems - You had serious side effects during your prior immunotherapy - You have been on steroids or immune-suppressing drugs recently 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 inhibitor

After receiving PD-1 inhibitor treatment in the first three cycles, patients with locally advanced or advanced NSCLC whose curative effect is evaluated as stable disease receive SBRT combined with PD-1 inhibitor treatment


Locations(1)

the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, China

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NCT05486650