RecruitingPhase 2NCT06953843

Study on the Optimal Combination Pattern of the Combined Treatment of Radiotherapy and Immunotherapy for the Abscopal Effect in Non-Small Cell Lung Cancer (NSCLC) With Multiple Metastases

An Umbrella Trial of Combining Different Radiotherapy Fractionation Patterns With Immunotherapy for Multiple Metastases of Non-Small Cell Lung Cancer


Sponsor

Xinqiao Hospital of Chongqing

Enrollment

366 participants

Start Date

Jul 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to conduct a prospective, multicenter, umbrella clinical study to compare the abscopal effects of different radiotherapy fractionation patterns combined with Benmelstobart, and to explore an efficient and low-toxic treatment strategy for non-small cell lung cancer (NSCLC) with multiple metastases. The main objective is to explore and compare the control rates of abscopal lesions in NSCLC patients with multiple metastases when different radiotherapy fractionation patterns are combined with Benmelstobart.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing different combinations of immunotherapy and targeted radiation for people with advanced non-small cell lung cancer (NSCLC) that has spread to multiple parts of the body. Researchers want to find the best way to combine these treatments to improve outcomes. **You may be eligible if...** - You are between 18 and 75 years old with confirmed non-small cell lung cancer - Your cancer has spread to more than 3 areas in the body - Your cancer does not have any of the common gene mutations (EGFR, ALK, ROS, BRAF, MET, RET) - You have no brain metastases, or any that are already stable - You are in generally good health (able to perform daily activities) **You may NOT be eligible if...** - You have severe organ problems (heart, liver, or kidney) - You have another active cancer - You have had a heart attack or uncontrolled heart disease in the past 6 months - You have a psychiatric condition or history of mental illness 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

DRUGBenmelstobart combined with chemotherapy

After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression, the patient will receive the treatment of 6-10Gy\*3-6F plus Benmelstobart.

DRUGBenmelstobart combined with chemotherapy

After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression and the largest lesion measures between 3 cm and 5 cm, the patient will receive the treatment of 3 Gy \* 15 fractions plus Benmelstobart.

DRUGBenmelstobart combined with chemotherapy

After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression and the largest lesion is larger than 5 cm, the patient will receive treatment with Spatial Fractionated Radiotherapy Technique (SFRT) plus Benmelstobart.

DRUGBenmelstobart combined with chemotherapy

After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression, and when the largest lesion is ≤ 3 cm and the patient can maintain the radiotherapy position for 50 minutes, the patient will receive treatment with the hyperfractionated pulsed radiotherapy technique (0.5 Gy \* 16 \* 6 fractions) plus Benmelstobart.

DRUGBenmelstobart combined with chemotherapy

After 4 cycles of treatment with Benmelstobart combined with chemotherapy, Benmelstobart is continued for maintenance treatment.

DRUGBenmelstobart combined with Bevacizumab and chemotherapy

For eligible subjects who have developed resistance to EGFR-TKI, after 4 cycles of treatment with Benmelstobart combined with Bevacizumab and chemotherapy, if there is no disease progression, they will receive the treatment of 6-10Gy \* 3-6 fractions plus Benmelstobart.


Locations(1)

the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, China

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NCT06953843


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