A Study on Exploring the Abscopal Effect Induced by Different Radioimmunotherapy Combination Patterns in the Treatment of Non-Small Cell Lung Cancer With Multiple Metastases

A Prospective, Multicenter, Umbrella Design Clinical Study on the Abscopal Effect Induced by Different Radioimmunotherapy Combination Patterns in the Treatment of Non-Small Cell Lung Cancer With Multiple Metastases

NCT06947694•Xinqiao Hospital of Chongqing

View on ClinicalTrials.gov

Summary

It is planned to carry out a multicenter umbrella study to find the optimal organ combination and the best radioimmunotherapy combination pattern, so as to improve the survival of NSCLC patients with multiple metastases. At the same time, by using multimodal omics data, machine learning will be employed to construct a prediction model for the abscopal effect, and explore the immunoregulation of organ-specific radiotherapy and biomarkers of the abscopal effect. The main objective is to find the optimal organ combination and the best radioimmunotherapy combination pattern.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Non-small cell lung cancer diagnosed initially through pathological histology.
•2. There are 3-6 metastatic lesions.
•3. No brain metastasis or the lesions are stable.
•4. Negative for driver genes (including EGFR, ALK, ROS, BRAF, MET, RET genes. Note: The above English terms are all gene names).
•5. ECOG (Eastern Cooperative Oncology Group) score: 0-1 point, with an expected, survival period of more than 3 months.
•6. Aged between 18 and 75 years old.
•7. Evaluated by PET-CT (including FDG and FMISO, not mandatory).
•8. No contraindications for immunotherapy and radiotherapy.
•9. The informed consent form has been signed.

Exclusion Criteria

•1. Those with severe dysfunction of vital organs (heart, liver, kidney).
•2. Those accompanied by other malignant tumors.
•3. Those with uncontrolled heart diseases or having experienced a myocardial infarction within the past six months.
•4. Those with a history of mental illness.
•5. And other situations in which the researchers deem it inappropriate for the subjects to participate in the study.

Locations (1)

the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, China

Key Dates

Start Date

July 2, 2025

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2027

Last Updated

July 22, 2025

Enrollment

427

ESTIMATED participants

Conditions

NSCLC Stage IV Without EGFR/ALK Mutation

Interventions