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

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.

Conditions

• NSCLC Stage IV Without EGFR/ALK Mutation

Interventions

DRUG

Benmelstobart 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.

DRUG

Benmelstobart 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.

DRUG

Benmelstobart 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.

DRUG

Benmelstobart 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.

DRUG

Benmelstobart combined with chemotherapy

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

DRUG

Benmelstobart 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.

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing

  lead OTHER

Principal Investigators

• Jianguo Sun, MD · the second affiliated hospital of Army medical university, Chongqing, Chongqing 40037 Recruiting

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-09

Primary Completion

2027-06-30

Completion

2027-12-31

Countries

• China

Study Locations