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

NCT06953843 · tracked via the Priya Life Science China tracker

Sponsor

Xinqiao Hospital of Chongqing

Phase

Phase 2

Started

2025-07-09

Last updated

2025-07-14

Condition(s) studied

NSCLC Stage IV Without EGFR/ALK Mutation

Investigational drug(s) / intervention(s)

Benmelstobart combined with chemotherapy →Benmelstobart combined with chemotherapy →Benmelstobart combined with chemotherapy →Benmelstobart combined with chemotherapy →Benmelstobart combined with chemotherapy →Benmelstobart combined with Bevacizumab and chemotherapy →

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.

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.

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.

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.

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

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.

Study 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

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Patient must meet all of the following inclusion criteria to be enrolled in this study: 1. Non-small cell lung cancer confirmed by pathological histology. 2. More than 3 metastatic lesions. 3. No brain metastases or stable lesions. 4. Negative for driver genes (including EGFR, ALK, ROS, BRAF, MET, RET). 5. Performance status (PS) score of 0-1, with an expected survival period of more than 3 months. 6. Age between 18 and 75 years old. 7. Assessment by PET-CT (including FDG and FMISO, not mandatory). 8. No contraindications to immunotherapy and radiotherapy. 9. Signed the informed consent form. Exclusion Criteria: * Patients with any of the following criteria are not eligible for enrollment in this study: 1. Those with severe dysfunction of important vital organs (heart, liver, kidney). 2. Those accompanied by other malignant tumors. 3. Uncontrolled heart diseases or myocardial infarction within the past 6 months. 4. Those with a history of mental illness. 5. Other situations in which the researcher deems it inappropriate for the subject to participate in the study.

Primary outcome measure(s)

The remission rate of abscopal lesions — From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to approximately 2 years
To evaluate the efficacy of Benmelstobart plus different radiotherapy fractionation modes in non-small cell lung cancer (NSCLC) patients with multiple metastases, as measured by the remission rate of abscopal lesions according to RECIST v1.1

Trial sites (1)

Facility	City	Region	Status
the second affiliated hospital of Army medical university	Chongqing	Chongqing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06953843 on ClinicalTrials.gov ↗ ← All trials in China