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 | Recruiting Phase 2

• 1 other identifier: XQonc-023
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The remission rate of abscopal lesions

  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

  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

Secondary Outcomes (3)

• PFS

  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

• OS

  up to 5 years

• AE

  From date of consent informed until 60 days after the last investigational product administration. Up to approximately 2 years

Study Arms (6)

Group A

EXPERIMENTAL

Drug: Benmelstobart combined with chemotherapy

Group B

EXPERIMENTAL

Drug: Benmelstobart combined with chemotherapy

Group C

EXPERIMENTAL

Drug: Benmelstobart combined with chemotherapy

Group D

EXPERIMENTAL

Drug: Benmelstobart combined with chemotherapy

Group E

EXPERIMENTAL

Drug: Benmelstobart combined with chemotherapy

Group F

EXPERIMENTAL

Drug: Benmelstobart combined with Bevacizumab and chemotherapy

Interventions

Benmelstobart combined with chemotherapy DRUG

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.

Also known as: Radiotherapy

Group A

Benmelstobart combined with Bevacizumab and chemotherapy DRUG

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.

Also known as: Radiotherapy

Group F

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-small cell lung cancer confirmed by pathological histology.
• More than 3 metastatic lesions.
• No brain metastases or stable lesions.
• Negative for driver genes (including EGFR, ALK, ROS, BRAF, MET, RET).
• Performance status (PS) score of 0-1, with an expected survival period of more than 3 months.
• Age between 18 and 75 years old.
• Assessment by PET-CT (including FDG and FMISO, not mandatory).
• No contraindications to immunotherapy and radiotherapy.
• Signed the informed consent form.

You may not qualify if:

• Patients with any of the following criteria are not eligible for enrollment in this study:
• Those with severe dysfunction of important vital organs (heart, liver, kidney).
• Those accompanied by other malignant tumors.
• Uncontrolled heart diseases or myocardial infarction within the past 6 months.
• Those with a history of mental illness.
• Other situations in which the researcher deems it inappropriate for the subject to participate in the study.

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing: lead

Study Sites (1)

the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, 400037, China

RECRUITING

MeSH Terms

Interventions

Drug Therapy; Radiotherapy; Bevacizumab

Intervention Hierarchy (Ancestors)

Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jianguo Sun, MD

  the second affiliated hospital of Army medical university, Chongqing, Chongqing 40037 Recruiting

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianguo Sun, MD

CONTACT

86-13983155736; sunjg09@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: May 1, 2025
• Study Start: July 9, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)