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

Phase 2

Recruiting

• Conditions: NSCLC Stage IV Without EGFR/ALK Mutation
• Interventions: Drug: Benmelstobart combined with chemotherapy; Drug: Benmelstobart combined with Bevacizumab and chemotherapy

• Registration Number: NCT06953843
• Lead Sponsor: Xinqiao Hospital of Chongqing

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-20
• Study First Submitted QC: 2025-04-29
• Study First Posted: 2025-05-01
• Status Verified: 2025-07
• Study Start: 2025-07-09
• Last Update Submitted: 2025-07-11
• Last Update Posted: 2025-07-14
• Primary Completion: 2027-06-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 366

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Benmelstobart combined with chemotherapy	-
Group B	Benmelstobart combined with chemotherapy	-
Group C	Benmelstobart combined with chemotherapy	-
Group D	Benmelstobart combined with chemotherapy	-
Group E	Benmelstobart combined with chemotherapy	-
Group F	Benmelstobart combined with Bevacizumab and chemotherapy	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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	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 progression-free survival rate according to RECIST v1.1
OS	up to 5 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 by overall survival
AE	From date of consent informed until 60 days after the last investigational product administration. Up to approximately 2 years	The incidence of immune-related adverse events (irAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Trial Locations

Locations (1)

the second affiliated hospital of Army medical university; 🇨🇳 Chongqing, Chongqing, China