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

Army Medical University of People's Liberation Army

Status and phase: Enrolling; Phase 2

Conditions: NSCLC Stage IV Without EGFR/ALK Mutation

Treatments: Drug: Benmelstobart combined with Bevacizumab and chemotherapy; Drug: Benmelstobart combined with chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06953843

XQonc-023

Details and patient eligibility

About

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.

Enrollment: 366 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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366 participants in 6 patient groups

Group A

Experimental group

Treatment:

Drug: Benmelstobart combined with chemotherapy

Drug: Benmelstobart combined with chemotherapy

Drug: Benmelstobart combined with chemotherapy

Drug: Benmelstobart combined with chemotherapy

Drug: Benmelstobart combined with chemotherapy

Group B

Experimental group

Treatment:

Drug: Benmelstobart combined with chemotherapy

Drug: Benmelstobart combined with chemotherapy

Drug: Benmelstobart combined with chemotherapy

Drug: Benmelstobart combined with chemotherapy

Drug: Benmelstobart combined with chemotherapy

Group C

Experimental group

Treatment:

Drug: Benmelstobart combined with chemotherapy

Drug: Benmelstobart combined with chemotherapy

Drug: Benmelstobart combined with chemotherapy

Drug: Benmelstobart combined with chemotherapy

Drug: Benmelstobart combined with chemotherapy

Group D

Experimental group

Treatment:

Drug: Benmelstobart combined with chemotherapy

Drug: Benmelstobart combined with chemotherapy

Drug: Benmelstobart combined with chemotherapy

Drug: Benmelstobart combined with chemotherapy

Drug: Benmelstobart combined with chemotherapy

Group E

Experimental group

Treatment:

Drug: Benmelstobart combined with chemotherapy

Drug: Benmelstobart combined with chemotherapy

Drug: Benmelstobart combined with chemotherapy

Drug: Benmelstobart combined with chemotherapy

Drug: Benmelstobart combined with chemotherapy

Group F

Experimental group

Treatment:

Drug: Benmelstobart combined with Bevacizumab and chemotherapy