A Study on Exploring the Abscopal Effect Induced by Different Radioimmunotherapy Combination Patterns in the Treatment of Non-Small Cell Lung Cancer 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: chemotherapy + PD-1 inhibitors

Study type: Interventional

Funder types: Other

Identifiers

NCT06947694

XQonc-024

Details and patient eligibility

About

It is planned to carry out a multicenter umbrella study to find the optimal organ combination and the best radioimmunotherapy combination pattern, so as to improve the survival of NSCLC patients with multiple metastases. At the same time, by using multimodal omics data, machine learning will be employed to construct a prediction model for the abscopal effect, and explore the immunoregulation of organ-specific radiotherapy and biomarkers of the abscopal effect. The main objective is to find the optimal organ combination and the best radioimmunotherapy combination pattern.

Enrollment: 427 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 diagnosed initially through pathological histology.
  2. There are 3-6 metastatic lesions.
  3. No brain metastasis or the lesions are stable.
  4. Negative for driver genes (including EGFR, ALK, ROS, BRAF, MET, RET genes. Note: The above English terms are all gene names).
  5. ECOG (Eastern Cooperative Oncology Group) score: 0-1 point, with an expected, survival period of more than 3 months.
  6. Aged between 18 and 75 years old.
  7. Evaluated by PET-CT (including FDG and FMISO, not mandatory).
  8. No contraindications for immunotherapy and radiotherapy.
  9. The informed consent form has been signed.

Exclusion criteria

• Patients with any of the following criteria are not eligible for enrollment in this study:

  1. Those with severe dysfunction of vital organs (heart, liver, kidney).
  2. Those accompanied by other malignant tumors.
  3. Those with uncontrolled heart diseases or having experienced a myocardial infarction within the past six months.
  4. Those with a history of mental illness.
  5. And other situations in which the researchers deem it inappropriate for the subjects 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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427 participants in 7 patient groups

Group A

Experimental group

Treatment:

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Group B

Experimental group

Treatment:

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Group C

Experimental group

Treatment:

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Group D

Experimental group

Treatment:

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Group E

Experimental group

Treatment:

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Group F

Experimental group

Treatment:

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Group G

Experimental group

Treatment:

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors

Drug: chemotherapy + PD-1 inhibitors