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NCT06947694 | NOT YET RECRUITING | NSCLC Stage IV Without EGFR/ALK Mutation

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
Sponsor:

Xinqiao Hospital of Chongqing

Information provided by (Responsible Party):

Jiang UO sun

Brief Summary:

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.

Condition or disease

NSCLC Stage IV Without EGFR/ALK Mutation

Intervention/treatment

chemotherapy + PD-1 inhibitors

chemotherapy + PD-1 inhibitors

chemotherapy + PD-1 inhibitors

chemotherapy + PD-1 inhibitors

chemotherapy + PD-1 inhibitors

chemotherapy + PD-1 inhibitors

chemotherapy + PD-1 inhibitors

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 427 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Prospective, Multicenter, Umbrella Design Clinical Study on the Abscopal Effect Induced by Different Radioimmunotherapy Combination Patterns in the Treatment of Non-Small Cell Lung Cancer With Multiple Metastases
Actual Study Start Date : 2025-05-20
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2027-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
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

Location Details

NCT06947694

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