Clinical trial NCT06947694: 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: NSCLC Stage IV Without EGFR/ALK Mutation
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 427
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The remission rate of abscopal lesions
timeFrame: 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 2 approximately years
Secondary outcomes:
measure: PFS
timeFrame: 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 2 approximately years
measure: OS
timeFrame: up to 5 years
measure: ORR
timeFrame: 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 2 approximately years
measure: DOR
timeFrame: 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 2 approximately years
measure: irAE
timeFrame: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years
measure: QoF
timeFrame: up to 2 years
Other outcomes:
Locations:
Study officials:
affiliation: the second affiliated hospital of Army medical university, Chongqing, Chongqing 40037 Recruiting
name: Jianguo Sun, MD
role: PRINCIPAL_INVESTIGATOR
References: