Clinical trial NCT06953843: 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
Official title: An Umbrella Trial of Combining Different Radiotherapy Fractionation Patterns With Immunotherapy for Multiple Metastases of Non-Small Cell Lung Cancer
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: 2025-05-01
Enrollment: 366
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: 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.


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 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.

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 approximately 2 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 approximately 2 years
measure: OS
timeFrame: up to 5 years
measure: AE
timeFrame: From date of consent informed until 60 days after the last investigational product administration. Up to approximately 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: