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
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 427
- Locations
- 1
- Primary Endpoint
- The remission rate of abscopal lesions
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient must meet all of the following inclusion criteria to be enrolled in this study:
- •Non-small cell lung cancer diagnosed initially through pathological histology.
- •There are 3-6 metastatic lesions.
- •No brain metastasis or the lesions are stable.
- •Negative for driver genes (including EGFR, ALK, ROS, BRAF, MET, RET genes. Note: The above English terms are all gene names).
- •ECOG (Eastern Cooperative Oncology Group) score: 0-1 point, with an expected, survival period of more than 3 months.
- •Aged between 18 and 75 years old.
- •Evaluated by PET-CT (including FDG and FMISO, not mandatory).
- •No contraindications for immunotherapy and radiotherapy.
- •The informed consent form has been signed.
Exclusion Criteria
- •Patients with any of the following criteria are not eligible for enrollment in this study:
- •Those with severe dysfunction of vital organs (heart, liver, kidney).
- •Those accompanied by other malignant tumors.
- •Those with uncontrolled heart diseases or having experienced a myocardial infarction within the past six months.
- •Those with a history of mental illness.
- •And other situations in which the researchers deem it inappropriate for the subjects to participate in the study.
Arms & Interventions
Group A
Intervention: chemotherapy + PD-1 inhibitors (Drug)
Group B
Intervention: chemotherapy + PD-1 inhibitors (Drug)
Group C
Intervention: chemotherapy + PD-1 inhibitors (Drug)
Group D
Intervention: chemotherapy + PD-1 inhibitors (Drug)
Group E
Intervention: chemotherapy + PD-1 inhibitors (Drug)
Group F
Intervention: chemotherapy + PD-1 inhibitors (Drug)
Group G
Intervention: chemotherapy + PD-1 inhibitors (Drug)
Outcomes
Primary Outcomes
The remission rate of abscopal lesions
Time Frame: 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
The remission rate of abscopal lesions. Immunotherapy is administered within less than 1 week after the start of radiotherapy. The time point for determining the abscopal effect is set as ≤ 4 cycles of immunotherapy. The assessment is carried out in accordance with the RECIST 1.1 (Appendix 1) and iPERCIST criteria.
Secondary Outcomes
- QoF(up to 2 years)
- PFS(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)
- OS(up to 5 years)
- ORR(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)
- DOR(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)
- irAE(From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years)
Investigators
Jianguo Sun
prof
Xinqiao Hospital of Chongqing