Non-Small Cell Lung Cancer Without Mutation in Epidermal Growth Factor Receptor (Disorder)
Conditions
Brief summary
The goal of this clinical trial is to learn about in describe participant population. The main questions it aims to answer are: the outcomes of the efficacy (ORR) and safety (adverse events, including irAEs, AE, SAEs, and laboratory indicators) of continued immunotherapy in patients with immune-resistant IIIc/IV metastatic NSCLC treated with immune-induced radiotherapy (SBRT). Participants will be asked to accept the treatment of ICIs regimen and SBRT plan as follows: ICIs regimen: tislelizumab 200mg every 3 weeks, the first dose was given 7 days after the last SBRT treatment, then the first day of each cycle, 21 days as a cycle until disease progression. SBRT plan: The radiation dose and fractionation of SBRT should be evaluated according to the size and location of the tumor.
Interventions
RADIATIONtereotactic body radiotherapy
In second-line and later treatment, the treatment regimen of SBRT combined with tislelizumab is used
Sponsors
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with IIIc/IV NSCLC confirmed by histology and imaging 2. Previous treatment with anti-PD1 or anti-PDL1, and resistantance to ICIs 3. Without standard treatment regimen 4. At least one measurable target (primary tumour or metastasis) according to RECIST v1.1 5. Age ≥ 18 and ≤ 75 6. ECOG PS ≤ 2 7. Life expectancy ≥ 3 months
Exclusion criteria
1. Autoimmune disease that might be aggravated during treatment with an immuno-stimulating agent (patients with type I diabetes, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible) 2. Immunosuppressive long-term treatment (patients necessitating a corticotherapy are eligible if they are administered in doses \< or = to the equivalent of 10 mg of prednisone daily, administration of steroids by a route resulting in minimal systemic exposure (local, intra-anal, intraocular or inhalation) are eligible). 3. Transplant patients (including stem cell transplants), HIV positive or other immune deficiency syndromes 4. Active infection by HBV or HCV Known severe hypersensitivity to monoclonal antibodies or history of anaphylactic shock, or uncontrolled asthma 5. Patient with interstitial pneumonitis or pulmonary fibrosis or any other known severe respiratory insufficiency 6. Patient already included in another clinical trial during treatment with an experimental
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Overall Response Rate out of the radiation field | Individual patients should be evaluated within 3 days after the patient follow-up examination | To evaluate the efficacy of this protocol，Measurements were based on recist1.1 |
Outcome results
None listed