Status:
UNKNOWN
To Explore the Effect of Immune-induced Stereotactic Body Radiotherapy (SBRT) on Reversing Immunoresistance in Stage IIIc/IV Non-small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Conditions:
Non-Small Cell Lung Cancer Without Mutation in Epidermal Growth Factor Receptor (Disorder)
Eligibility:
All Genders
18-75 years
Phase:
NA
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, includin...
Eligibility Criteria
Inclusion
- Patients with IIIc/IV NSCLC confirmed by histology and imaging
- Previous treatment with anti-PD1 or anti-PDL1, and resistantance to ICIs
- Without standard treatment regimen
- At least one measurable target (primary tumour or metastasis) according to RECIST v1.1
- Age ≥ 18 and ≤ 75
- ECOG PS ≤ 2
- Life expectancy ≥ 3 months
Exclusion
- 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)
- 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).
- Transplant patients (including stem cell transplants), HIV positive or other immune deficiency syndromes
- Active infection by HBV or HCV Known severe hypersensitivity to monoclonal antibodies or history of anaphylactic shock, or uncontrolled asthma
- Patient with interstitial pneumonitis or pulmonary fibrosis or any other known severe respiratory insufficiency
- Patient already included in another clinical trial during treatment with an experimental
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06154967
Start Date
January 1 2024
End Date
December 31 2025
Last Update
December 4 2023
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