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NCT06154967 | NOT YET RECRUITING | Non-Small Cell Lung Cancer Without Mutation in Epidermal Growth Factor Receptor (Disorder)

To Explore the Effect of Immune-induced Stereotactic Body Radiotherapy (SBRT) on Reversing Immunoresistance in Stage IIIc/IV Non-small Cell Lung Cancer (NSCLC)
Sponsor:

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Information provided by (Responsible Party):

X ion GY case, MD

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.

Condition or disease

Non-Small Cell Lung Cancer Without Mutation in Epidermal Growth Factor Receptor (Disorder)

Intervention/treatment

tereotactic body radiotherapy

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : To Explore the Effect of Immune-induced Stereotactic Body Radiotherapy (SBRT) on Reversing Immunoresistance in Stage IIIc/IV Non-small Cell Lung Cancer (NSCLC)
Actual Study Start Date : 2024-01-01
Estimated Primary Completion Date : 2025-06-30
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
To Explore the Effect of Immune-induced Stereotactic Body Radiotherapy (SBRT) on Reversing Immunoresistance in Stage IIIc/IV Non-small Cell Lung Cancer (NSCLC)

Location Details

NCT06154967

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