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 (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06154967

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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	Intervention/Treatment	Phase
Non-Small Cell Lung Cancer Without Mutation in Epidermal Growth Factor Receptor (Disorder)	Radiation: tereotactic body radiotherapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

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)

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ICIs regimen: tislelizumab 200mg every 3 weeks, the first dose was given 7 days after the last SBRT	Radiation: tereotactic body radiotherapy In second-line and later treatment, the treatment regimen of SBRT combined with tislelizumab is used Other Names: tislelizumab

Arm

Intervention/Treatment

Experimental: ICIs regimen: tislelizumab 200mg every 3 weeks, the first dose was given 7 days after the last SBRT

Radiation: tereotactic body radiotherapy

In second-line and later treatment, the treatment regimen of SBRT combined with tislelizumab is used

Other Names:

tislelizumab

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiong Yanli, MD, Associate Medical Director, Oncology, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

ClinicalTrials.gov Identifier:

NCT06154967

Other Study ID Numbers:

DPCC-20231122

First Posted:

Dec 4, 2023

Last Update Posted:

Dec 4, 2023

Last Verified:

Dec 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Tislelizumab

Study Results

No Results Posted as of Dec 4, 2023