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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-Small Cell Lung Cancer Without Mutation in Epidermal Growth Factor Receptor (Disorder)
• Intervention / Treatment: Radiation: tereotactic body radiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Overall Response Rate out of the radiation field	To evaluate the efficacy of this protocol，Measurements were based on recist1.1	Individual patients should be evaluated within 3 days after the patient follow-up examination

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 23, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Actual): December 4, 2023

Study Record Updates

• Last Update Posted (Actual): December 4, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents; Antineoplastic Agents, Immunological; Tislelizumab
• Other Study ID Numbers: DPCC-20231122

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No