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

NCT ID: NCT06154967

Last Updated: 2023-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-12-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

tereotactic body radiotherapy

Intervention Type: RADIATION

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

Interventions

tereotactic body radiotherapy

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

Intervention Type: RADIATION

Other Intervention Names

tislelizumab

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Xiong Yanli, MD

Associate Medical Director, Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

DPCC-20231122

Identifier Type: -

Identifier Source: org_study_id