To Explore the Effect of Immune-induced Stereotactic Body... | NCT06154967

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

NCT06154967

Sponsor

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

Status

Unknown status

Last Update Posted

Dec 4, 2023Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

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

Interventions

tereotactic body radiotherapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Estimated

Primary Completion Date

Jun 30, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Nov 23, 2023

First Submission Date that Met QC Criteria

Dec 1, 2023

First Posted Date

Dec 4, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2023

Last Update Posted Date

Dec 4, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ICIs regimen: tislelizumab 200mg every 3 weeks, the first dose was given 7 days after the last SBRT	Experimental		Radiation: tereotactic body radiotherapy

Interventions

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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided