CClinicalTrials.gg
Not yet recruitingNCT06154967Updated Dec 4, 2023

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

An interventional study of tereotactic body radiotherapy in Non-Small Cell Lung Cancer Without Mutation in Epidermal Growth Factor Receptor (Disorder), sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-12-04.

Sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Non-Small Cell Lung Cancer Without Mutation in Epidermal Growth Factor Receptor (Disorder)
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University is the lead sponsor of 115 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

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

    Radiation: tereotactic body radiotherapy

Interventions

  • Radiationtereotactic body radiotherapy

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

    Also known as: tislelizumab

06

What researchers measure

Primary outcomes

  1. The Overall Response Rate out of the radiation field

    To evaluate the efficacy of this protocol,Measurements were based on recist1.1

    Time frame: Individual patients should be evaluated within 3 days after the patient follow-up examination

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06154967
Lead sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Responsible party
Xiong Yanli, MD (Associate Medical Director, Oncology, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University) — Principal investigator
First posted
Dec 4, 2023
Start date
Jan 1, 2024 (estimated)
Primary completion
Jun 30, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Dec 4, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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