Non-Small Cell Lung Cancer Without Mutation in Epidermal Growth Factor Receptor (Disorder)NCT06154967
To Explore the Effect of Immune-induced Stereotactic Body Radiotherapy (SBRT) on Reversing Immunoresistance in Stage IIIc/IV Non-small Cell Lung Cancer (NSCLC)
A study testing tereotactic body radiotherapy in people with Non-Small Cell Lung Cancer Without Mutation in Epidermal Growth Factor Receptor (Disorder), run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer Without Mutation in Epidermal Growth Factor Receptor (Disorder)
- What is being tested?
- tereotactic body radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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).
Read more
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)
- Being tested
- tereotactic body radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tereotactic body radiotherapyRadiation
Also called tislelizumab
In second-line and later treatment, the treatment regimen of SBRT combined with tislelizumab is used
| Study group | Role | What they receive |
|---|---|---|
| ICIs regimen: tislelizumab 200mg every 3 weeks, the first dose was given 7 days after the last SBRT | Experimental | Not described Receives: Radiation: tereotactic body radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Overall Response Rate out of the radiation field
To evaluate the efficacy of this protocol，Measurements were based on recist1.1
Measured: Individual patients should be evaluated within 3 days after the patient follow-up examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer Without Mutation in Epidermal Growth Factor Receptor (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiong Yanli, MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154967
- Sponsor's protocol ID
- DPCC-20231122
- Status last verified
- Dec 2023
- First submitted
- 23 Nov 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06154967
- Acronym / sponsor ID
- DPCC-20231122
- Conditions
- Non-Small Cell Lung Cancer Without Mutation in Epidermal Growth Factor Receptor (Disorder)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICIs regimen: tislelizumab 200mg every 3 weeks, the first dose was given 7 days after the last SBRT | Experimental | Radiation: tereotactic body radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tereotactic body radiotherapyAlso: tislelizumabIn second-line and later treatment, the treatment regimen of SBRT combined with tislelizumab is used | Radiation | ICIs regimen: tislelizumab 200mg every 3 weeks, the first dose was given 7 days after the last SBRT |
Primary outcome
The Overall Response Rate out of the radiation field
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing tereotactic body radiotherapy in people with Non-Small Cell Lung Cancer Without Mutation in Epidermal Growth Factor Receptor (Disorder), run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Overall Response Rate out of the radiation field (time frame: Individual patients should be evaluated within 3 days after the patient follow-up examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.