Non Small Cell Lung CancerNCT05486650
An Observational Clinical Study of Stereotactic Radiotherapy for Advanced Non-Small Cell Lung Cancer With Stable Disease After PD-1 Inhibitor Treatment
An observational study of Non Small Cell Lung Cancer, run by Xinqiao Hospital of Chongqing at 1 site in China.
Trial summary
After the treatment of advanced non-small cell lung cancer with immune checkpoint inhibitor PD-1/PD-L1 monoclonal antibody, if the treatment response of complete response (CR) or partial response (PR) can be achieved in the early stage, the patients are expected to obtain a better long-term survival rate. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- PD-1 inhibitor
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with stage IIIB, IIIC and stage IV NSCLC (according to the definition of the 8th edition of the American Joint Commission on cancer), who have not been treated and cannot receive radical surgery or radiotherapy confirmed by histopathology, received 3-4 cycles of PD1 antibody ± chemotherapy in the early stage, and the efficacy was evaluated as stable disease
Who may be able to join
- Informed consent has been signed, and according to the judgment of the investigator, the patient can comply with the study protocol;
- Patients with stage IIIB, IIIC and stage IV NSCLC (according to the definition of the 8th edition of the American Joint Commission on cancer), who have not been treated and cannot receive radical surgery or radiotherapy confirmed by histopathology, received 3-4 cycles of PD1 antibody ± chemotherapy in the early stage, and the efficacy was evaluated as SD;
- Previously, no EGFR sensitive mutation and ALK, ROS1 gene fusion mutation were detected based on tissue examination;
- There are measurable lesions evaluated by researchers according to RECIST version 1.1;
- The physical state score (ECOG PS) of the eastern cancer cooperation group was 0-1;
- Good cardiopulmonary function
Who cannot join
- The patient's compliance is poor and violates the test regulations;
- Patients with positive driver gene are known to carry EGFR mutation or ALK, ROS1 gene translocation;
- There are dysfunction of important organs of liver and kidney, such as myocardial infarction, angina pectoris, liver transaminase significantly increased;
- Serious adverse drug reactions occurred during induction;
- Have suffered from any disease requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days before enrollment;
- Severe infection occurred within 4 weeks before enrollment, including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia;
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- Severe chronic or active infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibiotic treatment within 14 days before enrollment;
- Have a history of interstitial lung disease, non infectious pneumonia or poorly controlled diseases, including pulmonary fibrosis, acute lung disease, etc;
- Untreated patients with chronic hepatitis B, HBV carriers with hepatitis B virus (HBV) DNA ≥ 500 iu/ml, or patients with active hepatitis C virus (HCV) should be excluded;
- Known history of HIV infection;
- Received any other trial drug treatment or participated in other clinical trials within 28 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the second affiliated hospital of Army medical university
Chongqing, Chongqing Municipality, 40037
jianguo sun, Phd, 023-68774490, sunjg09@aliyun.com
About this study
Official title: An Observational Clinical Study of Increasing Stereotactic Radiotherapy in Patients With Advanced Non-small Cell Lung Cancer After Treatment With PD-1 Inhibitors And Evaluation of Stable Disease
After the treatment of advanced non-small cell lung cancer with immune checkpoint inhibitor PD-1/PD-L1 monoclonal antibody, if the treatment response of complete response (CR) or partial response (PR) can be achieved in the early stage, the patients are expected to obtain a better long-term survival rate. Radiotherapy can synergistically improve the effect of immunotherapy. Therefore, we propose a hypothesis: in patients with advanced lung cancer, if only stable disease (SD) is achieved after PD-1 antibody immunotherapy in the early stage, by increasing the stereotactic radiotherapy (SBRT) for primary or metastatic lesions, in order to improve the mechanism of tumor antigen release, promote the activation and activation of effector T cells, and increase the sensitivity of immunotherapy, so as to achieve the goal of early improvement of objective remission rate (ORR). It is expected to improve the long-term survival rate of patients.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- PD-1 inhibitor
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 inhibitorDrug
Also called Stereotactic Body Radiation Therapy
After receiving PD-1 inhibitor treatment in the first three cycles, patients with locally advanced or advanced NSCLC whose curative effect is evaluated as stable disease receive SBRT combined with PD-1 inhibitor treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
The proportion of patients whose tumors shrink to a certain amount and remain for a certain period of time, including cases of complete response and partial response.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start1 Aug 2022
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2026 (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 CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianguo Sun, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486650
- Sponsor's protocol ID
- 2021-yandi147-01
- Status last verified
- Jul 2025
- First submitted
- 1 Aug 2022
- Last updated
- 14 Jul 2025
- 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 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Clinical Study of Increasing Stereotactic Radiotherapy in Patients With Advanced Non-small Cell Lung Cancer After Treatment With PD-1 Inhibitors And Evaluation of Stable Disease
- ClinicalTrials.gov ID
- NCT05486650
- Acronym / sponsor ID
- 2021-yandi147-01
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 3 Aug 2022 (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.
After the treatment of advanced non-small cell lung cancer with immune checkpoint inhibitor PD-1/PD-L1 monoclonal antibody, if the treatment response of complete response (CR) or partial response (PR) can be achieved in the early stage, the patients are expected to obtain a better long-term survival rate. Radiotherapy can synergistically improve the effect of immunotherapy. Therefore, we propose a hypothesis: in patients with advanced lung cancer, if only stable disease (SD) is achieved after PD-1 antibody immunotherapy in the early stage, by increasing the stereotactic radiotherapy (SBRT) for primary or metastatic lesions, in order to improve the mechanism of tumor antigen release, promote the activation and activation of effector T cells, and increase the sensitivity of immunotherapy, so as to achieve the goal of early improvement of objective remission rate (ORR). It is expected to improve the long-term survival rate of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage IIIB, IIIC and stage IV NSCLC (according to the definition of the 8th edition of the American Joint Commission on cancer), who have not been treated and cannot receive radical surgery or radiotherapy confirmed by histopathology, received 3-4 cycles of PD1 antibody ± chemotherapy in the early stage, and the efficacy was evaluated as stable disease
Key inclusion criteria (6 listed)
- Informed consent has been signed, and according to the judgment of the investigator, the patient can comply with the study protocol;
- Patients with stage IIIB, IIIC and stage IV NSCLC (according to the definition of the 8th edition of the American Joint Commission on cancer), who have not been treated and cannot receive radical surgery or radiotherapy confirmed by histopathology, received 3-4 cycles of PD1 antibody ± chemotherapy in the early stage, and the efficacy was evaluated as SD;
- Previously, no EGFR sensitive mutation and ALK, ROS1 gene fusion mutation were detected based on tissue examination;
- There are measurable lesions evaluated by researchers according to RECIST version 1.1;
- The physical state score (ECOG PS) of the eastern cancer cooperation group was 0-1;
Key exclusion criteria (11 listed)
- The patient's compliance is poor and violates the test regulations;
- Patients with positive driver gene are known to carry EGFR mutation or ALK, ROS1 gene translocation;
- There are dysfunction of important organs of liver and kidney, such as myocardial infarction, angina pectoris, liver transaminase significantly increased;
- Serious adverse drug reactions occurred during induction;
- Have suffered from any disease requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days before enrollment;
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 |
|---|---|---|
| PD-1 inhibitorAlso: Stereotactic Body Radiation TherapyAfter receiving PD-1 inhibitor treatment in the first three cycles, patients with locally advanced or advanced NSCLC whose curative effect is evaluated as stable disease receive SBRT combined with PD-1 inhibitor treatment | Drug | – |
Primary outcome
objective response rate (ORR)
Time frame: 2 year
The proportion of patients whose tumors shrink to a certain amount and remain for a certain period of time, including cases of complete response and partial response.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
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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.
the second affiliated hospital of Army medical university
Chongqing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Xinqiao Hospital of Chongqing at 1 site in China.
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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (ORR) (time frame: 2 year). 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 14 Jul 2025.