Actively Recruiting
An Observational Clinical Study of Stereotactic Radiotherapy for Advanced Non-Small Cell Lung Cancer With Stable Disease After PD-1 Inhibitor Treatment
Led by Xinqiao Hospital of Chongqing · Updated on 2025-07-14
20
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
An Observational Clinical Study of Stereotactic Radiotherapy for Advanced Non-Small Cell Lung Cancer With Stable Disease After PD-1 Inhibitor Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and ability to follow study protocol
- Diagnosis of stage IIIB, IIIC, or IV NSCLC confirmed by histopathology, unresectable or ineligible for radical radiotherapy
- Received 3-4 cycles of PD-1 antibody � chemotherapy with stable disease evaluation
- No EGFR sensitive mutation and no ALK or ROS1 gene fusion mutation detected
- Presence of measurable lesions per RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Good heart and lung function
You will not qualify if you...
- Poor compliance or violation of study rules
- Known positive for EGFR mutation or ALK, ROS1 gene translocation
- Dysfunction of major organs including liver and kidneys, such as myocardial infarction or significantly elevated liver transaminases
- Serious adverse drug reactions during induction therapy
- Disease requiring systemic corticosteroids or immunosuppressive drugs within 14 days before enrollment
- Severe infection within 4 weeks before enrollment, including hospitalization for infection, bacteremia, or severe pneumonia
- Active or chronic infections needing systemic antibiotic treatment within 14 days before enrollment
- History of interstitial lung disease, non-infectious pneumonia, or poorly controlled lung diseases like pulmonary fibrosis
- Untreated chronic hepatitis B or active hepatitis C infection
- Known HIV infection
- Participation in other clinical trials or receipt of other investigational drugs within 28 days before enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
the second affiliated hospital of Army medical university
Chongqing, Chongqing Municipality, China, 40037
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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