Using Stereotactic Radiotherapy for Lung Cancer Patients with Stable Disease After Immunotherapy

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

This study is testing if adding a type of targeted radiation therapy can help lung cancer patients, who have stable disease after immunotherapy, live longer and improve their overall health.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Xinqiao Hospital of Chongqing (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT05486650 on ClinicalTrials.gov

What this trial studies

This observational study investigates the effects of stereotactic radiotherapy (SBRT) on patients with advanced non-small cell lung cancer (NSCLC) who have achieved stable disease after treatment with PD-1 inhibitors. The hypothesis is that SBRT can enhance the immune response by promoting tumor antigen release and activating T cells, potentially leading to improved long-term survival rates. Patients will be monitored for changes in their disease status following the addition of SBRT to their treatment regimen. The study aims to evaluate the objective remission rate and overall survival outcomes in this patient population.

Who should consider this trial

Good fit: Ideal candidates include patients with stage IIIB, IIIC, or IV NSCLC who have stable disease after receiving PD-1 inhibitors and meet specific eligibility criteria.

Not a fit: Patients with known driver gene mutations or those who have not achieved stable disease after immunotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve long-term survival rates for patients with advanced lung cancer who have not responded fully to immunotherapy.

How similar studies have performed: While the approach of combining radiotherapy with immunotherapy is being explored, this specific observational study is novel and has not been extensively tested in this context.

Eligibility criteria

Inclusion Criteria:

1. Informed consent has been signed, and according to the judgment of the investigator, the patient can comply with the study protocol;
2. 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;
3. Previously, no EGFR sensitive mutation and ALK, ROS1 gene fusion mutation were detected based on tissue examination;
4. There are measurable lesions evaluated by researchers according to RECIST version 1.1;
5. The physical state score (ECOG PS) of the eastern cancer cooperation group was 0-1;
6. Good cardiopulmonary function

Exclusion Criteria:

1. The patient's compliance is poor and violates the test regulations;
2. Patients with positive driver gene are known to carry EGFR mutation or ALK, ROS1 gene translocation;
3. There are dysfunction of important organs of liver and kidney, such as myocardial infarction, angina pectoris, liver transaminase significantly increased;
4. Serious adverse drug reactions occurred during induction;
5. Have suffered from any disease requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days before enrollment;
6. Severe infection occurred within 4 weeks before enrollment, including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia;
7. Severe chronic or active infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibiotic treatment within 14 days before enrollment;
8. Have a history of interstitial lung disease, non infectious pneumonia or poorly controlled diseases, including pulmonary fibrosis, acute lung disease, etc;
9. 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;
10. Known history of HIV infection;
11. Received any other trial drug treatment or participated in other clinical trials within 28 days.

Where this trial is running

Chongqing, Chongqing Municipality

• the second affiliated hospital of Army medical university — Chongqing, Chongqing Municipality, China (Recruiting)

Conditions Non Small Cell Lung Cancer