Efficacy and Safety of Super-hyperfractionation Pulse Radiotherapy Combined With ICIs for Advanced NSCLC

Army Medical University of People's Liberation Army

Status: Enrolling

Conditions: Immune Checkpoint Inhibitor; Radiotherapy; Lung Cancer

Treatments: Radiation: Super-hyperfractionation Pulse Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05754203

XQonc-020

Details and patient eligibility

About

Investigators intend to combine low-dose hypersensitivity with high-dose immunopotentiation effect, and use super-hyperfractionation pulse radiotherapy, which is expected to achieve the effect of in situ vaccine that can enhance tumor killing, protect normal tissues, reduce immune cell damage and enhance tumor immunogenicity at the same time, and play a stronger immunopotentiation effect in combined immunotherapy. Thereby inducing a stronger abscopal effect of radiotherapy.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Informed consent has been signed and, in the judgment of the investigator, the patient is able to comply with the study protocol and sign a written informed consent.
2. Participants diagnosed with stage IIIB or above non-small cell lung cancer confirmed by histopathology (whether newly diagnosed or not) meet the requirements of SBRT radiotherapy (mass limited, less than 5 cm) and immune checkpoint inhibitor therapy (according to CSCO guidelines).
3. Age ≥ 18 and less than 75.
4. Eastern Cooperative Oncology Group Performance Status Score (ECOG PS) 0-3.

Exclusion Criteria

1. The participant's compliance is poor and the test regulations are violated.
2. Dysfunction of important organs of liver and kidney, such as myocardial infarction, angina pectoris, and significant increase of liver transaminase.
3. Any disease requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to enrollment.
4. Serious infection within 4 weeks before enrollment, including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia.
5. Severe chronic or active infections (including tuberculosis infection) requiring systemic (oral or intravenous) antibiotic therapy within 14 days before enrollment.
6. Participants with untreated chronic hepatitis B or HBV carriers with hepatitis B virus (HBV) DNA ≥ 500 IU/mL, or patients with active hepatitis C virus (HCV) should be excluded. Note: Inactive hepatitis B, HBsAg carriers, treated and stable hepatitis B carriers (HBV DNA < 500 IU/mL), and cured hepatitis C patients can be included in the group.
7. Known history of HIV infection.
8. Receive any other investigational drug treatment or participate in other clinical trials within 28 days.
9. There are no contraindications to stereotactic radiotherapy and immune checkpoint inhibitors.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Super-hyperfractionation Pulse Radiotherapy Combined With Immune Checkpoint Inhibitor

Experimental group

Description:

Radiotherapy design: a single dose of 0.5Gy, 16 consecutive pulses with an interval of 3 minutes (0.5Gy \* 16F), total dose DT: 8Gy; Immunotherapy: PD-1/PD-L1 monoclonal antibodies conforming to CSCO guidelines for lung cancer indications, including Carrilizumab, Tirelizumab, Teripril, Paborizumab, etc., conventional therapeutic dose, Q3W, until progression or the investigator judges that there is no longer clinical benefit or intolerable side effects.

Treatment:

Radiation: Super-hyperfractionation Pulse Radiotherapy