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

Lung Cancer Clinical Trial

Official title:

Efficacy and Safety of Super-hyperfractionation Pulse Radiotherapy Combined With Immune Checkpoint Inhibitor for Advanced Non-small Cell Lung Cancer.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05754203
• Other study ID #: XQonc-020
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: February 2024
• Source: Xinqiao Hospital of Chongqing
• Contact: Jianguo Sun, doctor
• Phone: +862368774490
• Email: sunjianguo[@]tmmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immune Checkpoint Inhibitor
• Lung Cancer
• Lung Neoplasms
• Radiotherapy

Intervention

Radiation:
• Super-hyperfractionation Pulse Radiotherapy
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.

Locations

Country	Name	City	State
China	Jianguo Sun	Chongqing
China	the second affiliated hospital of Army medical university	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate	The proportion of patients with tumor volume reduced by 30% and maintained for more than 4 weeks. Sum of the proportions of complete response (CR) and partial response (PR)	12 weeks
Secondary	iORR	The objective response rate away from the radiation field	24 weeks