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

NCT05754203 | Recruiting

• 1 other identifier: XQonc-020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Lung Cancer; Immune Checkpoint Inhibitor; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• iORR

  24 weeks

Study Arms (1)

Super-hyperfractionation Pulse Radiotherapy Combined With Immune Checkpoint Inhibitor

EXPERIMENTAL

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.

Radiation: Super-hyperfractionation Pulse Radiotherapy

Interventions

Super-hyperfractionation Pulse Radiotherapy RADIATION

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.

Also known as: Immune Checkpoint Inhibitor

Super-hyperfractionation Pulse Radiotherapy Combined With Immune Checkpoint Inhibitor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).
• Age ≥ 18 and less than 75.
• Eastern Cooperative Oncology Group Performance Status Score (ECOG PS) 0-3.

You may not qualify if:

• The participant's compliance is poor and the test regulations are violated.
• Dysfunction of important organs of liver and kidney, such as myocardial infarction, angina pectoris, and significant increase of liver transaminase.
• Any disease requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to enrollment.
• Serious infection within 4 weeks before enrollment, including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia.
• Severe chronic or active infections (including tuberculosis infection) requiring systemic (oral or intravenous) antibiotic therapy within 14 days before enrollment.
• 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.
• Known history of HIV infection.
• Receive any other investigational drug treatment or participate in other clinical trials within 28 days.
• There are no contraindications to stereotactic radiotherapy and immune checkpoint inhibitors.

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing: lead

Study Sites (2)

the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, 40037, China

RECRUITING

Jianguo Sun

Chongqing, 400000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Jianguo Sun

  Department of Oncology, Xinqiao Hospital, Army Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianguo Sun, doctor

CONTACT

+862368774490; sunjianguo@tmmu.edu.cn

Lin-Peng Zheng

CONTACT

+862368774395; zlpxiangya@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of oncology department, Clinical Professor

Study Record Dates

• First Submitted: February 12, 2023
• First Posted: March 3, 2023
• Study Start: August 1, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)