A Study on Using SFRT With Standard Treatment for Oligoprogressive NSCLC

NCT ID: NCT07193641

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-15
• Study Completion Date: 2028-06-15

Brief Summary

The goal of this clinical trial is to learn if spatially fractionated radiotherapy (SFRT) combined with standard systemic therapy can treat oligoprogressive non-small cell lung cancer (NSCLC) in patients who have progressed after at least one line of systemic therapy. The main question it aims to answer is:

• Can the combination of SFRT and standard systemic therapy improve progression-free survival (PFS) compared to standard systemic therapy alone?

Participants will:

• Undergo SFRT treatment for oligoprogressive lesions, with specific dose fractionation determined by the radiation oncologist based on clinical parameters.
• Continue their standard systemic therapy, which may include chemotherapy, targeted therapy, or immunotherapy, as adjusted by their treating physician.
• Have regular follow-up assessments, including imaging studies to evaluate treatment response and monitor for disease progression.

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SFRT plus systemic therapy

Group Type: EXPERIMENTAL

Spatially Fractionated Radiotherapy (SFRT)+Stereotactic Body Radiation Therapy (SBRT)

Intervention Type: RADIATION

The intervention includes SFRT for larger oligoprogressive lesions (≥4.5 cm in diameter), utilizing image-guided CT, including 4D-CT, with Lattice technique planning. The dose fractionation will be determined by the radiation oncologist based on clinical parameters, with peak doses ranging from 6-15 Gy/Fx and valley doses from 1.8-4 Gy/Fx, typically in 1-5 fractions.

For smaller oligoprogressive lesions, stereotactic body radiotherapy (SBRT) or intensity-modulated radiotherapy (IMRT) will be selected based on clinical parameters.

The systemic therapy

Intervention Type: DRUG

Continuation or switch of prior standard regimen (chemotherapy, targeted TKI, or PD-1/PD-L1 inhibitor) at investigator discretion until further progression or intolerable toxicity.

Interventions

Spatially Fractionated Radiotherapy (SFRT)+Stereotactic Body Radiation Therapy (SBRT)

The intervention includes SFRT for larger oligoprogressive lesions (≥4.5 cm in diameter), utilizing image-guided CT, including 4D-CT, with Lattice technique planning. The dose fractionation will be determined by the radiation oncologist based on clinical parameters, with peak doses ranging from 6-15 Gy/Fx and valley doses from 1.8-4 Gy/Fx, typically in 1-5 fractions.

For smaller oligoprogressive lesions, stereotactic body radiotherapy (SBRT) or intensity-modulated radiotherapy (IMRT) will be selected based on clinical parameters.

Intervention Type: RADIATION

The systemic therapy

Continuation or switch of prior standard regimen (chemotherapy, targeted TKI, or PD-1/PD-L1 inhibitor) at investigator discretion until further progression or intolerable toxicity.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 18 years or older, regardless of sex.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less, with an expected survival of more than 3 months.
• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with oligometastatic disease (up to 5 separate progressive lesions), having received and progressed after at least one line of systemic therapy (chemotherapy, targeted therapy, or immunotherapy).
• The target lesion for radiotherapy has not been previously irradiated, or it has been more than 6 months since the last radiotherapy.
• The diameter of the target lesion is at least 4.5 cm, suitable for lattice radiotherapy planning.
• No new or enlarged brain metastases; if brain metastases were previously treated with standard radiotherapy, they must be stable.
• Adequate hematologic and biochemical profiles, including hemoglobin ≥9.0 g/dL, absolute neutrophil count (ANC) ≥1500/mm³, platelet count ≥100,000/mm³, total bilirubin ≤1.5 times the upper limit of normal (ULN) (or direct bilirubin ≤ULN if total bilirubin >1.5 times ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times ULN (or ≤5 times ULN if liver involvement is present), and creatinine ≤1.5 times ULN (or glomerular filtration rate [GFR] >60 mL/min if creatinine >1.5 times ULN).
• For women of childbearing potential, a negative pregnancy test within 7 days prior to registration.

Exclusion Criteria

• Presence of other systemic diseases or severe comorbidities that the investigator believes would make the patient unsuitable for the study or significantly interfere with the assessment of the safety and toxicity of the study regimen.
• Active autoimmune diseases requiring systemic treatment, or a history of severe autoimmune diseases, such as interstitial lung disease.
• Uncontrolled concurrent diseases, including but not limited to: infections requiring systemic treatment, active tuberculosis (TB), severe or chronic gastrointestinal diseases associated with diarrhea (e.g., Crohn's disease), active hepatitis B (defined by positive hepatitis B surface antigen [HBsAg]), active hepatitis C (defined by positive hepatitis C virus [HCV] RNA), symptomatic congestive heart failure, unstable angina, unstable cardiac arrhythmias, myocardial infarction within the past 6 months, or congestive heart failure requiring continuous maintenance therapy for life-threatening ventricular arrhythmias.
• Mental illness or social situations that might limit the patient's ability to comply with study requirements (e.g., drug abuse).
• Participation in other interventional clinical trials with experimental drugs that could be considered treatment for the primary tumor.
• Allergy to immunotherapy drugs, or discontinuation of immunotherapy drugs due to adverse events in the past, or grade 3 or higher immune-related adverse events during previous immunotherapy, or any grade of immune-related neurological or ocular adverse events.
• History of other active malignancies within the past 6 months, except for non-melanoma skin cancer, papillary thyroid cancer, prostate cancer, or cervical carcinoma in situ that have been treated with curative intent and are currently considered to have a recurrence risk of less than 30%.
• History of allogeneic organ transplantation or active primary immunodeficiency.
• Any other condition that the investigator deems a valid reason for exclusion, such as potential situations inconsistent with the clinical protocol.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

2nd Affiliated Hospital, School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ting Zhang, phD.

Role: CONTACT

zezht@zju.edu.cn

+8657187783521

Facility Contacts

Ting Zhang phD

Role: primary

zezht@zju.edu.cn

+86571-87783521

phD

Role: backup

Other Identifiers

Y202-0552

Identifier Type: -

Identifier Source: org_study_id