Spatially fractionated radiotherapy combined with standard treatment for oligoprogressive non-small cell lung cancer.
A Prospective, Single-Arm Phase II Clinical Trial of Standard Systemic Therapy Combined With Spatial Fractionated Radiotherapy (SFRT) for Oligoprogressive Non-small Cell Lung Cancer (NSCLC)
It tests whether adding spatially fractionated radiotherapy to standard systemic therapy helps people with oligoprogressive non-small cell lung cancer who have progressed after at least one prior systemic treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07193641 on ClinicalTrials.gov |
What this trial studies
This phase 2 interventional study compares adding spatially fractionated radiotherapy (SFRT) to continued standard systemic therapy versus standard systemic therapy alone for patients with oligoprogressive non-small cell lung cancer. Participants with up to five progressing lesions receive SFRT (dose and fractionation determined by the radiation oncologist) targeting eligible lesions, while continuing their prescribed systemic therapy such as chemotherapy, targeted therapy, or immunotherapy. Key eligibility includes progression after at least one line of systemic therapy, lesion size suitable for lattice planning (≥4.5 cm), ECOG performance status 0-2, and no new or enlarging untreated brain metastases. Outcomes include progression-free survival measured by regular imaging and clinical follow-up, with safety and treatment response closely monitored.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed NSCLC who have up to five progressive lesions after at least one prior systemic therapy, ECOG 0-2, a target lesion ≥4.5 cm or otherwise suitable for lattice SFRT, and stable or no active brain metastases.
Not a fit: Patients with widespread progression (>5 lesions), lesions too small for lattice planning, recent radiotherapy to the target lesion (within 6 months), unstable brain metastases, or poor performance status are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could extend progression-free survival and delay the need to change systemic therapy for patients with oligoprogressive NSCLC.
How similar studies have performed: Previous trials have shown that local ablative therapies like SBRT can improve outcomes in oligometastatic NSCLC, but SFRT/lattice approaches are newer and have only limited clinical data so far.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang
- 2nd Affiliated Hospital, School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Ting Zhang, phD.
- Email: zezht@zju.edu.cn
- Phone: +8657187783521
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.