Using Stereotactic Body Radiotherapy for treating metastatic lung cancer with limited progression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of Stereotactic Body Radiotherapy (SBRT) in patients with oligo-progressive metastatic non-small cell lung cancer (NSCLC) following first-line chemotherapy. It is a phase 3, randomized, controlled study comparing SBRT combined with standard of care (SOC) against SOC alone. Participants will receive SBRT on progressive sites while continuing maintenance therapy, and their outcomes will be monitored through regular assessments and quality of life questionnaires. The goal is to determine if SBRT can enhance progression-free survival, overall survival, and quality of life for these patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years. Gender is not limited.
* Histologically and/or cytologically confirmed stage IV metastatic NSCLC.
* Eastern Cooperative Oncology Group (ECOG) score of 0-2.
* Patients who had prior first-line chemotherapy with clinical benefit lasting for ≥3 months.
* Driver gene-negative NSCLC patients with oligo-progression during first-line chemotherapy combined with Immune Checkpoint Inhibitors (ICI). Driver gene-positive NSCLC patients, such as epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) fusion positivity, are allowed to enroll if oligo-progression occurred during treatment with first-line chemotherapy combined with bevacizumab ± ICI after failure of Tyrosine Kinase Inhibitor (TKI) therapy.
* Progressive sites were assessed as ≤5 according to RECIST v1.1 criteria combined with positron emission tomography / computertomography (PET/CT), and all were located extracranially. Progressive lymph node lesions are counted by region, with each lymph node region amenable to concurrent SBRT (which may contain multiple progressive lymph nodes) counted as 1 progressive site.
* All progressive sites should be visible on radiologic imaging and assessed as suitable for SBRT treatment by a radiotherapist.
* Intracranial progressive lesions and symptomatic lesions can be treated with palliative radiotherapy and local therapy prior to enrollment and are not counted within the oligo-progressive sites.
* Expected survival time greater than 3 months.
* Comprehensive examination completed within 28 days prior to enrollment in the study and a complete blood count/differential, collected within 15 days, showing that the patient has normal internal organ function and normal bone marrow function.
* Negative serum or urine pregnancy test in females of childbearing age within 14 days prior to study enrollment.
* Patients are willing to provide written informed consent and must be willing to adhere to the prescribed follow-up schedule.

Exclusion Criteria:

* Currently participating in an interventional clinical study treatment that may affect this study, or have been treated with another investigational drug or investigational device that may affect this study within 4 weeks prior to first treatment.
* Pregnant or lactating women.
* Progression sites deemed unsuitable for SBRT treatment as assessed by radiotherapy specialists.
* Presence of untreated intracranial metastases or symptomatic progressive sites.
* History of malignancy other than NSCLC or untreated primary malignancy within the past 3 years.
* Serious active comorbidities that would interfere with treatment in this study.
* History or evidence of disease that could interfere with the results of the trial, prevent the subject from participating in the study throughout, abnormal values of treatment or laboratory tests, or other conditions that, in the opinion of the investigator, make enrollment inappropriate.

Where it's running

• Second Affiliated Hospital, School of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Fuming Qiu, PhD — Second Affiliated Hospital, Zhejiang University, School of Medicine
• Study coordinator: Fuming Qiu, PhD
• Email: qiufuming@zju.edu.cn
• Phone: 86+13858005908

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.