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New treatment option for Metastatic Non-Small Cell Lung Cancer
Official title Stereotactic Body Radiotherapy for Oligo-Progression Metastatic Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06523673
What this study is testing
What is second-line systemic therapy?
second-line systemic therapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic non-small cell lung cancer.
Also referred to as docetaxel-based chemotherapy, albumin-bound paclitaxel-based chemotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if Stereotactic Body Radiotherapy (SBRT) can treat the oligo-progressive metastatic non-small cell lung cancer (NSCLC) after first-line chemotherapy. The main questions it aims to answer are: Does SBRT improve progression-free survival in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy?
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- Currently participating in an treatment clinical study treatment that may affect this study, or have been treated with another investigational drug...
- 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.
See the full eligibility 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...
- 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...
- 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...
- 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.
- Currently participating in an treatment 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.