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New treatment option for Non Small Cell Lung Cancer
Official title A Study on Using SFRT With Standard Treatment for Oligoprogressive NSCLC
ClinicalTrials.gov ID: NCT07193641
What this study is testing
What is The systemic therapy?
The systemic therapy is an investigational medicine, being studied as a potential treatment for non small cell lung cancer.
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 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?
- Phase 2: a mid-size study of how well it works
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 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)...
- 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.
You likely can't join if
- Presence of other systemic diseases or severe comorbidities that the investigator believes would make the patient unsuitable for the study or...
- 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...
- Mental illness or social situations that might limit the patient's ability to comply with study requirements (e.g., drug abuse).
- Participation in other treatment 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...
See the full eligibility 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...
- 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...
- For women of childbearing potential, a negative pregnancy test within 7 days prior to registration.
- 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...
- 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...
- Mental illness or social situations that might limit the patient's ability to comply with study requirements (e.g., drug abuse).
- Participation in other treatment 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...
- 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...
- 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.
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.