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New treatment option for Non Small Cell Lung Cancer
Official title A Study of Targeted Radiation Therapy in People With Non-Small Cell Lung Cancer (NSCLC)
ClinicalTrials.gov ID: NCT05657873
What this study is testing
What is Anti-PD-(L)1 based immunotherapy?
Anti-PD-(L)1 based immunotherapy is an investigational medicine, being studied as a potential treatment for non small cell lung cancer.
Also referred to as Standard of Care.
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 purpose of this study is to see whether adding liver stereotactic ablative radiotherapy/L-SABR to standard drug therapy is better than standard drug therapy alone for people with metastatic non-small cell lung cancer/NSCLC.
- 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
- Be greater than 18 years of age on day of signing informed consent.
- Have a histologically confirmed diagnosis of stage IV NSCLC (includes patients who have progressed on durvalumab for Stage III NSCLC) without known...
- Newly diagnosed metastatic non-small cell lung cancer (NSCLC), including both de novo and secondary metastatic disease, with one or more liver...
- Plan to initiate standard of care anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy for at least 3 cycles o Regimens combining...
- Have a performance status of 0-2 on the ECOG Performance Scale.
You likely can't join if
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how...
- Patients with prior external beam radiation therapy to the liver.
- Patients with known active Hepatitis B or Hepatitis C.
- Patients with immunosuppression including pharmacological immunosuppression with chronic steroids or immune modulators like cyclosporin or...
- Patients who are pregnant or breastfeeding
- Men or women not using effective contraception.
See the full eligibility criteria
- Be greater than 18 years of age on day of signing informed consent.
- Have a histologically confirmed diagnosis of stage IV NSCLC (includes patients who have progressed on durvalumab for Stage III NSCLC) without known mutations in (EGFR) or BRAF or rearrangements in ALK (anaplastic...
- Newly diagnosed metastatic non-small cell lung cancer (NSCLC), including both de novo and secondary metastatic disease, with one or more liver metastases
- Plan to initiate standard of care anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy for at least 3 cycles o Regimens combining anti-CTLA-4 immunotherapy with anti-PD-1 (e.g., ipilimumab plus nivolumab) or...
- Have a performance status of 0-2 on the ECOG Performance Scale.
- Liver function tests:
- Total Bilirubin ≤ 1.5 x ULN
- AST/ ALT ≤ 5 x ULN
- Eligible for L- SABR to all liver metastases as determined by the treating radiation oncologist
- Patients with known HIV are eligible provided they are under treatment with effective anti-retroviral therapy with CD4 count \>200 cells/microliter within 28 days prior to registration
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen should be...
- Patients with prior external beam radiation therapy to the liver.
- Patients with known active Hepatitis B or Hepatitis C.
- Patients with immunosuppression including pharmacological immunosuppression with chronic steroids or immune modulators like cyclosporin or methotrexate and patients with active autoimmune disease.
- Patients who are pregnant or breastfeeding
- Men or women not using effective contraception.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
- Allentown, Pennsylvania, United States
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 Miami, Florida, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States and 3 more location(s). 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.