RecruitingPhase 1NCT06800339

A Study Evaluating Neoadjuvant Chemoimmunotherapy With Immunosensitizing Radiation for Borderline Resectable Non-Small Cell Lung Cancer

A Phase I, Single-Arm, Single-Institution Study Evaluating Neoadjuvant Chemoimmunotherapy With Immunosensitizing Radiation for Borderline Resectable Non-Small Cell Lung Cancer


Sponsor

University of Maryland, Baltimore

Enrollment

18 participants

Start Date

Apr 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research study is to find out if adding radiation prior to chemoimmunotherapy and surgery is effective for people with non-small cell lung cancer (NSCLC) who have the potential for surgery. Standard of Care Chemoimmunotherapy: For this study, standard of care chemotherapy will be used. This means this is the type of chemotherapy that is normal for your cancer. In addition to the chemotherapy, you will also receive the immunotherapy drug, nivolumab. This will be administered intravenously once every 3 weeks for up to 3 cycles (i.e. 9 weeks of total systemic therapy), prior to surgical resection assessment. This combination is made up of the chemotherapy drugs carboplatin or cisplatin along with pemetrexed, paclitaxel or gemcitabine, and the immunotherapy drug is nivolumab. The chemotherapy is used to kill cancer cells, and the immunotherapy enables your immune system to attack cancer cells. Stereotactic Body Radiation Therapy (SBRT) SBRT is when radiation is delivered at higher doses over a smaller period of time. For this study, you will receive three doses of radiation delivered every other day, for three total days. The final dose of radiation will happen within 7 days of starting chemoimmunotherapy. You will be followed for up to 100 days following your last chemoimmunotherapy dose to monitor for potential side effects. Following this you will continue with your standard follow up with your doctor. During the standard follow-up time, study staff will review your charts to see if there have been any new updates with your cancer following treatment so they can tell how this treatment affects how long patients live and whether it helps avoid recurrence of the cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of chemotherapy, immunotherapy, and targeted radiation given before surgery in people with non-small cell lung cancer (NSCLC) that is difficult to remove but potentially curable — sometimes called 'borderline resectable' cancer. **You may be eligible if...** - You are 18 or older - You are in good general health (able to perform daily activities) - You have stage II–IIIC non-small cell lung cancer confirmed by biopsy - Your cancer has been reviewed by a specialist cancer team and considered potentially removable with treatment first **You may NOT be eligible if...** - Your cancer has spread to distant organs outside the chest - You have already received radiation or chemotherapy for this cancer - You have significant autoimmune disease or other conditions that would prevent immunotherapy - You have serious heart or lung problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab

This will be administered intravenously once every 3 weeks for up to 3 cycles (i.e. 9 weeks of total systemic therapy)

DRUGChemotherapy

Chemotherapy options include: carboplatin or cisplatin along with pemetrexed, paclitaxel or gemcitabine

RADIATIONSBRT

Three fractions of radiation delivered every other day, for three total days. The final dose of radiation will happen within 7 days of starting chemoimmunotherapy

PROCEDURESurgical Resection

Post treatment patient will be evaluated for surgical resection


Locations(4)

Maryland Proton Treatment Center

Baltimore, Maryland, United States

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, United States

Upper Chesapeake- Kaufman Cancer Center

Bel Air, Maryland, United States

Baltimore Washington Medical Center- Tate Cancer Center

Glen Burnie, Maryland, United States

View Full Details on ClinicalTrials.gov

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NCT06800339


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