A Study Evaluating Neoadjuvant Chemoimmunotherapy With Immunosensitizing Radiation for Borderline Resectable Non-Small Cell Lung Cancer (NCT06800339)
A Phase I, Single-Arm, Single-Institution Study Evaluating Neoadjuvant Chemoimmunotherapy With Immunosensitizing Radiation for Borderline Resectable Non-Small Cell Lung Cancer
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (16 items) and avoid the listed exclusions (19 items).
Location: Maryland Proton Treatment Center — Baltimore, Maryland
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Presence of metastatic (Stage IV) disease, including malignancy pleural effusions.
- Participants with N3 disease involving ipsilateral or contralateral scalene or supraclavicular lymph nodes. In the case of clinical suspicion for involvement of these lymph nodes, pathologic confirmation and biopsy may be pursued to determine final eligibility.
- Participants with known sensitizing EGFR (L858R or Exon 19 deletion) mutations or ALK translocation. If testing is done, an FDA approved assay should be used and testing can be performed locally.
- Participants with brain metastases are excluded from this study. All patients should have pre-study MRI brain or CT head with contrast to confirm the absence of intracranial disease, per standard of care staging procedures.
- Participants with active autoimmune disease which would preclude immunotherapy. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of external trigger are permitted to enroll.
- Participants with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses \>10 mg daily prednisone equivalent, are permitted in the absence of autoimmune disease.
- Participants with serious or uncontrolled medical disorders.
- Participants with large-cell neuroendocrine carcinoma tumor histology.
- Prior administration of chemotherapy or any other cancer therapy for early-stage NSCLC.
- Prior therapy with an anti-PD-(L)1, anti-CTLA-4 antibody or any other antibody targeting t-cell co-regulatory pathways.
- Participants with active hepatitis B (positive hepatitis B surface antigen) or hepatitis C virus (positive HCV RNA).
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (4 Sites)
- Maryland Proton Treatment Center — Baltimore, Maryland
- University of Maryland Greenebaum Cancer Center — Baltimore, Maryland
- Upper Chesapeake- Kaufman Cancer Center — Bel Air, Maryland
- Baltimore Washington Medical Center- Tate Cancer Center — Glen Burnie, Maryland
📞 Contact the Study Coordinator
Phone: (410) 328-6080
Email: matthew.ferris@umm.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Non-Small Cell Lung Cancer
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- Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1) — La Jolla, California
- PhI/II Study of Amivantamab and Tepotinib Combo in MET-altered Non-small Cell Lung Cancer — Houston, Texas
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- BBO-11818 in Adult Subjects With KRAS Mutant Cancer — Los Angeles, California
Explore by condition: All Non-Small Cell Lung Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.