Actively Recruiting
A Study Evaluating Neoadjuvant Chemoimmunotherapy With Immunosensitizing Radiation for Borderline Resectable Non-Small Cell Lung Cancer
Led by University of Maryland, Baltimore · Updated on 2026-05-06
18
Participants Needed
4
Research Sites
253 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study Evaluating Neoadjuvant Chemoimmunotherapy With Immunosensitizing Radiation for Borderline Resectable Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at study entry
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically confirmed stage II to IIIC (N3) NSCLC considered borderline resectable
- Review and confirmation of resectability by a multidisciplinary thoracic tumor board
- Availability of tumor tissue for biomarker testing including EGFR/ALK status
- No major health conditions that increase surgical risk unacceptably
- Pulmonary function sufficient to tolerate lung surgery as determined by surgeon
- Adequate organ and marrow function (platelets ≥100,000/mm3; hemoglobin ≥8 g/dL; ANC ≥1000/mm3; creatinine ≤1.5 x ULN or creatinine clearance ≥40 mL/min; total bilirubin ≤1.5 x ULN except Gilbert Syndrome up to 3.0 mg/dL; liver enzymes ≤3 x ULN)
- Ability to give informed consent
- Women of childbearing potential must have a negative pregnancy test within 30 days before starting the study
You will not qualify if you...
- Presence of metastatic (stage IV) disease including malignant pleural effusions
- N3 disease involving ipsilateral or contralateral scalene or supraclavicular lymph nodes
- Known sensitizing EGFR mutations or ALK translocation
- Brain metastases confirmed by MRI or CT with contrast
- Active autoimmune diseases that prevent immunotherapy
- Use of systemic corticosteroids (>10 mg prednisone daily) or immunosuppressants within 14 days before enrollment
- Serious or uncontrolled medical disorders
- Large-cell neuroendocrine carcinoma tumor type
- Prior chemotherapy or cancer therapy for early-stage NSCLC
- Prior therapy with anti-PD-(L)1, anti-CTLA-4, or other T-cell targeting antibodies
- Active hepatitis B or C infection (with specific criteria for eligibility)
- Poorly controlled or untreated HIV/AIDS
- Active malignancy within the past 3 years except certain locally curable cancers
- Allergy or hypersensitivity to nivolumab or chemotherapy agents
- History of allogeneic organ transplantation
- Pregnancy, breastfeeding, or unwillingness to use effective birth control during and 90 days after surgery
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Maryland Proton Treatment Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
2
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
3
Upper Chesapeake- Kaufman Cancer Center
Bel Air, Maryland, United States, 21014
Actively Recruiting
4
Baltimore Washington Medical Center- Tate Cancer Center
Glen Burnie, Maryland, United States, 21061
Actively Recruiting
Research Team
M
Matthew Ferris, MD
CONTACT
C
Caitlin Eggleston, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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