OncoMatch/Clinical Trials/NCT06800339
A Study Evaluating Neoadjuvant Chemoimmunotherapy With Immunosensitizing Radiation for Borderline Resectable Non-Small Cell Lung Cancer
Is NCT06800339 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Nivolumab and Chemotherapy for non-small cell lung cancer.
Treatment: Nivolumab · Chemotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR L858R
Participants with known sensitizing EGFR (L858R or Exon 19 deletion) mutations ... are excluded
Required: EGFR exon 19 deletion
Participants with known sensitizing EGFR (L858R or Exon 19 deletion) mutations ... are excluded
Required: ALK fusion
Participants with known ... ALK translocation ... are excluded
Disease stage
Required: Stage II, IIIA, IIIB, IIIC(N3) (8th International Association for the Study of Lung Cancer)
Excluded: Stage IV
stage II-IIIC(N3) NSCLC (per the 8th International Association for the Study of Lung Cancer); Presence of metastatic (Stage IV) disease, including malignancy pleural effusions [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Prior administration of chemotherapy or any other cancer therapy for early-stage NSCLC
Cannot have received: anti-PD-(L)1 therapy
Prior therapy with an anti-PD-(L)1, anti-CTLA-4 antibody or any other antibody targeting t-cell co-regulatory pathways
Cannot have received: anti-CTLA-4 therapy
Prior therapy with an anti-PD-(L)1, anti-CTLA-4 antibody or any other antibody targeting t-cell co-regulatory pathways
Cannot have received: antibody targeting t-cell co-regulatory pathways
Prior therapy with an anti-PD-(L)1, anti-CTLA-4 antibody or any other antibody targeting t-cell co-regulatory pathways
Lab requirements
Blood counts
Platelet count ≥ 100,000/mm3; Hemoglobin ≥ 8 g/dL; Absolute neutrophil count (ANC) ≥ 1000/mm3
Kidney function
Creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min
Liver function
Total bilirubin ≤ 1.5 x ULN (except Gilbert Syndrome < 3.0 mg/dL); AST, ALT, Alkaline phosphatase ≤ 3 x ULN per local testing
Adequate normal organ and marrow function defined below: Platelet count ≥ 100,000/mm3; Hemoglobin ≥ 8 g/dL; ANC ≥ 1000/mm3; Creatinine ≤ 1.5 x ULN or CrCl ≥ 40 mL/min; Total bilirubin ≤ 1.5 x ULN (except Gilbert Syndrome < 3.0 mg/dL); AST, ALT, Alkaline phosphatase ≤ 3 x ULN per local testing
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial 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
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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