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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
This will be administered intravenously once every 3 weeks for up to 3 cycles (i.e. 9 weeks of total systemic therapy)
Chemotherapy options include: carboplatin or cisplatin along with pemetrexed, paclitaxel or gemcitabine
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
Post treatment patient will be evaluated for surgical resection
Maryland Proton Treatment Center
Baltimore, Maryland, United States
RECRUITINGUniversity of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
RECRUITINGUpper Chesapeake- Kaufman Cancer Center
Bel Air, Maryland, United States
RECRUITINGBaltimore Washington Medical Center- Tate Cancer Center
Glen Burnie, Maryland, United States
RECRUITINGTolerability of Adding Sub-ablative, Immunosensitizing, Radiotherapy to Standard of Care Neoadjuvant Chemoimmunotherapy
Evaluate the tolerability of adding sub-ablative, immunosensitizing, radiotherapy to standard of care neoadjuvant chemoimmunotherapy prior to surgery for resectable NSCLC, measured by the rate of DLTs from time of neoadjuvant therapy initiation to start of definitive therapy (either surgery or chemoimmunotherapy initiation).
Time frame: 20 weeks post initiation of neoadjuvant therapy
Number of adverse events assessment by CTCAE v5.0 that are related to treatment
Determine the safety of adding sub-ablative, immunosensitizing, radiotherapy to standard of care neoadjuvant chemoimmunotherapy prior to definitive resection for resectable NSCLC, measured by the frequency of drug related adverse events, including serious adverse events, occurring up to the initiation of definitive therapy (either surgery or chemoimmunotherapy initiation). Safety will be measured by the frequency of drug related adverse events, including serious adverse events (defined by CTCAE version 5), occurring up until the time of definitive therapy initiation (either surgery or chemoradiotherapy).
Time frame: 20-22 weeks post initiation of neoadjuvant therapy
Pathologic Complete Response Rate (pCR)
Estimate the rate of pathologic complete response after adding immunosensitizing radiotherapy to neoadjuvant chemoimmunotherapy prior to definitive resection. pCR is defined as lack of any viable tumor cells after complete evaluation in the resected lung cancer specimen and all sampled regional lymph nodes as determined by central pathology review and described by IASLC 2020 assessment criteria. The measure of interest is the proportion of resected patients with 0% residual viable tumor cells within all resected tissue as assessed by the central pathology review.
Time frame: 20-22 weeks post initiation of neoadjuvant therapy
Major Pathologic Response Rate (MPR)
Estimate the rate of major pathologic response after adding immunosensitizing radiotherapy to neoadjuvant chemoimmunotherapy prior to definitive resection. MPR is defined as ≤ 10% viable tumor cells in resected tumor after complete evaluation in the resected lung cancer specimen as determined by central pathology review and described by IASLC 2020 assessment criteria. The measure of interest is the proportion of resected patients with ≤ 10% residual viable tumor cells within all resected tissue as assessed by the central pathology review.
Time frame: 20-22 weeks post initiation of neoadjuvant therapy
Measure rate of definitive resection
Establish the rate of definitive resection for patients with borderline resectable NSCLC treated with subablative radiotherapy followed by neoadjuvant chemoimmunotherapy. Rate of definitive resection will be measured as the percentage of participants who undergo a complete R0 resection of their disease after receiving neoadjuvant subablative radiotherapy followed by chemoimmunotherapy out of all treated participants.
Time frame: 1 year post completion of accrual
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