This phase I trial tests the safety, side effects and effectiveness of adding radiation to standard of care chemoimmunotherapy, with nivolumab, carboplatin or cisplatin and paclitaxel or pemetrexed or gemcitabine, for the treatment of patients with stage II-IIIC non small cell lung cancer that may be able to be removed by surgery (borderline resectable). Stereotactic body radiation therapy (SBRT) is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make DNA and may kill cancer cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. Giving SBRT with chemoimmunotherapy may be safe and effective in treating patients with borderline resectable stage II-IIIC non small cell lung cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06800339.
Locations matching your search criteria
United States
Maryland
Baltimore
University of Maryland/Greenebaum Cancer CenterStatus: Active
Contact: Matthew Jeffrey Ferris
Phone: 410-369-5215
Bel Air
UM Upper Chesapeake Medical CenterStatus: Active
Contact: Kamila Nowak Choi
Phone: 443-643-1199
PRIMARY OBJECTIVE:
I. To assess the tolerability of adding sub-ablative, immunosensitizing, radiotherapy to standard of care neoadjuvant chemoimmunotherapy prior to surgery for resectable non small cell lung cancer (NSCLC), measured by the rate of dose limiting toxicity (DLTs) from time of neoadjuvant therapy initiation to start of definitive therapy (either surgery or chemoimmunotherapy initiation).
SECONDARY OBJECTIVES:
I. To evaluate 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).
II. To determine the rate of pathologic complete response after adding immunosensitizing radiotherapy to neoadjuvant chemoimmunotherapy prior to definitive resection.
III. To determine the rate of major pathologic response after adding immunosensitizing radiotherapy to neoadjuvant chemoimmunotherapy prior to definitive resection.
IV. To establish the rate of definitive resection for patients with borderline resectable NSCLC treated with subablative radiotherapy followed by neoadjuvant chemoimmunotherapy.
OUTLINE:
Patients undergo SBRT for 3 treatments given over 8 days with treatments being given 40-120 hours apart. Within 7 days of the last dose of radiation patients receive nivolumab intravenously (IV) and carboplatin IV or cisplatin IV on day 1 and paclitaxel IV or pemetrexed (for patients with nonsquamous histology) IV on day 1 or gemcitabine (for patients with squamous histology) IV on days 1 and 8 of each cycle. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients are deemed resectable candidates then undergo surgical resection within 6 weeks. Patients undergo bronchoscopy and brain magnetic resonance imaging (MRI) during screening and computed tomography (CT)/positron emission tomography (PET) scan and blood sample collection throughout the study.
After completion of study treatment, patients are followed up ever 3-6 months for 2 years then every 6-12 months until year 5.
Lead OrganizationUniversity of Maryland/Greenebaum Cancer Center
Principal InvestigatorMatthew Jeffrey Ferris
