A Study Evaluating Neoadjuvant Chemoimmunotherapy With Immunosensitizing Radiation for Bor
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 th
| Condition(s) | Non-Small Cell Lung Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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 nivoluma |
| Who can participate | Inclusion Criteria: 1. Age greater than or equal to18 years at time of study entry 2. Eastern cooperative oncology group (ECOG) performance status of 0 or 1 3. Participants with histologically confirmed stage II-IIIC(N3) NSCLC (per the 8th International Association for the Study of Lung Cancer) with disease that is considered borderline resectable prior to initiation of RT or systemic therapy. a. Patients with intrathoracic, contralateral N3 disease will be allowed to enroll (see exclusion criteria for further details) 4. Subject cases must be reviewed in a multidisciplinary thoracic tumor board setting prior to enrollment to allow for adequate discussion regarding the potential for resection. 5. Participants must have a tumor tissue sample available for biomarker testing, including next-g |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Maryland, Baltimore |
| Locations | Baltimore, Maryland, United States; Baltimore, Maryland, United States; Bel Air, Maryland, United States; Glen Burnie, Maryland, United States |
| Start date | 2025-04-22 |
| NCT ID | NCT06800339 |
| Official listing | https://clinicaltrials.gov/study/NCT06800339 |