A Study Evaluating Neoadjuvant Chemoimmunotherapy With Immunosensitizing Radiation for Borderline Resectable Non-Small Cell Lung Cancer

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT06800339
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    This will be administered intravenously once every 3 weeks for up to 3 cycles (i.e. 9 weeks of total systemic therapy)
  • Chemotherapy — DRUG
    Chemotherapy options include: carboplatin or cisplatin along with pemetrexed, paclitaxel or gemcitabine
  • SBRT — RADIATION
    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
  • Surgical Resection — PROCEDURE
    Post treatment patient will be evaluated for surgical resection

Study Details

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.

Key Dates

Start date
Apr 22, 2025
Status verified
May 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2030

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SBRT+Chemoimmunotherapy +/-Surgery
    Standard of care chemotherapy along with nivolumab. Nivolumab will be infused every 3 weeks for up to 3 cycles. Chemotherapy options include: carboplatin or cisplatin along with pemetrexed, paclitaxel or gemcitabine. Concurrently patient will receive 3 fractions of SBRT. Patient will then be evaluated for possible surgical resection.

Primary Outcome Measure

Tolerability of Adding Sub-ablative, Immunosensitizing, Radiotherapy to Standard of Care Neoadjuvant Chemoimmunotherapy [ Time Frame: 20 weeks post initiation of neoadjuvant therapy ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Maryland Proton Treatment CenterBaltimoreMaryland21201
Caitlin Eggleston, MPH
[email protected]
4103287586
University of Maryland Greenebaum Cancer CenterBaltimoreMaryland21201
Caitlin Eggleston, MPH
[email protected]
4103287586
Upper Chesapeake- Kaufman Cancer CenterBel AirMaryland21014
Lalicia Roman
[email protected]
443-643-1877
Baltimore Washington Medical Center- Tate Cancer CenterGlen BurnieMaryland21061
Pilar Strycula
[email protected]
410-553-8110

Find similar trials in Baltimore, MD

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Maryland Proton Treatment Center· Baltimore, MDUniversity of Maryland Greenebaum Cancer Center· Baltimore, MDUpper Chesapeake- Kaufman Cancer Center· Bel Air, MDBaltimore Washington Medical Center- Tate Cancer Center· Glen Burnie, MD

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