A Study of Targeted Post-Surgery Radiation Therapy for Non-Small Cell Lung Cancer With Remaining Lymph Node Cancer After Treatment

Conditions

• Lung Non-Small Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Chemotherapy — DRUG
  Receive standard of care chemotherapy
• Immunotherapy — OTHER
  Receive standard of care immunotherapy
• Intensity-Modulated Radiation Therapy — RADIATION
  Undergo I²-PORT
• Computed Tomography — PROCEDURE
  Undergo CT
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Fludeoxyglucose F-18 — OTHER
  Undergo FDG PET scan
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection

Study Details

This phase II trial compares the effect of intensity-modulated post-operative radiation therapy (I²-PORT) followed by standard of care therapy (chemotherapy or immunotherapy) to standard of care therapy alone in treating patients with non-small cell lung cancer (NSCLC) who have remaining lymph node cancer after surgery. Radiation therapy uses high-energy X-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Intensity-modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Adding I²-PORT radiation therapy to standard therapy may be more effective than standard therapy alone in reducing the risk of cancer returning in those who have undergone surgery for NSCLC.

Key Dates

First listed

Dec 19, 2025

Start date

Oct 14, 2026

Status verified

Sep 2026

Primary completion

Dec 31, 2028

Completion

Mar 1, 2032

Study Design

Enrollment

164 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (SOC chemotherapy/immunotherapy)
  Patients receive SOC chemotherapy or immunotherapy on study. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI, FDG-PET, and blood sample collection throughout the study.
• Experimental: Arm II (I²-PORT, SOC chemotherapy/immunotherapy)
  Patients undergo I²-PORT QD Monday through Friday over 15-25 fractions over 5-6 weeks. Starting 1-42 days after completion of I²-PORT, patients receive SOC chemotherapy or immunotherapy on study. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI, FDG-PET, and blood sample collection throughout the study.

Primary Outcome Measure

Disease-free survival (DFS) [ Time Frame: Time from the date of randomization to the date of earliest disease recurrence/progression or deaths of all causes, assessed up to 5 years ]

Central Contacts

• Amanda Clark
  773-702-9171
  [email protected]

Locations (97)

Find similar trials in Jonesboro, AR

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