Targeted Radiation After Surgery for Non-Small Cell Lung Cancer
This study is looking at whether a special type of radiation therapy, called Intensity-Modulated Radiation Therapy (I²-PORT), can help patients with non-small cell lung cancer (NSCLC) who still have cancer in their lymph nodes after surgery. You would either receive I²-PORT followed by standard care (chemotherapy or immunotherapy), or standard care alone. Researchers want to see if I²-PORT improves how long patients live without their cancer returning (disease-free survival) and if it causes any serious heart or lung problems. To join, you must have NSCLC, no known EGFR or ALK gene changes, and no cancer spread to other parts of your body. The study is currently unclear on its recruitment status.
- Study design
- This is an interventional study that plans to enroll 164 participants. Participants will be randomly assigned to one of two groups.
- What's involved
- Participants will undergo procedures like Computed Tomography (CT) and Magnetic Resonance Imaging (MRI). Treatment continues in the absence of disease progression or unacceptable toxicity.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your disease-free survival will be assessed for up to 5 years. Serious heart and lung side effects will be monitored between 3 and 24 months after treatment.
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A Study of Targeted Post-Surgery Radiation Therapy for Non-Small Cell Lung Cancer With Remaining Lymph Node Cancer After Treatment
At a glance
Conditions
Where it's being run
74 sites across 16 statesStudy leadership
- David Kozono, MD · STUDY_CHAIR · Alliance for Clinical Trials in Oncology
- Jeremy Brownstein, MD · STUDY_CHAIR · Alliance for Clinical Trials in Oncology
Who to contact
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What this trial measures
- Disease-free survival (DFS)Time from the date of randomization to the date of earliest disease recurrence/progression or deaths of all causes, assessed up to 5 years
DFS will be analyzed using the Kaplan-Meier methodology and compared between Arm 2 and Arm 1 using a log-rank test stratified by randomization factors. The median DFS for each treatment group will be estimated, and its 80% and 90% confidence intervals will be calculated using the Kaplan-Meier estimator. Additionally, the 24-month DFS rate for each treatment arm, along with its confidence intervals, will be calculated.
- Incidence of late grade ≥ 3 cardiopulmonary toxicitiesBetween 3 and 24 months after protocol therapy
Will be assessed according to the Common Terminology Criteria for Adverse Events version 5.0. Will be estimated for each treatment group and the difference between the two treatment groups. The confidence intervals of the rate difference at 80% and 90% significance levels will be estimated using the Miettinen-Nurminen method.