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.
Histopathologic diagnosis of NSCLC, may have mixed or multiple histologies but no small cell component
No known EGFR mutation or ALK rearrangement
No metastatic disease (M0) per most recent PET/CT and head CT/MRI imaging
No disease progression per CT chest (including upper abdomen as per standard practice) with intravenous (IV) contrast (unless IV contrast is contraindicated) or FDG-PET performed post-neoadjuvant therapy ≤ 90 days prior to registration, either before or after surgery
None
Parallel
Chemotherapy
DrugReceive standard of care chemotherapy
Immunotherapy
Other interventionReceive standard of care immunotherapy
Intensity-Modulated Radiation Therapy
RadiationUndergo I²-PORT
Computed Tomography
Procedure/SurgeryUndergo CT
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Fludeoxyglucose F-18
Other interventionUndergo FDG PET scan
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Disease-free survival (DFS)
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 toxicities
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.
5-year DFS
DFS will be analyzed using the Kaplan-Meier methodology and compared between Arm 2 and Arm 1
2-year overall survival (OS)
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. Multivariable Cox models will evaluate the treatment effect on survival time and its interaction with baseline covariates, including stage, pre-treatment, histology, and performance status.
5-year OS
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. Multivariable Cox models will evaluate the treatment effect on survival time and its interaction with baseline covariates, including stage, pre-treatment, histology, and performance status.
Patient-reported symptoms
Will be assessed using Patient Reported Outcomes - Common Terminology Criteria for Adverse Events and will be evaluated for between-arm differences in proportions of patients with a maximum post-baseline score greater than 0 using Fisher's exact or chi-square test.
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Alliance for Clinical Trials in Oncology
Lead sponsor
National Cancer Institute (NCI)
Collaborator