Home › Non-Small Cell Lung Cancer › NCT07293247
A Study of Targeted Post-Surgery Radiation Therapy for Non-Small Cell Lung Cancer With Remaining Lymph Node Cancer After Treatment
RecruitingPhase 2
Involved-Station, Intensity-Modulated Post-Operative Radiation Therapy (I²-PORT) for Resected Non-Small Cell Lung Cancer With Residual Mediastinal Adenopathy After Neoadjuvant Therapy (ypN2)
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
* 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
* No metastatic disease (M0) per head CT/MRI imaging
* Prior treatment with 2-4 cycles of neoadjuvant systemic therapy with any guideline (National Comprehensive Cancer Network \[NCCN\]) concordant regimen
* Lobectomy or greater oncologic surgical resection within 8 weeks prior to registration
* Complete (R0) resection showing ypN2 disease
* No prior radiotherapy to the lungs or mediastinum
* No treatment with a VEGF inhibitor ≤ 90 days prior to registration or plan to treat with adjuvant systemic therapy including a VEGF inhibitor
* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Absolute neutrophil count (ANC) ≥ 1,000/mm\^3
* Platelet count ≥ 50,000/mm\^3
* Calculated (Calc.) creatinine clearance ≥ 30 mL/min
* Total bilirubin ≤ 3 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 5 x upper limit of normal (ULN)
* Not pregnant, because this study involves radiation therapy, which has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 7 days prior to registration is required
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Cardiac function: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
* No idiopathic pulmonary fibrosis requiring anti-fibrotic medication: Patients with idiopathic pulmonary fibrosis or inflammatory/interstitial lung disease compromising pulmonary function or requiring ongoing treatment with nintedanib, pirfenidone, or other anti-fibrotic drug are excluded
* HIV-infected patients on effective anti-retroviral therapy with an undetectable viral load within 6 months are eligible for this trial
About the study
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.
What is being tested
- Chemotherapy (drug)
- Immunotherapy (other)
- Intensity-Modulated Radiation Therapy (radiation)
- Computed Tomography (procedure)
- Magnetic Resonance Imaging (procedure)
- Fludeoxyglucose F-18 (other)
Sponsor: Alliance for Clinical Trials in Oncology · Participants: 164 · Started: Oct 14, 2026
Contact the study team
Official record on ClinicalTrials.gov — NCT07293247
Locations in the U.S.
| Arkansas | NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro, Jonesboro |
| California | USC / Norris Comprehensive Cancer Center, Los Angeles |
| Colorado | AdventHealth Parker, Parker |
| Florida | Mount Sinai Comprehensive Cancer Center at Aventura, Aventura Baptist MD Anderson Cancer Center, Jacksonville Mount Sinai Medical Center, Miami Beach |
| Illinois | Illinois CancerCare-Bloomington, Bloomington OSF Saint Joseph Medical Center, Bloomington Illinois CancerCare-Canton, Canton Illinois CancerCare-Carthage, Carthage Rush MD Anderson Cancer Center, Chicago Cancer Care Specialists of Illinois - Decatur, Decatur Decatur Memorial Hospital, Decatur Illinois CancerCare-Eureka, Eureka Illinois CancerCare-Galesburg, Galesburg Illinois CancerCare-Kewanee Clinic, Kewanee Illinois CancerCare-Macomb, Macomb Cancer Care Center of O'Fallon, O'Fallon HSHS Saint Elizabeth's Hospital, O'Fallon Illinois CancerCare-Ottawa Clinic, Ottawa Illinois CancerCare-Pekin, Pekin OSF Saint Francis Radiation Oncology at Pekin, Pekin Illinois CancerCare-Peoria, Peoria OSF Saint Francis Medical Center, Peoria OSF Saint Francis Radiation Oncology at Peoria Cancer Center, Peoria Illinois CancerCare-Peru, Peru Illinois CancerCare-Princeton, Princeton Illinois CancerCare - Washington, Washington |
| Kansas | Ascension Via Christi Hospitals Wichita, Wichita |
| Maine | MaineHealth Coastal Cancer Treatment Center, Bath MaineHealth Cancer Care and IV Therapy - Brunswick, Brunswick MaineHealth Maine Medical Center - Portland, Portland MaineHealth Cancer Care Center of York County, Sanford MaineHealth Maine Medical Center- Scarborough, Scarborough MaineHealth Cancer Care and IV Therapy - South Portland, South Portland |
| Michigan | Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton Trinity Health Medical Center - Brighton, Brighton Trinity Health IHA Medical Group Hematology Oncology - Canton, Canton Trinity Health Medical Center - Canton, Canton Chelsea Hospital, Chelsea Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea Beacon Kalamazoo, Kalamazoo Bronson Methodist Hospital, Kalamazoo West Michigan Cancer Center, Kalamazoo Trinity Health Saint Mary Mercy Livonia Hospital, Livonia Munson Medical Center, Traverse City Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti |
| Minnesota | Sanford Joe Lueken Cancer Center, Bemidji Essentia Health Saint Joseph's Medical Center, Brainerd Essentia Health - Deer River Clinic, Deer River Essentia Health Cancer Center, Duluth Essentia Health Saint Mary's Medical Center, Duluth Miller-Dwan Hospital, Duluth Essentia Health Hibbing Clinic, Hibbing Essentia Health Sandstone, Sandstone Essentia Health Virginia Clinic, Virginia |
| Mississippi | Baptist Memorial Hospital and Cancer Center-Oxford, Oxford Baptist Memorial Hospital and Cancer Center-Desoto, Southhaven |
| Missouri | Saint Francis Medical Center, Cape Girardeau |
| New Jersey | Memorial Sloan Kettering Basking Ridge, Basking Ridge Memorial Sloan Kettering Monmouth, Middletown Memorial Sloan Kettering Bergen, Montvale |
| New York | Memorial Sloan Kettering Commack, Commack Memorial Sloan Kettering Westchester, Harrison Memorial Sloan Kettering Cancer Center, New York New York Proton Center, New York Upstate Cancer Center Radiation Oncology at Oswego, Oswego Upstate Cancer Center at Oswego, Oswego State University of New York Upstate Medical University, Syracuse Upstate Cancer Center at Hill Radiation Oncology, Syracuse Montefiore Medical Center - Moses Campus, The Bronx Montefiore Medical Center-Einstein Campus, The Bronx Memorial Sloan Kettering Nassau, Uniondale Upstate Cancer Center at Verona, Verona |
| North Carolina | UNC Lineberger Comprehensive Cancer Center, Chapel Hill Duke University Medical Center, Durham |
| North Dakota | Sanford Bismarck Medical Center, Bismarck Sanford Broadway Medical Center, Fargo Sanford Roger Maris Cancer Center, Fargo |
| Ohio | Ohio State University Comprehensive Cancer Center, Columbus |
| Oregon | Clackamas Radiation Oncology Center, Clackamas Providence Newberg Medical Center, Newberg Providence Willamette Falls Medical Center, Oregon City Providence Portland Medical Center, Portland Providence Saint Vincent Medical Center, Portland |
| Pennsylvania | UPMC-Heritage Valley Health System Beaver, Beaver Carlisle Regional Cancer Center, Carlisle UPMC Hillman Cancer Center Erie, Erie UPMC Cancer Center at UPMC Horizon, Farrell UPMC Cancer Centers - Arnold Palmer Pavilion, Greensburg UPMC Pinnacle Cancer Center/Community Osteopathic Campus, Harrisburg IRMC Cancer Center, Indiana UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion, Mechanicsburg UPMC Cancer Center - Monroeville, Monroeville UPMC Hillman Cancer Center - Monroeville, Monroeville Arnold Palmer Cancer Center Medical Oncology Norwin, N. Huntingdon UPMC Hillman Cancer Center - New Castle, New Castle UPMC Hillman Cancer Center, Pittsburgh UPMC-Passavant Hospital, Pittsburgh UPMC-Saint Clair Hospital Cancer Center, Pittsburgh UPMC-Saint Margaret, Pittsburgh UPMC-Shadyside Hospital, Pittsburgh UPMC Cancer Center at UPMC Northwest, Seneca UPMC Cancer Center-Washington, Washington UPMC Washington Hospital Radiation Oncology, Washington |
| South Carolina | Medical University of South Carolina, Charleston |
| South Dakota | Sanford Cancer Center Oncology Clinic, Sioux Falls Sanford USD Medical Center - Sioux Falls, Sioux Falls |
| Tennessee | Baptist Memorial Hospital and Cancer Center-Collierville, Collierville Baptist Memorial Hospital and Cancer Center-Memphis, Memphis |
| Wisconsin | Duluth Clinic Ashland, Ashland Northwest Wisconsin Cancer Center, Ashland Marshfield Medical Center-EC Cancer Center, Eau Claire Essentia Health-Hayward Clinic, Hayward Marshfield Medical Center-Marshfield, Marshfield Marshfield Medical Center-Rice Lake, Rice Lake Essentia Health-Spooner Clinic, Spooner Marshfield Medical Center-River Region at Stevens Point, Stevens Point Essentia Health Saint Mary's Hospital - Superior, Superior Marshfield Medical Center - Weston, Weston |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.