NCT07293247RecruitingPhase 2
A Study of Targeted Post-Surgery Radiation Therapy for Non-Small Cell Lung Cancer With Remaining Lymph Node Cancer After Treatment
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)
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 164 (estimated)
- First submitted
- 17 Dec 2025
- Start date
- 14 Oct 2026
- Primary completion date
- 31 Dec 2032
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Diseases
- Lung cancer
- NCT number
- NCT07293247
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 164
- From 14 Oct 2026 to the primary completion date, 31 Dec 2032
- 125 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (125)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Northwest Wisconsin Cancer Center Coordinator of this site? Confirm its status | Ashland | United States | Recruiting |
| Duluth Clinic Ashland Coordinator of this site? Confirm its status | Ashland | United States | Recruiting |
| Mount Sinai Comprehensive Cancer Center at Aventura Coordinator of this site? Confirm its status | Aventura | United States | Recruiting |
| Memorial Sloan Kettering Basking Ridge Coordinator of this site? Confirm its status | Basking Ridge | United States | Recruiting |
| MaineHealth Coastal Cancer Treatment Center Coordinator of this site? Confirm its status | Bath | United States | Recruiting |
| UPMC-Heritage Valley Health System Beaver Coordinator of this site? Confirm its status | Beaver | United States | Recruiting |
| Sanford Joe Lueken Cancer Center Coordinator of this site? Confirm its status | Bemidji | United States | Recruiting |
| Sanford Bismarck Medical Center Coordinator of this site? Confirm its status | Bismarck | United States | Recruiting |
| Illinois CancerCare-Bloomington Coordinator of this site? Confirm its status | Bloomington | United States | Recruiting |
| OSF Saint Joseph Medical Center Coordinator of this site? Confirm its status | Bloomington | United States | Recruiting |
| Essentia Health Saint Joseph's Medical Center Coordinator of this site? Confirm its status | Brainerd | United States | Recruiting |
| Trinity Health Medical Center - Brighton Coordinator of this site? Confirm its status | Brighton | United States | Recruiting |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Coordinator of this site? Confirm its status | Brighton | United States | Recruiting |
| MaineHealth Cancer Care and IV Therapy - Brunswick Coordinator of this site? Confirm its status | Brunswick | United States | Recruiting |
| Trinity Health Medical Center - Canton Coordinator of this site? Confirm its status | Canton | United States | Recruiting |
| Illinois CancerCare-Canton Coordinator of this site? Confirm its status | Canton | United States | Recruiting |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Coordinator of this site? Confirm its status | Canton | United States | Recruiting |
| Saint Francis Medical Center Coordinator of this site? Confirm its status | Cape Girardeau | United States | Recruiting |
| Carlisle Regional Cancer Center Coordinator of this site? Confirm its status | Carlisle | United States | Recruiting |
| Illinois CancerCare-Carthage Coordinator of this site? Confirm its status | Carthage | United States | Recruiting |
| UNC Lineberger Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Chelsea Hospital Coordinator of this site? Confirm its status | Chelsea | United States | Recruiting |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Coordinator of this site? Confirm its status | Chelsea | United States | Recruiting |
| Rush MD Anderson Cancer Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Clackamas Radiation Oncology Center Coordinator of this site? Confirm its status | Clackamas | United States | Recruiting |
| Baptist Memorial Hospital and Cancer Center-Collierville Coordinator of this site? Confirm its status | Collierville | United States | Recruiting |
| Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Memorial Sloan Kettering Commack Coordinator of this site? Confirm its status | Commack | United States | Recruiting |
| Cancer Care Specialists of Illinois - Decatur Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
| Decatur Memorial Hospital Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
| Essentia Health - Deer River Clinic Coordinator of this site? Confirm its status | Deer River | United States | Recruiting |
| Miller-Dwan Hospital Coordinator of this site? Confirm its status | Duluth | United States | Recruiting |
| Essentia Health Saint Mary's Medical Center Coordinator of this site? Confirm its status | Duluth | United States | Recruiting |
| Essentia Health Cancer Center Coordinator of this site? Confirm its status | Duluth | United States | Recruiting |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Marshfield Medical Center-EC Cancer Center Coordinator of this site? Confirm its status | Eau Claire | United States | Recruiting |
| UPMC Hillman Cancer Center Erie Coordinator of this site? Confirm its status | Erie | United States | Recruiting |
| Illinois CancerCare-Eureka Coordinator of this site? Confirm its status | Eureka | United States | Recruiting |
| Sanford Broadway Medical Center Coordinator of this site? Confirm its status | Fargo | United States | Recruiting |
| Sanford Roger Maris Cancer Center Coordinator of this site? Confirm its status | Fargo | United States | Recruiting |
| Parkland Health Center - Farmington Coordinator of this site? Confirm its status | Farmington | United States | Suspended |
| UPMC Cancer Center at UPMC Horizon Coordinator of this site? Confirm its status | Farrell | United States | Recruiting |
| Illinois CancerCare-Galesburg Coordinator of this site? Confirm its status | Galesburg | United States | Recruiting |
| UPMC Cancer Centers - Arnold Palmer Pavilion Coordinator of this site? Confirm its status | Greensburg | United States | Recruiting |
| UPMC Pinnacle Cancer Center/Community Osteopathic Campus Coordinator of this site? Confirm its status | Harrisburg | United States | Recruiting |
| Memorial Sloan Kettering Westchester Coordinator of this site? Confirm its status | Harrison | United States | Recruiting |
| Essentia Health-Hayward Clinic Coordinator of this site? Confirm its status | Hayward | United States | Recruiting |
| Essentia Health Hibbing Clinic Coordinator of this site? Confirm its status | Hibbing | United States | Recruiting |
| IRMC Cancer Center Coordinator of this site? Confirm its status | Indiana | United States | Recruiting |
| Baptist MD Anderson Cancer Center Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Coordinator of this site? Confirm its status | Jonesboro | United States | Recruiting |
| Bronson Methodist Hospital Coordinator of this site? Confirm its status | Kalamazoo | United States | Recruiting |
| West Michigan Cancer Center Coordinator of this site? Confirm its status | Kalamazoo | United States | Recruiting |
| Beacon Kalamazoo Coordinator of this site? Confirm its status | Kalamazoo | United States | Recruiting |
| Illinois CancerCare-Kewanee Clinic Coordinator of this site? Confirm its status | Kewanee | United States | Recruiting |
| Trinity Health Saint Mary Mercy Livonia Hospital Coordinator of this site? Confirm its status | Livonia | United States | Recruiting |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Illinois CancerCare-Macomb Coordinator of this site? Confirm its status | Macomb | United States | Recruiting |
| Marshfield Medical Center-Marshfield Coordinator of this site? Confirm its status | Marshfield | United States | Recruiting |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Coordinator of this site? Confirm its status | Mechanicsburg | United States | Recruiting |
| Baptist Memorial Hospital and Cancer Center-Memphis Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
| Mount Sinai Medical Center Coordinator of this site? Confirm its status | Miami Beach | United States | Recruiting |
| Memorial Sloan Kettering Monmouth Coordinator of this site? Confirm its status | Middletown | United States | Recruiting |
| UPMC Hillman Cancer Center - Monroeville Coordinator of this site? Confirm its status | Monroeville | United States | Recruiting |
| UPMC Cancer Center - Monroeville Coordinator of this site? Confirm its status | Monroeville | United States | Recruiting |
| Memorial Sloan Kettering Bergen Coordinator of this site? Confirm its status | Montvale | United States | Recruiting |
| Providence Newberg Medical Center Coordinator of this site? Confirm its status | Newberg | United States | Recruiting |
| UPMC Hillman Cancer Center - New Castle Coordinator of this site? Confirm its status | New Castle | United States | Recruiting |
| New York Proton Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Arnold Palmer Cancer Center Medical Oncology Norwin Coordinator of this site? Confirm its status | N. Huntingdon | United States | Recruiting |
| HSHS Saint Elizabeth's Hospital Coordinator of this site? Confirm its status | O'Fallon | United States | Recruiting |
| Cancer Care Center of O'Fallon Coordinator of this site? Confirm its status | O'Fallon | United States | Recruiting |
| Providence Willamette Falls Medical Center Coordinator of this site? Confirm its status | Oregon City | United States | Recruiting |
| Upstate Cancer Center Radiation Oncology at Oswego Coordinator of this site? Confirm its status | Oswego | United States | Recruiting |
| Upstate Cancer Center at Oswego Coordinator of this site? Confirm its status | Oswego | United States | Recruiting |
| Illinois CancerCare-Ottawa Clinic Coordinator of this site? Confirm its status | Ottawa | United States | Recruiting |
| Baptist Memorial Hospital and Cancer Center-Oxford Coordinator of this site? Confirm its status | Oxford | United States | Recruiting |
| AdventHealth Parker Coordinator of this site? Confirm its status | Parker | United States | Recruiting |
| OSF Saint Francis Radiation Oncology at Pekin Coordinator of this site? Confirm its status | Pekin | United States | Recruiting |
| Illinois CancerCare-Pekin Coordinator of this site? Confirm its status | Pekin | United States | Recruiting |
| Illinois CancerCare-Peoria Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
| OSF Saint Francis Radiation Oncology at Peoria Cancer Center Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
| OSF Saint Francis Medical Center Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
| Illinois CancerCare-Peru Coordinator of this site? Confirm its status | Peru | United States | Recruiting |
| UPMC-Saint Margaret Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| UPMC Hillman Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| UPMC-Saint Clair Hospital Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| UPMC-Shadyside Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| UPMC-Passavant Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Providence Saint Vincent Medical Center Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Providence Portland Medical Center Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| MaineHealth Maine Medical Center - Portland Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Illinois CancerCare-Princeton Coordinator of this site? Confirm its status | Princeton | United States | Recruiting |
| Marshfield Medical Center-Rice Lake Coordinator of this site? Confirm its status | Rice Lake | United States | Recruiting |
| Sainte Genevieve County Memorial Hospital Coordinator of this site? Confirm its status | Sainte Genevieve | United States | Suspended |
| Essentia Health Sandstone Coordinator of this site? Confirm its status | Sandstone | United States | Recruiting |
| MaineHealth Cancer Care Center of York County Coordinator of this site? Confirm its status | Sanford | United States | Recruiting |
| MaineHealth Maine Medical Center- Scarborough Coordinator of this site? Confirm its status | Scarborough | United States | Recruiting |
| UPMC Cancer Center at UPMC Northwest Coordinator of this site? Confirm its status | Seneca | United States | Recruiting |
| Sanford Cancer Center Oncology Clinic Coordinator of this site? Confirm its status | Sioux Falls | United States | Recruiting |
| Sanford USD Medical Center - Sioux Falls Coordinator of this site? Confirm its status | Sioux Falls | United States | Recruiting |
| Baptist Memorial Hospital and Cancer Center-Desoto Coordinator of this site? Confirm its status | Southhaven | United States | Recruiting |
| MaineHealth Cancer Care and IV Therapy - South Portland Coordinator of this site? Confirm its status | South Portland | United States | Recruiting |
| Essentia Health-Spooner Clinic Coordinator of this site? Confirm its status | Spooner | United States | Recruiting |
| Marshfield Medical Center-River Region at Stevens Point Coordinator of this site? Confirm its status | Stevens Point | United States | Recruiting |
| Missouri Baptist Medical Center Coordinator of this site? Confirm its status | St Louis | United States | Suspended |
| Missouri Baptist Sullivan Hospital Coordinator of this site? Confirm its status | Sullivan | United States | Suspended |
| Essentia Health Saint Mary's Hospital - Superior Coordinator of this site? Confirm its status | Superior | United States | Recruiting |
| Upstate Cancer Center at Hill Radiation Oncology Coordinator of this site? Confirm its status | Syracuse | United States | Recruiting |
| State University of New York Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Recruiting |
| Montefiore Medical Center - Moses Campus Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Montefiore Medical Center-Einstein Campus Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Munson Medical Center Coordinator of this site? Confirm its status | Traverse City | United States | Recruiting |
| Memorial Sloan Kettering Nassau Coordinator of this site? Confirm its status | Uniondale | United States | Recruiting |
| Upstate Cancer Center at Verona Coordinator of this site? Confirm its status | Verona | United States | Recruiting |
| Essentia Health Virginia Clinic Coordinator of this site? Confirm its status | Virginia | United States | Recruiting |
| UPMC Cancer Center-Washington Coordinator of this site? Confirm its status | Washington | United States | Recruiting |
| Illinois CancerCare - Washington Coordinator of this site? Confirm its status | Washington | United States | Recruiting |
| UPMC Washington Hospital Radiation Oncology Coordinator of this site? Confirm its status | Washington | United States | Recruiting |
| Marshfield Medical Center - Weston Coordinator of this site? Confirm its status | Weston | United States | Recruiting |
| Ascension Via Christi Hospitals Wichita Coordinator of this site? Confirm its status | Wichita | United States | Recruiting |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Coordinator of this site? Confirm its status | Ypsilanti | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.