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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Alliance for Clinical Trials in Oncology • ClinicalTrials.gov ID: NCT07293247

Registry updated: 2026-10-19
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Description

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.

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

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

Conditions

Lung Non-Small Cell Carcinoma

Locations

  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas, United States
  • USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
  • AdventHealth Parker — Parker, Colorado, United States
  • OSF Saint Joseph Medical Center — Bloomington, Illinois, United States
  • Illinois CancerCare-Bloomington — Bloomington, Illinois, United States
  • Illinois CancerCare-Canton — Canton, Illinois, United States
  • Illinois CancerCare-Carthage — Carthage, Illinois, United States
  • Rush MD Anderson Cancer Center — Chicago, Illinois, United States
  • Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois, United States
  • Decatur Memorial Hospital — Decatur, Illinois, United States
  • Illinois CancerCare-Eureka — Eureka, Illinois, United States
  • Illinois CancerCare-Galesburg — Galesburg, Illinois, United States
  • Illinois CancerCare-Kewanee Clinic — Kewanee, Illinois, United States
  • Illinois CancerCare-Macomb — Macomb, Illinois, United States
  • Cancer Care Center of O'Fallon — O'Fallon, Illinois, United States
  • HSHS Saint Elizabeth's Hospital — O'Fallon, Illinois, United States
  • Illinois CancerCare-Ottawa Clinic — Ottawa, Illinois, United States
  • Illinois CancerCare-Pekin — Pekin, Illinois, United States
  • OSF Saint Francis Radiation Oncology at Pekin — Pekin, Illinois, United States
  • Illinois CancerCare-Peoria — Peoria, Illinois, United States
  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center — Peoria, Illinois, United States
  • OSF Saint Francis Medical Center — Peoria, Illinois, United States
  • Illinois CancerCare-Peru — Peru, Illinois, United States
  • Illinois CancerCare-Princeton — Princeton, Illinois, United States
  • Illinois CancerCare - Washington — Washington, Illinois, United States
  • Ascension Via Christi Hospitals Wichita — Wichita, Kansas, United States
  • MaineHealth Coastal Cancer Treatment Center — Bath, Maine, United States
  • MaineHealth Cancer Care and IV Therapy - Brunswick — Brunswick, Maine, United States
  • MaineHealth Maine Medical Center - Portland — Portland, Maine, United States
  • MaineHealth Cancer Care Center of York County — Sanford, Maine, United States
  • MaineHealth Maine Medical Center- Scarborough — Scarborough, Maine, United States
  • MaineHealth Cancer Care and IV Therapy - South Portland — South Portland, Maine, United States
  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor — Ann Arbor, Michigan, United States
  • Trinity Health IHA Medical Group Hematology Oncology - Brighton — Brighton, Michigan, United States
  • Trinity Health Medical Center - Brighton — Brighton, Michigan, United States
  • Trinity Health IHA Medical Group Hematology Oncology - Canton — Canton, Michigan, United States
  • Trinity Health Medical Center - Canton — Canton, Michigan, United States
  • Chelsea Hospital — Chelsea, Michigan, United States
  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital — Chelsea, Michigan, United States
  • Trinity Health Saint Mary Mercy Livonia Hospital — Livonia, Michigan, United States
  • Munson Medical Center — Traverse City, Michigan, United States
  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus — Ypsilanti, Michigan, United States
  • Sanford Joe Lueken Cancer Center — Bemidji, Minnesota, United States
  • Essentia Health Saint Joseph's Medical Center — Brainerd, Minnesota, United States
  • Essentia Health - Deer River Clinic — Deer River, Minnesota, United States
  • Essentia Health Cancer Center — Duluth, Minnesota, United States
  • Essentia Health Saint Mary's Medical Center — Duluth, Minnesota, United States
  • Miller-Dwan Hospital — Duluth, Minnesota, United States
  • Essentia Health Hibbing Clinic — Hibbing, Minnesota, United States
  • Essentia Health Sandstone — Sandstone, Minnesota, United States
  • Essentia Health Virginia Clinic — Virginia, Minnesota, United States
  • Baptist Memorial Hospital and Cancer Center-Desoto — Southhaven, Mississippi, United States
  • Saint Francis Medical Center — Cape Girardeau, Missouri, United States
  • Parkland Health Center - Farmington — Farmington, Missouri, United States
  • Sainte Genevieve County Memorial Hospital — Sainte Genevieve, Missouri, United States
  • Missouri Baptist Medical Center — St Louis, Missouri, United States
  • Missouri Baptist Sullivan Hospital — Sullivan, Missouri, United States
  • Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
  • Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
  • Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
  • Memorial Sloan Kettering Commack — Commack, New York, United States
  • Memorial Sloan Kettering Westchester — Harrison, New York, United States
  • New York Proton Center — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • Upstate Cancer Center at Oswego — Oswego, New York, United States
  • Upstate Cancer Center Radiation Oncology at Oswego — Oswego, New York, United States
  • State University of New York Upstate Medical University — Syracuse, New York, United States
  • Upstate Cancer Center at Hill Radiation Oncology — Syracuse, New York, United States
  • Montefiore Medical Center-Einstein Campus — The Bronx, New York, United States
  • Montefiore Medical Center - Moses Campus — The Bronx, New York, United States
  • Memorial Sloan Kettering Nassau — Uniondale, New York, United States
  • Upstate Cancer Center at Verona — Verona, New York, United States
  • UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
  • Sanford Bismarck Medical Center — Bismarck, North Dakota, United States
  • Sanford Broadway Medical Center — Fargo, North Dakota, United States
  • Sanford Roger Maris Cancer Center — Fargo, North Dakota, United States
  • Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
  • Clackamas Radiation Oncology Center — Clackamas, Oregon, United States
  • Providence Newberg Medical Center — Newberg, Oregon, United States
  • Providence Willamette Falls Medical Center — Oregon City, Oregon, United States
  • Providence Portland Medical Center — Portland, Oregon, United States
  • Providence Saint Vincent Medical Center — Portland, Oregon, United States
  • UPMC-Heritage Valley Health System Beaver — Beaver, Pennsylvania, United States
  • Carlisle Regional Cancer Center — Carlisle, Pennsylvania, United States
  • UPMC Hillman Cancer Center Erie — Erie, Pennsylvania, United States
  • UPMC Cancer Center at UPMC Horizon — Farrell, Pennsylvania, United States
  • UPMC Cancer Centers - Arnold Palmer Pavilion — Greensburg, Pennsylvania, United States
  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus — Harrisburg, Pennsylvania, United States
  • IRMC Cancer Center — Indiana, Pennsylvania, United States
  • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion — Mechanicsburg, Pennsylvania, United States
  • UPMC Cancer Center - Monroeville — Monroeville, Pennsylvania, United States
  • UPMC Hillman Cancer Center - Monroeville — Monroeville, Pennsylvania, United States
  • Arnold Palmer Cancer Center Medical Oncology Norwin — N. Huntingdon, Pennsylvania, United States
  • UPMC Hillman Cancer Center - New Castle — New Castle, Pennsylvania, United States
  • UPMC-Saint Margaret — Pittsburgh, Pennsylvania, United States
  • UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
  • UPMC-Shadyside Hospital — Pittsburgh, Pennsylvania, United States
  • UPMC-Passavant Hospital — Pittsburgh, Pennsylvania, United States
  • UPMC-Saint Clair Hospital Cancer Center — Pittsburgh, Pennsylvania, United States
  • UPMC Cancer Center at UPMC Northwest — Seneca, Pennsylvania, United States
  • UPMC Cancer Center-Washington — Washington, Pennsylvania, United States
  • UPMC Washington Hospital Radiation Oncology — Washington, Pennsylvania, United States
  • Sanford Cancer Center Oncology Clinic — Sioux Falls, South Dakota, United States
  • Sanford USD Medical Center - Sioux Falls — Sioux Falls, South Dakota, United States
  • Baptist Memorial Hospital and Cancer Center-Collierville — Collierville, Tennessee, United States
  • Baptist Memorial Hospital and Cancer Center-Memphis — Memphis, Tennessee, United States
  • Duluth Clinic Ashland — Ashland, Wisconsin, United States
  • Northwest Wisconsin Cancer Center — Ashland, Wisconsin, United States
  • Essentia Health-Hayward Clinic — Hayward, Wisconsin, United States
  • Essentia Health-Spooner Clinic — Spooner, Wisconsin, United States
  • Essentia Health Saint Mary's Hospital - Superior — Superior, Wisconsin, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record