RecruitingPhase 2NCT07293247

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)


Sponsor

Alliance for Clinical Trials in Oncology

Enrollment

164 participants

Start Date

Jul 14, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria22

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGChemotherapy

Receive standard of care chemotherapy

OTHERImmunotherapy

Receive standard of care immunotherapy

RADIATIONIntensity-Modulated Radiation Therapy

Undergo I²-PORT

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

OTHERFludeoxyglucose F-18

Undergo FDG PET scan

PROCEDUREBiospecimen Collection

Undergo blood sample collection


Locations(28)

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, 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

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 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

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07293247


Related Trials