Recruiting
Phase 2

I²-PORT & Standard Care

Sponsor:

Alliance for Clinical Trials in Oncology

Code:

NCT07293247

Conditions

Lung Non-Small Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Chemotherapy

Immunotherapy

Intensity-Modulated Radiation Therapy

Computed Tomography

Magnetic Resonance Imaging

Study Details

Brief 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.

Conditions

Lung Non-Small Cell Carcinoma

Study ID

NCT07293247

Start date

Oct 14, 2026

Status verified date

Sep, 2026

Completion date

Mar 1, 2032

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

  • 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

Study Design

Enrollment

164 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm I (SOC chemotherapy/immunotherapy)

Patients receive SOC chemotherapy or immunotherapy on study. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI, FDG-PET, and blood sample collection throughout the study.

experimental: Arm II (I²-PORT, SOC chemotherapy/immunotherapy)

Patients undergo I²-PORT QD Monday through Friday over 15-25 fractions over 5-6 weeks. Starting 1-42 days after completion of I²-PORT, patients receive SOC chemotherapy or immunotherapy on study. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI, FDG-PET, and blood sample collection throughout the study.

Interventions

Chemotherapy

Receive standard of care chemotherapy

Immunotherapy

Receive standard of care immunotherapy

Intensity-Modulated Radiation Therapy

Undergo I²-PORT

Computed Tomography

Undergo CT

Magnetic Resonance Imaging

Undergo MRI

Fludeoxyglucose F-18

Undergo FDG PET scan

Biospecimen Collection

Undergo blood sample collection

Primary outcome measure

  • Disease-free survival (DFS) [ Time Frame: Time from the date of randomization to the date of earliest disease recurrence/progression or deaths of all causes, assessed up to 5 years ]
  • Incidence of late grade ≥ 3 cardiopulmonary toxicities [ Time Frame: Between 3 and 24 months after protocol therapy ]

Central Contacts and Locations

Locations

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Recruiting

Jonesboro, Arkansas, United States, 72401

Contacts

Principal Investigator:

Shelby Lane

USC / Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Site Public Contact

323-865-0451

Principal Investigator:

Joshua P. Schiff

OSF Saint Joseph Medical Center

Recruiting

Bloomington, Illinois, United States, 61701

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Bloomington

Recruiting

Bloomington, Illinois, United States, 61704

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Canton

Recruiting

Canton, Illinois, United States, 61520

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Carthage

Recruiting

Carthage, Illinois, United States, 62321

Contacts

Principal Investigator:

Bryan A. Faller

Rush MD Anderson Cancer Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Principal Investigator:

Gaurav Marwaha

Cancer Care Specialists of Illinois - Decatur

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Principal Investigator:

Bryan A. Faller

Decatur Memorial Hospital

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Eureka

Recruiting

Eureka, Illinois, United States, 61530

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Galesburg

Recruiting

Galesburg, Illinois, United States, 61401

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Kewanee Clinic

Recruiting

Kewanee, Illinois, United States, 61443

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Macomb

Recruiting

Macomb, Illinois, United States, 61455

Contacts

Principal Investigator:

Bryan A. Faller

Cancer Care Center of O'Fallon

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Principal Investigator:

Bryan A. Faller

HSHS Saint Elizabeth's Hospital

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Ottawa Clinic

Recruiting

Ottawa, Illinois, United States, 61350

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Pekin

Recruiting

Pekin, Illinois, United States, 61554

Contacts

Principal Investigator:

Bryan A. Faller

OSF Saint Francis Radiation Oncology at Pekin

Recruiting

Pekin, Illinois, United States, 61554

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Peoria

Recruiting

Peoria, Illinois, United States, 61615

Contacts

Principal Investigator:

Bryan A. Faller

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Recruiting

Peoria, Illinois, United States, 61615

Contacts

Principal Investigator:

Bryan A. Faller

OSF Saint Francis Medical Center

Recruiting

Peoria, Illinois, United States, 61637

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Peru

Recruiting

Peru, Illinois, United States, 61354

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Princeton

Recruiting

Princeton, Illinois, United States, 61356

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare - Washington

Recruiting

Washington, Illinois, United States, 61571

Contacts

Principal Investigator:

Bryan A. Faller

MaineHealth Coastal Cancer Treatment Center

Recruiting

Bath, Maine, United States, 04530

Contacts

Principal Investigator:

Matthew D. Cheney

MaineHealth Cancer Care and IV Therapy - Brunswick

Recruiting

Brunswick, Maine, United States, 04011

Contacts

Principal Investigator:

Matthew D. Cheney

MaineHealth Maine Medical Center - Portland

Recruiting

Portland, Maine, United States, 04102

Contacts

Principal Investigator:

Matthew D. Cheney

MaineHealth Cancer Care Center of York County

Recruiting

Sanford, Maine, United States, 04073

Contacts

Site Public Contact

207-459-1600

Principal Investigator:

Matthew D. Cheney

MaineHealth Maine Medical Center- Scarborough

Recruiting

Scarborough, Maine, United States, 04074

Contacts

Principal Investigator:

Matthew D. Cheney

MaineHealth Cancer Care and IV Therapy - South Portland

Recruiting

South Portland, Maine, United States, 04106

Contacts

Principal Investigator:

Matthew D. Cheney

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Recruiting

Ann Arbor, Michigan, United States, 48106

Contacts

Principal Investigator:

Samir Narayan

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Principal Investigator:

Samir Narayan

Trinity Health Medical Center - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Principal Investigator:

Samir Narayan

Trinity Health IHA Medical Group Hematology Oncology - Canton

Recruiting

Canton, Michigan, United States, 48188

Contacts

Principal Investigator:

Samir Narayan

Trinity Health Medical Center - Canton

Recruiting

Canton, Michigan, United States, 48188

Contacts

Principal Investigator:

Samir Narayan

Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Principal Investigator:

Samir Narayan

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Principal Investigator:

Samir Narayan

Trinity Health Saint Mary Mercy Livonia Hospital

Recruiting

Livonia, Michigan, United States, 48154

Contacts

Principal Investigator:

Samir Narayan

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Principal Investigator:

Samir Narayan

Sanford Joe Lueken Cancer Center

Recruiting

Bemidji, Minnesota, United States, 56601

Contacts

Principal Investigator:

Daniel Almquist

Essentia Health Saint Joseph's Medical Center

Recruiting

Brainerd, Minnesota, United States, 56401

Contacts

Principal Investigator:

Bret E. Friday

Essentia Health - Deer River Clinic

Recruiting

Deer River, Minnesota, United States, 56636

Contacts

Principal Investigator:

Bret E. Friday

Essentia Health Cancer Center

Recruiting

Duluth, Minnesota, United States, 55805

Contacts

Principal Investigator:

Bret E. Friday

Essentia Health Saint Mary's Medical Center

Recruiting

Duluth, Minnesota, United States, 55805

Contacts

Principal Investigator:

Bret E. Friday

Miller-Dwan Hospital

Recruiting

Duluth, Minnesota, United States, 55805

Contacts

Principal Investigator:

Bret E. Friday

Essentia Health Hibbing Clinic

Recruiting

Hibbing, Minnesota, United States, 55746

Contacts

Site Public Contact

218-786-3308

Principal Investigator:

Bret E. Friday

Essentia Health Sandstone

Recruiting

Sandstone, Minnesota, United States, 55072

Contacts

Principal Investigator:

Bret E. Friday

Essentia Health Virginia Clinic

Recruiting

Virginia, Minnesota, United States, 55792

Contacts

Principal Investigator:

Bret E. Friday

Baptist Memorial Hospital and Cancer Center-Desoto

Recruiting

Southhaven, Mississippi, United States, 38671

Contacts

Principal Investigator:

Shelby Lane

Saint Francis Medical Center

Recruiting

Cape Girardeau, Missouri, United States, 63703

Contacts

Site Public Contact

573-334-2230sfmc@sfmc.net

Principal Investigator:

Bryan A. Faller

Memorial Sloan Kettering Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Daphna Y. Gelblum

Memorial Sloan Kettering Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Daphna Y. Gelblum

Memorial Sloan Kettering Bergen

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Daphna Y. Gelblum

Memorial Sloan Kettering Commack

Recruiting

Commack, New York, United States, 11725

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Daphna Y. Gelblum

Memorial Sloan Kettering Westchester

Recruiting

Harrison, New York, United States, 10604

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Daphna Y. Gelblum

New York Proton Center

Recruiting

New York, New York, United States, 10035

Contacts

Principal Investigator:

Charles B. Simone

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Daphna Y. Gelblum

Upstate Cancer Center at Oswego

Recruiting

Oswego, New York, United States, 13126

Contacts

Principal Investigator:

Michael D. Mix

Upstate Cancer Center Radiation Oncology at Oswego

Recruiting

Oswego, New York, United States, 13126

Contacts

Principal Investigator:

Michael D. Mix

State University of New York Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

Site Public Contact

315-464-5476

Principal Investigator:

Michael D. Mix

Upstate Cancer Center at Hill Radiation Oncology

Recruiting

Syracuse, New York, United States, 13210

Contacts

Principal Investigator:

Michael D. Mix

Montefiore Medical Center-Einstein Campus

Recruiting

The Bronx, New York, United States, 10461

Contacts

Principal Investigator:

Nitin Ohri

Montefiore Medical Center - Moses Campus

Recruiting

The Bronx, New York, United States, 10467

Contacts

Principal Investigator:

Nitin Ohri

Memorial Sloan Kettering Nassau

Recruiting

Uniondale, New York, United States, 11553

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Daphna Y. Gelblum

Upstate Cancer Center at Verona

Recruiting

Verona, New York, United States, 13478

Contacts

Principal Investigator:

Michael D. Mix

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

Ashley Weiner

Sanford Bismarck Medical Center

Recruiting

Bismarck, North Dakota, United States, 58501

Contacts

Principal Investigator:

Daniel Almquist

Sanford Broadway Medical Center

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Principal Investigator:

Daniel Almquist

Sanford Roger Maris Cancer Center

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Principal Investigator:

Daniel Almquist

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Jeremy Brownstein

UPMC-Heritage Valley Health System Beaver

Recruiting

Beaver, Pennsylvania, United States, 15009

Contacts

Principal Investigator:

Neal McCall

Carlisle Regional Cancer Center

Recruiting

Carlisle, Pennsylvania, United States, 17015

Contacts

Principal Investigator:

Neal McCall

UPMC Hillman Cancer Center Erie

Recruiting

Erie, Pennsylvania, United States, 16505

Contacts

Principal Investigator:

Neal McCall

UPMC Cancer Center at UPMC Horizon

Recruiting

Farrell, Pennsylvania, United States, 16121

Contacts

Principal Investigator:

Neal McCall

UPMC Cancer Centers - Arnold Palmer Pavilion

Recruiting

Greensburg, Pennsylvania, United States, 15601

Contacts

Site Public Contact

724-838-1900

Principal Investigator:

Neal McCall

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Recruiting

Harrisburg, Pennsylvania, United States, 17109

Contacts

Principal Investigator:

Neal McCall

IRMC Cancer Center

Recruiting

Indiana, Pennsylvania, United States, 15701

Contacts

Principal Investigator:

Neal McCall

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Recruiting

Mechanicsburg, Pennsylvania, United States, 17050

Contacts

Principal Investigator:

Neal McCall

Arnold Palmer Cancer Center Medical Oncology Norwin

Recruiting

N. Huntingdon, Pennsylvania, United States, 15642

Contacts

Principal Investigator:

Neal McCall

UPMC Hillman Cancer Center - New Castle

Recruiting

New Castle, Pennsylvania, United States, 16105

Contacts

Principal Investigator:

Neal McCall

UPMC-Saint Margaret

Recruiting

Pittsburgh, Pennsylvania, United States, 15215

Contacts

Site Public Contact

412-784-4900

Principal Investigator:

Neal McCall

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Site Public Contact

412-647-8073

Principal Investigator:

Neal McCall

UPMC-Shadyside Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Site Public Contact

412-621-2334

Principal Investigator:

Neal McCall

UPMC-Passavant Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15237

Contacts

Site Public Contact

412-367-6454

Principal Investigator:

Neal McCall

UPMC-Saint Clair Hospital Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15243

Contacts

Site Public Contact

412-502-3920

Principal Investigator:

Neal McCall

UPMC Cancer Center at UPMC Northwest

Recruiting

Seneca, Pennsylvania, United States, 16346

Contacts

Site Public Contact

814-676-7900

Principal Investigator:

Neal McCall

UPMC Cancer Center-Washington

Recruiting

Washington, Pennsylvania, United States, 15301

Contacts

Principal Investigator:

Neal McCall

UPMC Washington Hospital Radiation Oncology

Recruiting

Washington, Pennsylvania, United States, 15301

Contacts

Principal Investigator:

Neal McCall

Sanford Cancer Center Oncology Clinic

Recruiting

Sioux Falls, South Dakota, United States, 57104

Contacts

Principal Investigator:

Daniel Almquist

Sanford USD Medical Center - Sioux Falls

Recruiting

Sioux Falls, South Dakota, United States, 57117-5134

Contacts

Principal Investigator:

Daniel Almquist

Baptist Memorial Hospital and Cancer Center-Collierville

Recruiting

Collierville, Tennessee, United States, 38017

Contacts

Principal Investigator:

Shelby Lane

Baptist Memorial Hospital and Cancer Center-Memphis

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

Principal Investigator:

Shelby Lane

Duluth Clinic Ashland

Recruiting

Ashland, Wisconsin, United States, 54806

Contacts

Principal Investigator:

Bret E. Friday

Northwest Wisconsin Cancer Center

Recruiting

Ashland, Wisconsin, United States, 54806

Contacts

Principal Investigator:

Bret E. Friday

Essentia Health-Hayward Clinic

Recruiting

Hayward, Wisconsin, United States, 54843

Contacts

Principal Investigator:

Bret E. Friday

Essentia Health-Spooner Clinic

Recruiting

Spooner, Wisconsin, United States, 54801

Contacts

Principal Investigator:

Bret E. Friday

Essentia Health Saint Mary's Hospital - Superior

Recruiting

Superior, Wisconsin, United States, 54880

Contacts

Site Public Contact

701-364-6272

Principal Investigator:

Bret E. Friday

More Information

Sponsor

Alliance for Clinical Trials in Oncology

Last update posted

Sep 2, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-06. This information was provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology on 2026-09-02.