RightFit
RecruitingPhase 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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years, 3 years
  • Procedures mentioned: X-rays, Blood draws, MRI scans, CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Radiation therapy uses high-energy X-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors."
  • "Patients also undergo computed tomography (CT) and/or magnetic resonance imaging (MRI), fludeoxyglucose-positron emission tomography (FDG-PET), and blood sample collection throughout the study."
  • "Patients also undergo CT and/or MRI, FDG-PET, and blood sample collection throughout the study."
  • "After completion of study treatment, patients are followed up every 3 months for 2 years, and then every 6 months for 3 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding targeted radiation after surgery lowers the chance of lung cancer coming back. It is for adults with non-small cell lung cancer whose removed lymph nodes still showed cancer after treatment before surgery. It compares radiation followed by usual chemotherapy or immunotherapy with usual treatment alone.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older, with non-small cell lung cancer confirmed by a tissue test.
  • Had 2–4 rounds of drug treatment before surgery using a recommended treatment plan.
  • Had at least one lung lobe removed within 8 weeks before signing up. Surgery must have removed all cancer, but removed lymph nodes in the middle of the chest must still have shown cancer.
  • Scans must show no cancer spread to distant parts of the body. A chest scan after drug treatment, within 90 days before signing up, must show no worsening.
  • Able to care for yourself and be out of bed or a chair for more than half the day.
  • Blood tests must meet the study’s limits for infection-fighting cells, platelets that help blood clot, and kidney and liver function.
  • If you have heart disease, heart symptoms, or past treatment that can harm the heart, a heart check must meet the study’s limit.
  • People with another cancer may join if it will not affect study safety or results. People with HIV may join if treatment works and a test within 6 months cannot detect the virus.

Who can't join

  • Any small cell lung cancer mixed with the non-small cell cancer.
  • Known cancer gene changes called EGFR mutations or ALK rearrangements.
  • Past radiation to the lungs or the area between the lungs.
  • Use of a VEGF inhibitor, a drug that blocks blood vessel growth, within 90 days before signing up, or plans to use one after surgery.
  • Pregnancy. Anyone who could become pregnant must have a negative pregnancy test within 7 days before signing up.
  • Certain lung scarring or lung inflammation that limits breathing or needs ongoing medicine to slow scarring.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (111)

AR

CA

CO

IL

KS

ME

MI

MN

MO

MS

NC

ND

NJ

NY

OH

OR

PA

SD

TN

WI