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New treatment option for Lung Non-Small Cell Carcinoma
Official title A Study of Targeted Post-Surgery Radiation Therapy for Non-Small Cell Lung Cancer With Remaining Lymph Node Cancer After Treatment
ClinicalTrials.gov ID: NCT07293247
What this study is testing
What is Chemotherapy?
Chemotherapy is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for lung non-small cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- No metastatic disease (M0) per head CT/MRI imaging
See the full 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...
- 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...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- 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...
- 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...
- HIV-infected patients on effective anti-retroviral therapy with an undetectable viral load within 6 months are eligible for this trial
The study team makes the final eligibility decision.
Where it's taking place
- Jonesboro, Arkansas, United States
- Decatur, Illinois, United States
- O'Fallon, Illinois, United States
- Ann Arbor, Michigan, United States
- Brighton, Michigan, United States
- Canton, Michigan, United States
- Chelsea, Michigan, United States
- Livonia, Michigan, United States
- Ypsilanti, Michigan, United States
- Brainerd, Minnesota, United States
- Deer River, Minnesota, United States
- Duluth, Minnesota, United States
- Hibbing, Minnesota, United States
- Sandstone, Minnesota, United States
- Virginia, Minnesota, United States
- Southhaven, Mississippi, United States
- The Bronx, New York, United States
- Chapel Hill, North Carolina, United States
- Collierville, Tennessee, United States
- Memphis, Tennessee, United States
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jonesboro, Arkansas, United States; Decatur, Illinois, United States; O'Fallon, Illinois, United States; Ann Arbor, Michigan, United States; Brighton, Michigan, United States; Canton, Michigan, United States and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.