Targeted post-surgery radiation plus standard therapy for NSCLC with remaining nodal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase II randomized study in patients with resected NSCLC and ypN2 disease. It compares intensity-modulated post-operative radiation therapy (I²-PORT) followed by standard care to standard care alone. The trial evaluates disease-free survival, overall survival, local-regional control, distant metastases, and treatment-related toxicities using CTCAE v5.0 and PRO-CTCAE measures. Secondary analyses include subset effects by nodal involvement and surgical evaluation adequacy. Participants undergo imaging and blood tests per protocol to monitor response and safety.

Why it matters

Who can join: the full rules

* 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

Where it's running

• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
  Jonesboro, Arkansas, United States Recruiting
• USC / Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• AdventHealth Parker
  Parker, Colorado, United States Recruiting
• Mount Sinai Comprehensive Cancer Center at Aventura
  Aventura, Florida, United States Recruiting
• Baptist MD Anderson Cancer Center
  Jacksonville, Florida, United States Recruiting
• Mount Sinai Medical Center
  Miami Beach, Florida, United States Recruiting

+75 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Amanda Clark
• Email: lungprotocols@alliancenctn.org
• Phone: 773-702-9171

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.