Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06008730

Proton Beam Radiation Therapy After Treatment for Resected N2 Non-Small Cell Lung Cancer

Led by Emory University · Updated on 2025-11-10

20

Participants Needed

1

Research Sites

159 weeks

Total Duration

On this page

Sponsors

E

Emory University

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This clinical trial tests proton beam radiation therapy in patients with non-small cell lung cancer who have undergone surgical resection and have lymph nodes involving the middle of the chest. Proton therapy is a type of radiation treatment that kills cancer cells while avoiding surrounding healthy tissue. Proton beam therapy is sometimes used after cancer surgery to reduce the risk of cancer recurrence (coming back). Giving proton beam radiation therapy may work better than conventional radiation treatment after surgery in patients with non-small cell lung cancer.

CONDITIONS

Official Title

Proton Beam Radiation Therapy After Treatment for Resected N2 Non-Small Cell Lung Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 2 18 years
  • Complete surgical removal of lung cancer after pre-operative systemic therapy, including lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy with lymph node dissection of at least three mediastinal stations
  • Pathology report confirming complete primary tumor resection (R0) and involvement of at least one mediastinal lymph node (pN2) with no tumor in highest dissected node; patients with initially positive margins cleared by additional margins are eligible
  • Eastern Cooperative Oncology Group performance status 1 or Karnofsky score 60%
  • Life expectancy longer than 12 weeks
  • Hemoglobin level 2 9.0 g/dl without recent transfusions
  • White blood cell count 2 2000/uL without recent growth factor support or transfusions
  • Platelet count 2 100,000/mcL without recent transfusions
  • Serum creatinine 2 mg/dL or glomerular filtration rate 340 mL/min
  • Female participants of child-bearing potential must have a negative pregnancy test before therapy
  • Female participants of child-bearing potential and male participants must agree to use effective contraception during and after the study
  • Completion of all previous cancer therapies at least 2 weeks before starting radiotherapy
  • Patients with cardiac disease history must have New York Heart Association Functional Classification class 2B or better
  • Willingness and ability to comply with study visits, treatments, laboratory tests, and procedures
  • Signed informed consent acknowledging study procedures, risks, benefits, and experimental nature
Not Eligible

You will not qualify if you...

  • Stage IV disease
  • Systemic therapy within 2 weeks prior to starting radiotherapy
  • Prior thoracic radiotherapy
  • Previous history of non-small cell lung cancer other than current diagnosis
  • Small cell lung cancer diagnosis
  • Tumors with targetable EGFR or ALK alterations
  • Incomplete surgical resection including microscopic or macroscopic residual disease, fewer than three mediastinal lymph node stations sampled, unremoved positive lymph nodes, malignant pleural or pericardial effusion
  • Use of other investigational agents or devices within 21 days before study treatment
  • Uncontrolled illness such as active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social issues limiting compliance
  • Significant cardiovascular events within 3 months before study, symptomatic peripheral vascular disease, severe congestive heart failure, or uncontrolled high blood pressure despite treatment
  • Vulnerable populations including adults unable to consent, minors, pregnant women, and prisoners

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States, 30322

Actively Recruiting

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Research Team

B

Bill Stokes, MD

CONTACT

A

Aparna H. Kesarwala, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Proton Beam Radiation Therapy After Treatment for Resected N2 Non-Small Cell Lung Cancer | DecenTrialz