A Phase I/II Study of Hypofractionated Proton Therapy for Stage II-III Non-Small Cell Lung Cancer
The purpose of this research study is to compare the effects (good and bad) on subjects and their cancer using standard chemotherapy in combination with hypofractionated proton radiation therapy. Hypofractionation is a technique that delivers higher daily doses of radiation over a shorter period of time.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 29, 2026 · Source: ClinicalTrials.gov
The study is underway but is not accepting new participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Proton Collaborative Group
- Interventions being studied
- Radiation: Radiation with Concurrent Chemotherapy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Pathologically confirmed invasive non-small cell lung cancer within 12 weeks prior to study registration. OR Pathologically confirmed invasive non-small cell lung cancer within 6 months prior to study registration if the patient received induction chemotherapy.
- AJCC (American Joint Committee on Cancer) 7th Ed. clinical stage II-III.
- ECOG Performance status 0-1 within 8 weeks prior to study registration.
- Patient must give study-specific informed consent on an IRB-approved consent prior to any research-related procedures or study treatment.
- Patient must be at least 18 years old at the time of consent.
- Patient must complete all required tests in section 4.
- Lab results per the following within 4 weeks prior to study registration:
- Absolute neutrophil count (ANC) \>1,800 cells/mm3.
- Platelets \> = 100,000 cells/mm3.
- Hemoglobin \> =10 g/dl. The use of transfusion or other intervention to achieve Hgb ≥10.0 g/dl is acceptable.
- AST/SGOT and ALT/SGPT \< 2.5 x the institutional upper limit of normal (IULN).
- Post exploratory thoracotomy must be done \> 3 weeks prior to study registration or patient did not have post exploratory thoracotomy.
- PFT (pulmonary function test) with a FEV1 \> 0.75 liters/second within 16 weeks prior to study registration.
- Patients must be evaluated by a thoracic surgeon, pulmonologist or medical oncologist and deemed medically or surgically unacceptable for resection.
- Evidence of distant metastasis (M1) involvement.
- Prior radiotherapy to thoracic area.
- Unintentional weight loss \>10% within 4 weeks prior to study registration.
- Pregnant and/or breast-feeding women, or patients (men and women) of child-producing potential not willing to use medically acceptable forms of contraception while on study treatment and for at least 12 months after study treatment. Pregnancy testing is not necessary for women who have had a hysterectomy or have not had a menstrual period for at least 24 consecutive months.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Florida Proton Therapy InstituteJacksonville, Florida
- Northwestern Medicine Chicago Proton CenterWarrenville, Illinois
- Maryland Proton Treatment CenterBaltimore, Maryland
- Princeton ProCure Management LLCSomerset, New Jersey
- Oklahoma Proton CenterOklahoma City, Oklahoma
- Hampton University Proton Therapy InstituteHampton, Virginia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 29, 2026. Always confirm current availability with the study team.