Resectable Lung Non-Small Cell CarcinomaPhase 2NCT06008730
Proton Beam Radiation Therapy After Treatment for Resected N2 Non-Small Cell Lung Cancer
A Phase 2 study testing Biospecimen Collection, Proton Beam Radiation Therapy and Radiology, Treatment Planning in people with Resectable Lung Non-Small Cell Carcinoma, run by Emory University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Lung Non-Small Cell Carcinoma
- What is being tested?
- Biospecimen Collection, Proton Beam Radiation Therapy and Radiology, Treatment Planning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2024to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years
- Patients must have undergone complete surgical resection after pre-operative systemic therapy. Complete resections are defined as BOTH lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy AND lymph node dissection with at least three mediastinal (N2) stations sampled
- Pathology report from surgical resection indicating complete resection of primary tumor (R0 resection) AND tumor involvement of at least one mediastinal lymph node (pN2) AND no tumor involvement of highest dissected mediastinal lymph node. Patients who have initially positive margins that are secondarily cleared on additional margins will be eligible
- Eastern Cooperative Oncology Group Performance (ECOG) performance status =< 2 (Karnofsky >= 60%)
- Life expectancy > 12 weeks as determined by the investigator
- Hemoglobin >= 9.0 g/dl (no transfusions allowed within 7 days of simulation to meet entry criteria) (within 28 days of cycle 1 day 1)
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- White blood cell >= 2000/uL (after at least 7 days without growth factor support or transfusion) (within 28 days of cycle 1 day 1)
- Platelets >= 100,000/mcL (no transfusions allowed within 7 days of cycle 1 day 1 to meet entry criteria) (within 28 days of cycle 1 day 1)
- Serum creatinine =< 2 mg/dL (or glomerular filtration rate >= 40 mL/min) (within 28 days of cycle 1 day 1)
- Because radiotherapy is known to be teratogenic, female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy
- FCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of radiotherapy. A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months
- Completion of all previous therapy (including surgery, chemotherapy, or investigational therapy) for the treatment of cancer >= 2 weeks before the start of radiotherapy
- 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
- Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions
- Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation
Who cannot join
- Patients who have stage IV disease
- Patients who have had systemic therapy less than 2 weeks prior to anticipated radiotherapy start
- Patients who have received prior thoracic radiotherapy
- Patients who have a prior history of NSCLC (other than index diagnosis)
- Patients who have small cell lung cancer
- Patients whose tumors exhibit targetable alterations in EGFR or ALK
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- Patients with incomplete surgical resection, including R1 (microscopic residual disease) or R2 resection (macroscopic residual disease), sampling of fewer than three mediastinal lymph node stations, unremoved positive lymph nodes, malignant pleural effusion, or malignant pericardial effusion
- Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Significant cardiovascular disease (eg, myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of study therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; or uncontrolled grade >= 3 hypertension (diastolic blood pressure >= 100 mmHg or systolic blood pressure >= 160 mmHg) despite antihypertensive therapy
- The following vulnerable populations will not be offered participation in this study:
- Adults with cognitive impairment or unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Tegan VandenBosch, tegan.honor.vandenbosch@emory.edu
William Stokes, MD
About this study
Official title: Proton Beam Radiation Therapy in Patients With Resected N2 Non-Small Cell Lung Cancer
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the safety of proton beam radiation therapy (PBRT) for resected N2 non-small cell lung cancer (NSCLC).
SECONDARY OBJECTIVES:
- To measure the radiation dose to the circulating immune compartment and explore its association with clinical endpoints.
II. To assess the efficacy of PBRT for resected N2 NSCLC.
OUTLINE:
Patients undergo radiation treatment planning and then undergo proton beam radiation therapy on study. Patients also undergo collection of blood samples.
Patients are followed up for 24 months after first dose of radiotherapy.
- Conditions
- Resectable Lung Non-Small Cell Carcinoma
- Being tested
- Biospecimen Collection, Proton Beam Radiation Therapy, Radiology, Treatment Planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood samples
Proton Beam Radiation TherapyRadiation
Also called External beam radiation therapy protons (procedure), External Beam Radiotherapy (protons), PBRT, Proton
Undergo proton beam radiation therapy
Radiology, Treatment PlanningOther
Undergo radiation treatment planning
| Study group | Role | What they receive |
|---|---|---|
| Treatment (proton beam radiation therapy) | Experimental | Patients undergo radiation treatment planning and then undergo proton beam radiation therapy on study. Patients also undergo collection of blood samples. Receives: Procedure: Biospecimen Collection; Radiation: Proton Beam Radiation Therapy; Other: Radiology, Treatment Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
AEs will be categorized according to Common Terminology Criteria for Adverse Events (CTCAE) and classified as either early (occurring any time from enrollment through 90 days) or late (occurring any time from 90 days through 2 years). Will also categorize toxicity according to grade and separately report toxicity of any grade and toxicity of high grade (grade 3 or greater). Descriptive statistics will be used to summarize the data.
Measured: Up to 90 days from enrollment
Secondary outcomes (3)
Radiation dose to immune compartment
Measured: Single episode prior to first radiation treatment
Disease-free survival
Examine the association of dose with disease-free survival. Cox proportional hazard model along with Kalan-Meier method will be applied.
Measured: From date of surgery to the date of local, regional, or distant recurrence or death, whichever earlier, with censoring at the date of the last follow up, assessed up to 24 months after first dose of radiation
Overall survival
Examine the association of dose with overall survival. Cox proportional hazard model along with Kaplan-Meier method will be applied.
Measured: From the date of surgery to the date of death with censoring at date of last follow up if alive, assessed up to 24 months after first dose of radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start13 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Bill Stokes, Emory University
- Investigators
- William Stokes, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008730
- Sponsor's protocol ID
- STUDY00005105
- Other IDs
- NCI-2023-02941, STUDY00005105, RAD5621-22, P30CA138292
- Status last verified
- Sep 2026
- First submitted
- 31 Jul 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Beam Radiation Therapy in Patients With Resected N2 Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06008730
- Acronym / sponsor ID
- STUDY00005105
- Conditions
- Resectable Lung Non-Small Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To assess the safety of proton beam radiation therapy (PBRT) for resected N2 non-small cell lung cancer (NSCLC).
SECONDARY OBJECTIVES:
- To measure the radiation dose to the circulating immune compartment and explore its association with clinical endpoints.
II. To assess the efficacy of PBRT for resected N2 NSCLC.
OUTLINE:
Patients undergo radiation treatment planning and then undergo proton beam radiation therapy on study. Patients also undergo collection of blood samples.
Patients are followed up for 24 months after first dose of radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (proton beam radiation therapy) | Experimental | Procedure: Biospecimen Collection, Radiation: Proton Beam Radiation Therapy, Other: Radiology, Treatment PlanningPatients undergo radiation treatment planning and then undergo proton beam radiation therapy on study. Patients also undergo collection of blood samples. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age >= 18 years
- Patients must have undergone complete surgical resection after pre-operative systemic therapy. Complete resections are defined as BOTH lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy AND lymph node dissection with at least three mediastinal (N2) stations sampled
- Pathology report from surgical resection indicating complete resection of primary tumor (R0 resection) AND tumor involvement of at least one mediastinal lymph node (pN2) AND no tumor involvement of highest dissected mediastinal lymph node. Patients who have initially positive margins that are secondarily cleared on additional margins will be eligible
- Eastern Cooperative Oncology Group Performance (ECOG) performance status =< 2 (Karnofsky >= 60%)
- Life expectancy > 12 weeks as determined by the investigator
Key exclusion criteria (15 listed)
- Patients who have stage IV disease
- Patients who have had systemic therapy less than 2 weeks prior to anticipated radiotherapy start
- Patients who have received prior thoracic radiotherapy
- Patients who have a prior history of NSCLC (other than index diagnosis)
- Patients who have small cell lung cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood samples | Procedure or surgery | Treatment (proton beam radiation therapy) |
| Proton Beam Radiation TherapyAlso: External beam radiation therapy protons (procedure), External Beam Radiotherapy (protons), PBRT, ProtonUndergo proton beam radiation therapy | Radiation | Treatment (proton beam radiation therapy) |
| Radiology, Treatment PlanningUndergo radiation treatment planning | Other | Treatment (proton beam radiation therapy) |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Up to 90 days from enrollment
AEs will be categorized according to Common Terminology Criteria for Adverse Events (CTCAE) and classified as either early (occurring any time from enrollment through 90 days) or late (occurring any time from 90 days through 2 years). Will also categorize toxicity according to grade and separately report toxicity of any grade and toxicity of high grade (grade 3 or greater). Descriptive statistics will be used to summarize the data.
3 secondary outcomes
Radiation dose to immune compartment
Time frame: Single episode prior to first radiation treatment
Disease-free survival
Time frame: From date of surgery to the date of local, regional, or distant recurrence or death, whichever earlier, with censoring at the date of the last follow up, assessed up to 24 months after first dose of radiation
Overall survival
Time frame: From the date of surgery to the date of death with censoring at date of last follow up if alive, assessed up to 24 months after first dose of radiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Stokes principal investigator
Emory University Hospital/Winship Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biospecimen Collection, Proton Beam Radiation Therapy and Radiology, Treatment Planning in people with Resectable Lung Non-Small Cell Carcinoma, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bill Stokes, MD (404-778-3473, william.stokes@emoryhealthcare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (time frame: Up to 90 days from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.